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Recent news from the US Food and Drug Administration.
Click title to see the full article at the FDA
website. For the most up-to-date headlines, check out the FDA
Newsroom. Press announcements from 2004 to 2009 are available through
the FDA
Archive.
FDA
Recalls: FDA posts press releases and other notices of recalls and
market withdrawals from the firms involved as a service to consumers,
the media, and other interested parties. FDA does not endorse either the
product or the company. This site does not contain a complete list of
recalls -
search for recalls at the official FDA site.
| December 28, 2021 - Coronavirus
(COVID-19) Update: December 28, 2021 |
| December 23, 2021 - Coronavirus
(COVID-19) Update: December 23, 2021 |
| December 23, 2021 - Coronavirus
(COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment
of COVID-19 in Certain Adults |
| December 23, 2021 - FDA
Authorizes Marketing of Tobacco Products that Help Reduce Exposure
to and Consumption of Nicotine for Smokers Who Use Them |
| December 22, 2021 - FDA
In Brief: FDA Announces Outbreak Investigation of Listeria monocytogenes
Found in Dole Packaged Salad |
| December 22, 2021 - Coronavirus
(COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment
of COVID-19 |
| December 21, 2021 - Coronavirus
(COVID-19) Update: December 21, 2021 |
| December 21, 2021 - FDA
In Brief: FDA Announces Outbreak Investigation of Listeria monocytogenes
Found in Fresh Express Packaged Salad |
| December 21, 2021 - FDA
Conditionally Approves First Oral Tablet to Treat Chemotherapy-Induced
Diarrhea in Dogs |
| December 21, 2021 - FDA
Grants Marketing Authorization for Inferior Vena Cava Filter Removal
Device |
| December 20, 2021 - FDA
Approves First Injectable Treatment for HIV Pre-Exposure Prevention |
| December 17, 2021 - FDA
Approves New Treatment for Myasthenia Gravis |
| December 17, 2021 - Coronavirus
(COVID-19) Update: December 17, 2021 |
| December 15, 2021 - FDA
Approves First Drug to Prevent Graft Versus Host Disease |
| December 14, 2021 - Coronavirus
(COVID-19) Update: December 14, 2021 |
| December 10, 2021 - Coronavirus
(COVID-19) Update: December 10, 2021 |
| December 10, 2021 - FDA
In Brief: FDA Publishes Discussion Paper and Seeks Public Input on
3D Printing of Medical Devices at the Point of Care |
| December 9, 2021 - Coronavirus
(COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19
Booster Dose to 16- and 17-Year-Olds |
| December 9, 2021 - FDA
Issues Improvement Plan Focused on Modernizing Foodborne Illness Outbreak
Responses |
| December 8, 2021 - Coronavirus
(COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies
for Pre-exposure Prevention of COVID-19 in Certain Individuals |
| December 7, 2021 - Coronavirus
(COVID-19) Update: December 7, 2021 |
| December 7, 2021 - FDA
In Brief: FDA Takes New Steps Aimed at Advancing Development of Individualized
Medicines to Treat Genetic Diseases |
| December 3, 2021 - FDA
Expands Authorization of Two Monoclonal Antibodies for Treatment and
Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients,
Including Newborns |
| December 2, 2021 - FDA
Proposes Changes to Food Safety Modernization Act Rule to Enhance
Safety of Agricultural Water Used on Produce |
| November 30, 2021 - Coronavirus
(COVID-19) Update: November 30, 2021 |
| November 30, 2021 - Coronavirus
(COVID-19) Update: FDA Actively Working to Investigate, Address Potential
Impacts of Omicron Variant; Urges Vaccination and Boosters |
| November 29, 2021 - FDA
Approves New Imaging Drug to Help Identify Ovarian Cancer Lesions
|
| November 23, 2021 - FDA
Approves First Treatment for Common Type of Post-Transplant Infection
that is Resistant to Other Drugs |
| November 23, 2021 - Coronavirus
(COVID-19) Update: November 23, 2021 |
| November 19, 2021 - FDA
Approves First Drug to Improve Growth in Children with Most Common
Form of Dwarfism |
| November 19, 2021 - Coronavirus
(COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters |
| November 19, 2021 - FDA
In Brief: FDA Issues Final Orders Reclassifying Certain Hepatitis
C Diagnostic Tests from Class III to Class II |
| November 16, 2021 - Coronavirus
(COVID-19) Update: November 16, 2021 |
| November 16, 2021 - FDA
In Brief: FDA Announces Investigation of E. coli O157:H7 Outbreak
Linked to Spinach |
| November 16, 2021 - FDA
Authorizes Marketing of Virtual Reality System for Chronic Pain Reduction |
| November 15, 2021 - Coronavirus
(COVID-19) Update: FDA Updates Test Policies to Help to Ensure Accuracy
and Reliability of Tests and Increase Access to At-Home Tests |
| November 12, 2021 - FDA
Approves Treatment for Rare Blood Disease |
| November 12, 2021 - Coronavirus
(COVID-19) Update: November 12, 2021 |
| November 12, 2021 - FDA
Provides Update on Recall of Certain Philips Respironics Breathing
Assistance Machines |
| November 5, 2021 - Coronavirus
(COVID-19) Update: November 5, 2021 |
| November 3, 2021 - FDA
In Brief: FDA Provides New Draft Guidance on Premarket Submissions
for Device Software Functions |
| November 2, 2021 - Coronavirus
(COVID-19) Update: November 2, 2021 |
| October 29, 2021 - Coronavirus
(COVID-19) Update: October 29, 2021 |
| October 29, 2021 - FDA
Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children
5 through 11 Years of Age |
| October 27, 2021 - FDA,
NIH, and 15 private organizations join forces to increase effective
gene therapies for rare diseases |
| October 27, 2021 - FDA
Strengthens Safety Requirements and Updates Study Results for Breast
Implants |
| October 27, 2021 - FDA
In Brief: FDA Collaborates with Health Canada and UK’s MHRA to
Foster Good Machine Learning Practice |
| October 26, 2021 - Coronavirus
(COVID-19) Update: October 26, 2021 |
| October 25, 2021 - FDA
In Brief: FDA Makes Progress on Efforts to Understand Presence of
Asbestos in Cosmetic Products |
| October 22, 2021 - Coronavirus
(COVID-19) Update: October 22, 2021 |
| October 20, 2021 - FDA
In Brief: FDA Announces Investigation of Salmonella Outbreak Linked
to Whole, Fresh Onions |
| October 20, 2021 - Coronavirus
(COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster
Dose for COVID-19 Vaccines |
| October 20, 2021 - Federal
Judge Enters Consent Decree with Utah-based Dietary Supplement Manufacturer |
| October 19, 2021 - Coronavirus
(COVID-19) Update: October 19, 2021 |
| October 19, 2021 - FDA
Issues Landmark Proposal to Improve Access to Hearing Aid Technology
for Millions of Americans |
| October 19, 2021 - FDA
Permits Marketing of New Oral Tobacco Products through Premarket Tobacco
Product Application Pathway |
| October 18, 2021 - FDA
Approves Cyltezo, the First Interchangeable Biosimilar to Humira |
| October 15, 2021 - Coronavirus
(COVID-19) Update: 10/15/21 |
| October 14, 2021 - FDA
to Hold Advisory Committee Meeting to Discuss Merck and Ridgeback’s
EUA Application for COVID-19 Oral Treatment |
| October 14, 2021 - FDA
Awards 11 Grants to Clinical Trials to Develop New Medical Products
for Rare Disease Treatments |
| October 13, 2021 - To
Improve Nutrition and Reduce the Burden of Disease, FDA Issues Food
Industry Guidance for Voluntarily Reducing Sodium in Processed and
Packaged Foods |
| October 12, 2021 - Coronavirus
(COVID-19) Update: October 12, 2021 |
| October 12, 2021 - FDA
Permits Marketing of E-Cigarette Products, Marking First Authorization
of Its Kind by the Agency |
| October 8, 2021 - FDA
Approves Innovative Treatment for Pediatric Patients with Congenital
Athymia |
| October 8, 2021 - Coronavirus
(COVID-19) Update: October 8, 2021 |
| October 8, 2021 - FDA
In Brief: FDA Warns Public and Health Care Professionals Not to Use
Needle-free Devices for Injection of Dermal Fillers |
| October 7, 2021 - FDA
Issues Final Order and Guidance on Surgical Staplers and Staples for
Internal Use |
| October 7, 2021 - FDA
Announces Signing of Domestic Mutual Reliance Agreements with California,
Florida, Utah and Wisconsin |
| October 7, 2021 - FDA
In Brief: FDA Warns Firms for Continuing to Market E-cigarette Products
After Agency Denied Authorizations |
| October 6, 2021 - FDA
Revises Hospital and Health System Compounding Guidance to Help Preserve
Patient Access to Compounded Drugs |
| October 5, 2021 - Coronavirus
(COVID-19) Update: October 5, 2021 |
| October 4, 2021 - Coronavirus
(COVID-19) Update: FDA Authorizes Additional OTC Home Test to Increase
Access to Rapid Testing for Consumers |
| October 4, 2021 - FDA
Finalizes Two Foundational Rules for Companies Seeking to Market New
Tobacco Products |
| October 1, 2021 - Federal
officials seize spices and food additive products held under insanitary
conditions from a Florida warehouse |
| October 1, 2021 - Coronavirus
(COVID-19) Update: October 1, 2021 |
| October 1, 2021 - FDA
to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization
for Booster Doses and COVID-19 Vaccines for Younger Children |
| September 30, 2021 - Youth
E-cigarette Use Remains Serious Public Health Concern Amid COVID-19
Pandemic |
| September 30, 2021 - FDA
Clears First Major Imaging Device Advancement for Computed Tomography
in Nearly a Decade |
| September 29, 2021 - FDA
In Brief: FDA Warns Consumers of Risk of Exposure to Unsafe Levels
of Radiation with Safe-T-Lite UV WAND |
| September 24, 2021 - FDA
Takes Steps Aimed at Improving Quality, Safety and Efficacy of Sunscreens |
| September 22, 2021 - FDA
Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain
Populations |
| September 22, 2021 - FDA
Issues Draft Guidance on Donor Eligibility and Manufacturing of Cellular
Therapies for Animals |
| September 22, 2021 - FDA
In Brief: FDA Publishes Material Safety Data to Promote Safer, More
Effective Medical Devices |
| September 21, 2021 - FDA
Authorizes Software that Can Help Identify Prostate Cancer |
| September 20, 2021 - FDA
In Brief: FDA Posts an Initial Batch of Four Deemed Final Administrative
Orders for Over-the-Counter Drugs |
|
September 17, 2021 - Coronavirus
(COVID-19) Update: September 17, 2021
|
| September 17, 2021 - Federal
Court Enters Consent Decree Against Florida Compounder, Prohibiting
Manufacture and Distribution of Drugs Due to Insanitary Conditions |
| September 17, 2021 - FDA
In Brief: FDA Hosts Third Summit Focused on Reducing the Availability
of Opioids Online |
| September 15, 2021 - FDA
Advances Data, IT Modernization Efforts with New Office of Digital
Transformation |
| September 13, 2021 - FDA
In Brief: FDA Announces Winners of Food Traceability Challenge |
| September 10, 2021 - Coronavirus
(COVID-19) Update: September 10, 2021 |
| September 10, 2021 - FDA
Will Follow The Science On COVID-19 Vaccines For Young Children |
| September 9, 2021 - FDA
Makes Significant Progress in Science-Based Public Health Application
Review, Taking Action on Over 90% of More Than 6.5 Million ‘Deemed’
New Tobacco Products Submitted |
| September 9, 2021 - FDA,
FTC Warn 10 Companies Illegally Selling Dietary Supplements Claiming
to Treat Diabetes |
| September 9, 2021 - FDA
In Brief: As Consumers Order More Meals and Groceries Online, FDA
Plans Public Meeting to Address Food Safety Risks |
| September 8, 2021 - FDA
In Brief: FDA Announces Public Workshop to Reconsider Mandatory Prescriber
Education for Opioids |
| September 7, 2021 - Coronavirus
(COVID-19) Update: September 7, 2021 |
| September 2, 2021 - FDA
In Brief: FDA Reaches Milestone in Competitive Generic Therapy Drug
Approvals |
| September 1, 2021 - FDA
In Brief: FDA to Hold Advisory Committee Meeting to Discuss Pfizer-BioNTech’s
Application for COVID-19 Booster |
| August 31, 2021 - Coronavirus
(COVID-19) Update: August 31, 2021 |
| August 27, 2021 - Coronavirus
(COVID-19) Update: August 27, 2021 |
| August 27, 2021 - FDA
Approves First-of-Its-Kind Stroke Rehabilitation System |
| August 26, 2021 - FDA
Denies Marketing Applications for About 55,000 Flavored E-Cigarette
Products for Failing to Provide Evidence They Appropriately Protect
Public Health |
| August 26, 2021 - FDA
Releases PFAS Testing Results from First Survey of Nationally Distributed
Processed Foods |
| August 24, 2021 - Coronavirus
(COVID-19) Update: August 24, 2021 |
| August 23, 2021 - FDA
and Mexican Counterparts Report Progress and Next Steps for Food Safety
Partnership |
| August 23, 2021 - FDA
Approves First COVID-19 Vaccine |
| August 20, 2021 - Coronavirus
(COVID-19) Update: August 20, 2021 |
| August 18, 2021 - Joint
Statement from HHS Public Health and Medical Experts on COVID-19 Booster
Shots |
| August 17, 2021 - FDA
In Brief: FDA Issues a Corporate-Wide Warning Letter to Company Associated
with Contaminated Pet Food, Hundreds of Adverse Events |
| August 13, 2021 - Coronavirus
(COVID-19) Update: August 13, 2021 |
| August 12, 2021 - Coronavirus
(COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain
Immunocompromised Individuals |
| August 12, 2021 - FDA
Grants First of its Kind Indication for Chronic Sleep Disorder Treatment
|
| August 6, 2021 - Coronavirus
(COVID-19) Update: August 6, 2021 |
| August 6, 2021 - FDA
Approves New Treatment for Pompe Disease |
| August 5, 2021 - FDA
In Brief: FDA Reminds Industry of Specific Regulations for the Use
of Fluorinated Polyethylene in Food Contact Containers |
| August 4, 2021 - FDA
Participates in New ‘Collaborative Communities’ to Address
Emerging Challenges in Medical Devices |
| August 3, 2021 - Coronavirus
(COVID-19) Update: August 3, 2021 |
| July 30, 2021 - Coronavirus
(COVID-19) Update: July 30, 2021 |
| July 28, 2021 - FDA
Approves First Interchangeable Biosimilar Insulin Product for Treatment
of Diabetes |
| July 28, 2021 - FDA
In Brief: FDA Warns Firm with Over 15 Million Products Listed with
FDA to Remove Unauthorized E-Cigarette Products from Market |
| July 23, 2021 - Coronavirus
(COVID-19) Update: July 23, 2021 |
| July 20, 2021 - Coronavirus
(COVID-19) Update: July 20, 2021 |
| July 16, 2021 - Coronavirus
(COVID-19) Update: July 16, 2021 |
| July 15, 2021 - FDA
Grants First Full Approval for Treatment of Lymphoma in Dogs |
| July 13, 2021 - Coronavirus
(COVID-19) Update: July 13, 2021 |
| July 9, 2021 - Coronavirus
(COVID-19) Update: July 9, 2021 |
| July 9, 2021 - FDA
In Brief: FDA Issues Systems Recognition Draft Guidance |
| July 8, 2021 - Joint
CDC and FDA Statement on Vaccine Boosters |
| July 6, 2021 - Coronavirus
(COVID-19) Update: July 6, 2021 |
| July 2, 2021 - Coronavirus
(COVID-19) Update: July 2, 2021 |
| July 1, 2021 - FDA
Releases Cyclospora Prevention, Response and Research Action Plan |
| June 30, 2021 - FDA
Approves Component of Treatment Regimen for Most Common Childhood
Cancer |
| June 30, 2021 - FDA
In Brief: FDA Revokes Emergency Use Authorizations for Certain Respirators
and Decontamination Systems as Access to N95s Increases Nationwide |
| June 30, 2021 - FDA
Provides Update on Ongoing Efforts to Better Understand the Occurrence
of PFAS in the Food Supply |
| June 29, 2021 - Coronavirus
(COVID-19) Update: June 29, 2021 |
| June 25, 2021 - Coronavirus
(COVID-19) Update: June 25, 2021 |
| June 24, 2021 - Coronavirus
(COVID-19) Update: FDA Authorizes Drug for Treatment of COVID-19 |
| June 24, 2021 - FDA
In Brief: FDA Encourages Inclusion of Patients with Incurable Cancers
in Oncology Clinical Trials Regardless of Prior Therapies |
| June 22, 2021 - Coronavirus
(COVID-19) Update: June 22, 2021 |
| June 21, 2021 - FDA
Approves First Oral Blood Thinning Medication for Children |
| June 17, 2021 - FDA
Approves a Nasal Antihistamine for Nonprescription Use |
| June 17, 2021 - FDA
In Brief: FDA Announces Qualification of a Medical Device Development
Tool to Help Assess Patient- Reported Outcomes with LASIK Surgery |
| June 17, 2021 - FDA
In Brief: FDA Issues Draft Guidance on Remanufacturing and Discussion
Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices |
| June 15, 2021 - Coronavirus
(COVID-19) Update: June 15, 2021 |
| June 15, 2021 - FDA
Approves StrataGraft for the Treatment of Adults with Thermal Burns |
| June 11, 2021 - Coronavirus
(COVID-19) Update: June 11, 2021 |
| June 11, 2021 - FDA
Takes Steps to Increase Availability of COVID-19 Vaccine |
| June 9, 2021 - FDA
In Brief: FDA Provides Guidance on Measuring Patient-Reported Outcomes
in Cancer Clinical Trials |
| June 8, 2021 - Coronavirus
(COVID-19) Update: June 8, 2021 |
| June 7, 2021 - FDA
Grants Accelerated Approval for Alzheimer’s Drug |
| June 4, 2021 - FDA
Approves First Treatment for Patients with Plasminogen Deficiency,
a Rare Genetic Disorder |
| June 4, 2021 - Coronavirus
(COVID-19) Update: June 4, 2021 |
| June 4, 2021 - FDA
Approves New Drug Treatment for Chronic Weight Management, First Since
2014 |
| June 3, 2021 - FDA
In Brief: FDA provides new guidance to further enhance the security
of prescription drugs in the U.S. supply chain |
| June 3, 2021 -
FDA Alerts Health Care Providers to Stop New Implants of Certain Ventricular
Assist Device System |
| June 2, 2021 - FDA
Authorizes Marketing of Diagnostic Aid for Autism Spectrum Disorder |
| June 1, 2021 - Coronavirus
(COVID-19) Update: June 1, 2021 |
| June 1, 2021 - Nevada-Based
Bottled Water Manufacturer Agrees to Stop Production for Failure to
Comply with Manufacturing Requirements |
| June 1, 2021 - FDA
Launches Challenge to Spur Development of Affordable Traceability
Tools as Part of Broader Food Safety Efforts |
| May 28, 2021 - Coronavirus
(COVID-19) Update: May 28, 2021 |
| May 28, 2021 - FDA
Seeks $6.5 Billion to Further Investments in Critical Public Health
Infrastructure, Core Food Safety and Medical Product Safety Programs |
| May 28, 2021 - FDA
Approves First Targeted Therapy for Lung Cancer Mutation Previously
Considered Resistant to Drug Therapy |
| May 26, 2021 - Coronavirus
(COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for
Treatment of COVID-19 |
| May 26, 2021 - FDA,
FTC Warn Five Companies Illegally Selling Dietary Supplements Claiming
to Treat Infertility |
| May 26, 2021 - FDA
In Brief: FDA Announces Draft Guidances to Help Increase Transparency,
Assist Reporting and Timely Completion for Certain Medical Device
Studies after FDA Approval or Clearance |
| May 25, 2021 - Coronavirus
(COVID-19) Update: May 25, 2021 |
| May 21, 2021 - FDA
Announces Seizure of Adulterated Dietary Supplements Containing Kratom |
| May 21, 2021 - Coronavirus
(COVID-19) Update: May 21, 2021 |
| May 21, 2021 - FDA
Approves First Targeted Therapy for Subset of Non-Small Cell Lung
Cancer |
| May 20, 2021 - FDA
In Brief: FDA Solicits Public Feedback on Discussion Paper as Part
of its Ongoing Commitment to Patient Safety |
| May 20, 2021 - FDA
In Brief: FDA Alerts Patients and Health Care Providers About Possible
Problems with Mammograms Performed at Capitol Radiology LLC |
| May 19, 2021 - FDA
In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed
Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine
More Widely Available |
| May 19, 2021 - FDA
In Brief: FDA Issues Draft Guidance on Early Clinical Studies for
Certain Medical Devices to Improve Glycemic Control for Type 2 Diabetes |
| May 19, 2021 - FDA
In Brief: FDA Advises Against Use of SARS-CoV-2 Antibody Test Results
to Evaluate Immunity or Protection From COVID-19, Including After
Vaccination |
| May 18, 2021 - Coronavirus
(COVID-19) Update: May 18, 2021 |
| May 18, 2021 - FDA
In Brief: Science Forum Highlights Regulatory Science Advancements
in Protecting and Promoting Public Health |
| May 17, 2021 - FDA
In Brief: FDA Provides Guidance on Master Protocols for Evaluating
Prevention, Treatment Options for COVID-19 |
| May 14, 2021 - Coronavirus
(COVID-19) Update: May 14, 2021 |
| May 13, 2021 - FDA
In Brief: FDA Releases Investigation Report Following 2020 Salmonella
Outbreak Linked to Red Onions |
| May 13, 2021 - FDA
In Brief: FDA Continues to Monitor the Effects of Magnets in Consumer
Electronics on Implanted Medical Devices |
| May 11, 2021 - Coronavirus
(COVID-19) Update: May 11, 2021 |
| May 11, 2021 - FDA
In Brief: FDA Finalizes Guidance with Internationally Harmonized Recommendations
to Further Support Safe, High-Quality Human Drug Products |
| May 10, 2021 - Coronavirus
(COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine
for Emergency Use in Adolescents in Another Important Action in Fight
Against Pandemic |
| May 10, 2021 - FDA
In Brief: FDA to Hold Meeting of its Vaccines and Related Biological
Products Advisory Committee to Discuss Pediatric Use of COVID-19 Vaccines |
| May 7, 2021 - Coronavirus
(COVID-19) Update: May 7, 2021 |
| May 6, 2021 - FDA
In Brief: FDA Issues Procedural Notice on Potential Plans to Conduct
Research About Use of ‘Healthy’ Symbols on Food Products |
| May 5, 2021 - Coronavirus
(COVID-19) Update: FDA Outlines Inspection and Assessment Activities
During Pandemic, Roadmap for Future State of Operations |
| May 4, 2021 - Coronavirus
(COVID-19) Update: May 4, 2021 |
| April 30, 2021 - Coronavirus
(COVID-19) Update: April 30, 2021 |
| April 30, 2021 - FDA
Approves Treatment for Chronic Kidney Disease |
| April 30, 2021 - FDA
Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose |
| April 29, 2021 - FDA
Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing
Future Generations of Smokers |
| April 28, 2021 - FDA
Takes Action For Failure to Submit Required Clinical Trial Results
Information to ClinicalTrials.Gov |
| April 27, 2021 - Coronavirus
(COVID-19) Update: April 27, 2021 |
| April 23, 2021 - FDA
and CDC Lift Recommended Pause on Johnson & Johnson (Janssen)
COVID-19 Vaccine Use Following Thorough Safety Review |
| April 23, 2021 - Coronavirus
(COVID-19) Update: April 23, 2021 |
| April 23, 2021 - FDA
Authorizes Marketing of Device to Facilitate Muscle Rehabilitation
in Stroke Patients |
| April 22, 2021 - FDA
Approves Immunotherapy for Endometrial Cancer with Specific Biomarker |
| April 21, 2021 - FDA
Continues Important Steps to Ensure Quality, Safety and Effectiveness
of Authorized COVID-19 Vaccines |
| April 20, 2021 - Coronavirus
(COVID-19) Update: April 20, 2021 |
| April 20, 2021 - FDA
Announces New Streamlined Approach to Add Pooled Serial Screening
Claims to Certain Authorized Tests for Use in Serial Testing Programs |
| April 16, 2021 - Coronavirus
(COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal
Antibody Bamlanivimab |
| April 16, 2021 - Coronavirus
(COVID-19) Update: April 16, 2021 |
| April 16, 2021 - FDA
Approves First Immunotherapy for Initial Treatment of Gastric Cancer |
| April 14, 2021 - FDA
Provides Guidance on Remote Interactive Evaluations for Oversight
of Drug Facilities During COVID-19 |
| April 13, 2021 - Coronavirus
(COVID-19) Update: April 13, 2021 |
| April 13, 2021 - Joint
CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine |
| April 9, 2021 - FDA
Authorizes Marketing of First Device that Uses Artificial Intelligence
to Help Detect Potential Signs of Colon Cancer |
| April 9, 2021 - Coronavirus
(COVID-19) Update: April 9, 2021 |
| April 8, 2021 - FDA
Releases Action Plan for Reducing Exposure to Toxic Elements from
Foods for Babies, Young Children |
| April 6, 2021 - Coronavirus
(COVID-19) Update: April 6, 2021 |
| April 6, 2021 - FDA
Releases Investigation Report Following Fall 2020 Outbreak of E. coli
O157:H7 Illnesses Linked to Leafy Greens |
| April 6, 2021 - Coronavirus
(COVID-19) Update: FDA Issues Emergency Use Authorization for the
Symbiotica COVID-19 Self-Collected Antibody Test System |
| April 2, 2021 - Coronavirus
(COVID-19) Update: April 2, 2021 |
| April 1, 2021 - Coronavirus
(COVID-19) Update: FDA Makes Two Revisions to Moderna COVID-19 Vaccine
Emergency Use Authorization to Help Increase the Number of Vaccine
Doses Available |
| April 1, 2021 - FDA
is Investigating Reports of Infections Associated with Reprocessed
Urological Endoscopes |
| March 27, 2021 - FDA
Approves First Cell-Based Gene Therapy for Adult Patients with Multiple
Myeloma |
| March 26, 2021 - Coronavirus
(COVID-19) Update: March 26, 2021 |
| March 26, 2021 - FDA
Authorizes Marketing of Device to Improve Gait in Multiple Sclerosis
Patients |
| March 26, 2021 - FDA
Approves First in the World Device to Treat Patients with Congenital
Heart Disease |
| March 25, 2021 - FDA
Approves New indication for Drug to Treat Neurogenic Detrusor Overactivity
in Pediatric Patients |
| March 23, 2021 - Coronavirus
(COVID-19) Update: March 23, 2021 |
| March 22, 2021 - FDA
Warns Companies Illegally Selling Over-the-Counter CBD Products for
Pain Relief |
|
March 19, 2021 - Coronavirus
(COVID-19) Update: FDA Authorizes First Machine Learning-Based Screening
Device to Identify Certain Biomarkers That May Indicate COVID-19
Infection
|
| March 19, 2021 - Coronavirus
(COVID-19) Update: March 19, 2021 |
| March 17, 2021 - FDA
Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional
Premarket Review Process |
| March 16, 2021 - Coronavirus
(COVID-19) Update: March 16, 2021 |
| March 16, 2021 - Coronavirus
(COVID-19) Update: FDA takes steps to streamline path for COVID-19
screening tools, provides information to help groups establishing
testing programs |
| March 12, 2021 - Coronavirus
(COVID-19) Update: March 12, 2021 |
| March 9, 2021 - Coronavirus
(COVID-19) Update: March 9, 2021 |
| March 5, 2021 - Coronavirus
(COVID-19) Update: FDA Authorizes Adaptive Biotechnologies T-Detect
COVID Test |
| March 5, 2021 - Coronavirus
(COVID-19) Update: March 5, 2021 |
| March 5, 2021 - Coronavirus
(COVID-19) Update: FDA Issues Authorization for First Molecular Non-Prescription,
At-Home Test |
| March 5, 2021 - FDA
Announces New Actions Aimed at Further Reducing Toxic Elements in
Food for Babies, Young Children |
| March 4, 2021 - FDA
Alerts Public about Improper Use of Thermal Imaging Devices; Warns
Firms for Illegally Offering Thermal Imaging Systems for Sale |
| March 4, 2021 - Federal
judge enters permanent injunction against New York-based dietary supplement
manufacturer |
| March 2, 2021 - Coronavirus
(COVID-19) Update: March 2, 2021 |
| March 1, 2021 - FDA
Authorizes First Robotically-Assisted Surgical Device for Performing
Transvaginal Hysterectomy |
| March 1, 2021 - Coronavirus
(COVID-19) Update: FDA Issues Authorization for Quidel QuickVue At-Home
COVID-19 Test |
| February 27, 2021 - FDA
Issues Emergency Use Authorization for Third COVID-19 Vaccine |
| February 26, 2021 - FDA
Statement on Vaccines and Related Biological Products Advisory Committee
Meeting |
| February 26, 2021 - Coronavirus
(COVID-19) Update: February 26, 2021 |
| February 26, 2021 - FDA
Approves First Treatment for Molybdenum Cofactor Deficiency Type A |
| February 26, 2021 - FDA
Authorizes Marketing of Novel Device to Help Protect Athletes’
Brains During Head Impacts |
| February 25, 2021 - Coronavirus
(COVID-19) Update: FDA Allows More Flexible Storage, Transportation
Conditions for Pfizer-BioNTech COVID-19 Vaccine |
| February 25, 2021 - FDA
Approves Targeted Treatment for Rare Duchenne Muscular Dystrophy Mutation |
| February 23, 2021 - Coronavirus
(COVID-19) Update: February 23, 2021 |
| February 22, 2021 - Coronavirus
(COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers
Addressing Virus Variants |
| February 19, 2021 - Coronavirus
(COVID-19) Update: February 19, 2021 |
| February 19, 2021 - FDA
Warns 10 Companies for Illegally Selling Dietary Supplements Claiming
to Treat Depression and Other Mental Health Disorders |
| February 18, 2021 - COVID-19
Update: USDA, FDA Underscore Current Epidemiologic and Scientific
Information Indicating No Transmission of COVID-19 Through Food or
Food Packaging |
| February 17, 2021 - FDA
Approves First in the World, First-of-Its-Kind Implant for the Treatment
of Rare Bone Disease as a Humanitarian Use Device |
| February 16, 2021 - Coronavirus
(COVID-19) Update: February 16, 2021 |
| February 12, 2021 - Coronavirus
(COVID-19) Update: February 12, 2021 |
| February 12, 2021 - FDA
Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy |
| February 9, 2021 - Coronavirus
(COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment
of COVID-19 |
| February 9, 2021 - Coronavirus
(COVID-19) Update: February 9, 2021 |
| February 8, 2021 - FDA
Announces New Resource for Veterinarians and Pet Owners Interested
in Clinical Field Studies of Animal Cells, Tissues, and Cell- and
Tissue-Based Products |
| February 5, 2021 - Coronavirus
(COVID-19) Update: February 5, 2021 |
| February 5, 2021 - FDA
Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell
Lymphoma |
| February 5, 2021 - FDA
Authorizes Marketing of Novel Device to Reduce Snoring and Mild Obstructive
Sleep Apnea in Patients 18 Years and Older |
| February 4, 2021 - Coronavirus
(COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss
Janssen Biotech Inc.’s COVID-19 Vaccine Candidate |
| February 4, 2021 - Coronavirus
(COVID-19) Update: FDA Continues Important Work to Support Medical
Product Development to Address New Virus Variants |
| January 29, 2021 - Coronavirus
(COVID-19) Update: January 29, 2021 |
| January 26, 2021 - Coronavirus
(COVID-19) Update: January 26, 2021 |
| January 26, 2021 - Coronavirus
(COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand
Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative
and Potentially Dangerous Products into U.S., Protect U.S. Consumers |
| January 22, 2021 - Coronavirus
(COVID-19) Update: January 22, 2021 |
| January 21, 2021 - FDA
Approves First Extended-Release, Injectable Drug Regimen for Adults
Living with HIV |
| January 19, 2021 - Coronavirus
(COVID-19) Update: January 19, 2021 |
| January 19, 2021 - FDA
Marks Historic Public Health Milestone with Finalization of Two Key
Rules for Companies Seeking to Market New Tobacco Products |
| January 15, 2021 - Coronavirus
(COVID-19) Update: January 15, 2021 |
| January 15, 2021 - Federal
judge enters consent decree against Washington state juice processor |
| January 15, 2021 - FDA
Warns Firms to Remove Unauthorized E-liquid Products from Market in
First Letters Issued to Manufacturers that Did Not Submit Premarket
Applications by Deadline |
| January 14, 2021 - FDA
Grants First Conditional Approval Under Expanded Authority to Control
Seizures in Dogs with Idiopathic Epilepsy |
| January 13, 2021 - CBP,
FDA Seize Counterfeit, Unauthorized E-Cigarettes |
| January 12, 2021 - FDA
Releases Artificial Intelligence/Machine Learning Action Plan |
| January 11, 2021 - FDA
Conditionally Approves First Oral Tablet to Treat Lymphoma in Dogs |
| January 8, 2021 - Coronavirus
(COVID-19) Update: January 8, 2021 |
| January 8, 2021 - FDA
Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers
and Clinical Laboratory Staff |
| January 5, 2021 - Coronavirus
(COVID-19) Update: January 5, 2021 |
| January 4, 2021 - FDA
Statement on Following the Authorized Dosing Schedules for COVID-19
Vaccines |
| January 4, 2021 - FDA
Takes Steps to Provide Clarity on Developing New Drug Products in
the Age of Individualized Medicine |
For the most up to date FDA headlines, see the FDA
Medical Device News page.
| December 23, 2021
Reissued Emergency Use Authorizations
- DTPM
COVID-19 RT-PCR Test (Tide Laboratories, LLC)
- Simoa
SARS-CoV-2 N Protein Antigen Test (Quanterix Corporation)
- iHealth
COVID-19 Antigen Rapid Test (iHealth Labs, Inc.)
Updated Emergency Use Authorizations
- Access
SARS-CoV-2 IgG (Beckman Coulter, Inc.)
Non-Clinical
and Clinical Investigation of Devices Used for the Treatment of
Benign Prostatic Hyperplasia (BPH) - Guidance for Industry and Food
and Drug Administration Staff
|
|
December 22, 2021
SARS-CoV-2
Viral Mutations: Impact on COVID-19 Tests (Updated)
Assessing
the Credibility of Computational Modeling and Simulation in Medical
Device Submissions - Draft Guidance for Industry and Food and Drug
Administration Staff
Credibility
of Computational Models Program: Research on Computational Models
and Simulation Associated with Medical Devices (Updated)
Technical
Considerations for Medical Devices with Physiologic Closed-Loop
Control Technology - Draft Guidance for Industry and Food and Drug
Administration Staff
Arthroscopy
Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification
(510(k)) Submissions - Guidance for Industry and Food and Drug Administration
Staff
Transition
Plan for Medical Devices That Fall Within Enforcement Policies Issued
During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Draft Guidance for Industry and Food and Drug Administration Staff
Transition
Plan for Medical Devices Issued Emergency Use Authorizations (EUAs)
During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Draft Guidance for Industry and Food and Drug Administration Staff
Webinar
on Draft Guidances on Transition Plans for COVID-19 Related Medical
Devices - February 22, 2022
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- December 1, 2021 - Presentation and Transcript added
Digital
Health Technologies for Remote Data Acquisition in Clinical Investigations
Getinge’s
Maquet/Datascope IABP Devices: Update on Device Failure – Letter
to Health Care Providers
Cybersecurity
(Updated)
|
|
December 21, 2021
Webinar
- Hearing Aids and Personal Sound Amplification Products - Presentation,
Printable Slides, Transcript added
Webinar
- Content of Premarket Submissions for Device Software Functions,
Draft Guidance - Printable slides added
January
and February 2022 Dates Announced for the Virtual Town Hall Series
for Test Developers on Coronavirus (COVID-19)
|
|
December 20, 2021
New Emergency Use Authorizations
- BioCode
CoV-2 Flu Plus Assay (Applied BioCode, Inc.)
- UCSD
EXCITE COVID-19 Test (UCSD BCG EXCITE Lab)
Re-Issued Emergency Use Authorizations
- Quest
Diagnostics RC COVID-19+Flu RT-PCR (Quest Diagnostics Nichols Institute)
- Quest
Diagnostics Collection Kit for COVID (Quest Diagnostics Nichols
Institute)
- Quest
Diagnostics PF SARS-CoV-2 Assay(Quest Diagnostics Nichols Institute)
- Quest
Diagnostics RC SARS-CoV-2 Assay (Quest Diagnostics Nichols Institute)
- Quest
SARS-CoV-2 rRT-PCR (Quest Diagnostics Nichols Institute)
- cPass
SARS-CoV-2 Neutralization Antibody Detection Kit (GenScript USA
Inc.)
Revised Emergency Use Authorizations
- PKamp
Respiratory SARS-CoV-2 RT-PCR Panel 1 (PerkinElmer, Inc.)
- Sienna-Clarity
COVID-19 Antigen Rapid Test Cassette (Salofa Oy)
- Amazon
Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 (STS Lab Holdco
(a subsidiary of Amazon.com Services LLC)
- Amazon
Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test (STS Lab Holdco
(a subsidiary of Amazon.com Services LLC)
- Amazon
Multi-Target SARS-CoV-2 Real-Time RT-PCR Test STS Lab Holdco (a
subsidiary of Amazon.com Services LLC)
Updated Emergency Use Authorizations
- Simplexa
COVID-19 Direct assay (DiaSorin Molecular LLC)
-
ZEUS ELISA SARS-CoV-2 Total Antibody Test System (ZEUS Scientific,
Inc.)
- MAGLUMI
2019-nCoV IgM/IgG (Shenzhen New Industries Biomedical Engineering
Co., Ltd.)
- ACON
SARS-CoV-2 IgG/IgM Rapid Test (ACON Laboratories, Inc.)
- FREND
COVID-19 total Ab (NanoEntek America, Inc.)
- Access
SARS-CoV-2 IgM (Beckman Coulter, Inc.)
- Biohit
SARS-CoV-2 IgM/IgG Antibody Test Kit (Biohit Healthcare (Hefei)
Co. Ltd.)
- Babson
Diagnostics aC19G1 (Babson Diagnostics, Inc.)
Revoked Emergency Use Authorizations
- SARS-COV-2
R-GENE (BioMérieux SA)
- Atellica
IM SARS-CoV-2 IgG (COV2G)-(Siemens Healthcare Diagnostics Inc.)
- ADVIA
Centaur SARS-CoV-2 IgG (COV2G)-(Siemens Healthcare Diagnostics Inc.)
Consumer
Information on: Spatz3 Adjustable Balloon System - P190012
|
| December 17, 2021
Cybersecurity
Vulnerability with Apache Log4j
Ethylene
Oxide Sterilization for Medical Devices (Updated)
Voluntary
eSTAR Program (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Possible
False RPR Reactivity with BioPlex 2200 Syphilis Total & RPR
Test Kit Following a COVID-19 Vaccine - Letter to Clinical Laboratory
Staff and Health Care Providers
|
|
December 16, 2021
Class
I Recall: Getinge/Datascope/Maquet Recalls Cardiosave Hybrid and
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Due to Reports
of Fluid Leaks
Nucleic
Acid Based Tests (Updated)
24
Hour Summary and Presentations for December 10, 2021 Neurological
Devices Panel of the Medical Devices Advisory Committee Meeting
Federal
Register: Requests for Nominations: Voting Members on Public Advisory
Panels of the Medical Devices Advisory Committee
Federal
Register: Medical Devices: General and Plastic Surgery Devices;
Classification of the Manual Percutaneous Surgical Set Assembled
in the Abdomen
|
|
December 15, 2021
Referencing
the Definition of “Device” in the Federal Food, Drug,
and Cosmetic Act in Guidance, Regulatory Documents, Communications,
and Other Public Documents - Draft Guidance for Industry and Food
and Drug Administration Staff
Federal
Register: Guidance: Referencing the Definition of "Device"
in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory
Documents, Communications, and Other Public Documents
Federal
Register: Medical Devices: Neurological Devices; Classification
of the Traumatic Brain Injury Eye Movement Assessment Aid
SARS-CoV-2
Viral Mutations: Impact on COVID-19 Tests (Updated)
ASCA-Accredited
Testing Laboratories (Updated)
|
|
December 14, 2021
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200041
added)
Transcripts
for November 2-3, 2021 Circulatory System Devices Panel of the Medical
Devices Advisory Committee Meeting
Job
Opportunities at OSEL
Federal
Register: Orthopedic Devices; Classification of Spinal Spheres for
Use in Intervertebral Fusion Procedures
Federal
Register: Gastroenterology-Urology Devices; Classification of the
Endoscopic Transhepatic Venous Access Needle
Federal
Register: Gastroenterology-Urology Devices; Classification of the
Nonimplanted Nerve Stimulator for Functional Abdominal Pain Relief
|
|
December 13, 2021
Revised Emergency Use Authorizations
- PerkinElmer
New Coronavirus Nucleic Acid Detection Kit (PerkinElmer, Inc.)
- BD
Veritor System for Rapid Detection of SARS-CoV-2 (Becton, Dickinson
and Company (BD))
Updated Emergency Use Authorizations
- IDS
SARS-CoV-2 IgG (Immunodiagnostic Systems Ltd.)
Revoked Emergency Use Authorizations
- qSARS-CoV-2
IgG/IgM Rapid Test (Cellex Inc.)
|
| December 10, 2021
MedSun
Newsletter, December 2021
3D
Printing Medical Devices at the Point of Care: Discussion Paper
FDA
In Brief: FDA Publishes Discussion Paper and Seeks Public Input
on 3D Printing of Medical Devices at the Point of Care
Federal
Register: Gastroenterology-Urology Devices; Classification of the
Pressure Ulcer Management Tool
Federal
Register: Neurological Devices; Classification of the Temporary
Coil Embolization Assist Device
SARS-CoV-2
Viral Mutations: Impact on COVID-19 Tests (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
December 9, 2021
New Emergency Use Authorizations
- Nano-Check
COVID-19 Antigen Test (Nano-Ditech Corp.)
Updated Emergency Use Authorizations
- ZEUS
ELISA SARS-CoV-2 IgG Test System (ZEUS Scientific, Inc.)
Revoked
Emergency Use Authorizations
- BMC-CReM COVID-19 Test (Boston Medical Center)
- Akron Children's Hospital SARS-CoV-2 Assay (Akron Children’s
Hospital)
- BioGX SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson
& Company (BD))
Federal
Register: Gastroenterology-Urology Devices; Classification of the
Ingested, Transient, Space Occupying Device for Weight Management
and/or Weight Loss
Federal
Register: General and Plastic Surgery Devices; Classification of
the Negative Pressure Wound Therapy Device for Reduction of Wound
Complications
Federal
Register: Neurological Devices; Classification of the Transcutaneous
Electrical Nerve Stimulator for Attention Deficit Hyperactivity
Disorder
Federal
Register: Modifications to the List of Recognized Standards, Recognition
List Numbers: 056
SARS-CoV-2
Viral Mutations: Impact on COVID-19 Tests (Updated)
|
|
December 8, 2021
Materials
for December 10, 2021 Neurological Devices Panel of the Medical
Devices Advisory Committee Meeting
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - November 17, 2021
Radiological Health Program (Updated)
- FDA
eSubmitter (Updated)
- CDRH
eSubmitter Program (Updated)
Federal
Register: Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 056
|
|
December 7, 2021
SARS-CoV-2
Viral Mutations: Impact on COVID-19 Tests (Updated)
Industry
Discussions on MDUFA V Reauthorization (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries ( DEN200005
and DEN210012 added)
Federal
Register: Medical Devices; Exemption from Premarket Notification:
Powered Patient Transport, All Other Powered Patient Transport
|
|
December 6, 2021
Reissued Emergency Use Authorizations
- iHealth
COVID-19 Antigen Rapid Test (iHealth Labs, Inc.)
Revised Emergency Use Authorizations
- CareStart
COVID-19 Antigen test (Access Bio, Inc.)
Updated Emergency Use Authorizations
- GWU
SARS-CoV-2 RT-PCR Test (George Washington University Public Health
Laboratory)
- CareStart
COVID-19 Antigen Home Test (Access Bio, Inc.)
SARS-CoV-2
Viral Mutations: Impact on COVID-19 Tests (Updated)
Transcript
for Orthopedic Strategically Coordinated Registry Network Meeting
- 11/04/2021
|
| December 3, 2021
Class
I Recall: Arrow International Inc Recalls Arrow-Trerotola Over-The-Wire
PTD Kit Percutaneous Thrombolytic Device: 7Fr, Due to Risk of Separation
EUA
Authorized Serology Test Performance (Updated)
SARS-CoV-2
Viral Mutations: Impact on COVID-19 Tests (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
December 2, 2021
Consumer
Information on: Portico Transcatheter Aortic Valve Implantation
System - P190023
Paclitaxel-Coated
Balloons and Stents for Peripheral Arterial Disease
August
7, 2019 UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated
Balloons and Paclitaxel-Eluting Stents Potentially Associated with
Increased Mortality (Updated)
Request
for Nominations of Voting Members on a Public Advisory Committee;
National Mammography Quality Assurance Advisory Committee
Federal
Register: Request for Nominations: National Mammography Quality
Assurance Advisory Committee
|
|
December 1, 2021
New Emergency Use Authorizations
-
HealthPulse@home (Audere)
Re-Issued Emergency Use Authorizations
- LumiraDx
SARS-CoV-2 RNA STAR Complete (LumiraDx UK Ltd.)
- Kwokman
Diagnostics COVID-19 Home Collection Kit (Kwokman Diagnostics, LLC)
Updated Emergency Use Authorizations
- Aptima
SARS-CoV-2/Flu assay (Hologic, Inc.)
- MD
Anderson High-throughput SARS-CoV-2 RT-PCR Assay (University of
Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory)
- CareStart
COVID-19 Antigen Home Test (Access Bio, Inc.)
UPDATE:
Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’
Precice Devices - Letter to Health Care Providers
List
of Cleared or Approved Companion Diagnostic Devices (In Vitro and
Imaging Tools) (Updated)
Reclassification
(Updated)
MQSA
National Statistics as of December 1, 2021
Federal
Register: Anesthesiology Devices; Classification of the Isocapnic
Ventilation Device
Federal
Register: Gastroenterology-Urology Devices; Classification of the
Esophageal Tissue Characterization System
Federal
Register: Neurological Devices; Classification of the Conditioning
Tool for Eating Disorders
Federal
Register: Neurological Devices; Classification of the Trunk and
Limb Electrical Stimulator to Treat Headache
Federal
Register: Orthopedic Devices; Classification of the Intraoperative
Orthopedic Strain Sensor
|
| November 30, 2021
Cybersecurity
(Updated)
Federal
Register: Charter Renewal: Patient Engagement Advisory Committee
|
|
November 29, 2021
Transcript
for October 20, 2021 General and Plastic Surgery Devices Panel of
the Medical Devices Advisory Committee Meeting
Premarket
Submissions: Selecting and Preparing the Correct Submission (Updated)
Voluntary
eSTAR Program
Federal
Register: Requests for Nominations: Voting Members on a Public Advisory
Committee; Technical Electronic Product Radiation Safety Standards
Committee
|
| November 26, 2021
Transcript
added to Virtual Public Workshop - Transparency of Artificial Intelligence/Machine
Learning-enabled Medical Devices - October 14, 2021
|
|
November 24, 2021
Webinar
- De Novo Classification Process and FDA and Industry Actions: Effect
on FDA Review Clock and Goals, Final Guidances - December 14, 2021
|
|
November 23, 2021
Reissued Emergency Use Authorizations
- Abbott
RealTime SARS-CoV-2 assay (Abbott Molecular)
Updated Emergency Use Authorizations
- MiraDx
SARS-CoV-2 RT-PCR assay (MiraDx)
- Aeon
Global Health SARS-CoV-2 Assay (Aeon Global Health)
- BD
Veritor At-Home COVID-19 Test (Becton, Dickinson and Company (BD))
Medical
Device Shortages During the COVID-19 Public Health Emergency (Updated)
|
|
November 22, 2021
New Emergency Use Authorizations
- SCoV-2
Ag Detect Rapid Self-Test (InBios International Inc.)
Reissused Emergency Use Authorizations
- COVID-19
IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) (Healgen
Scientific LLC)
- GenBody
COVID-19 Ag (GenBody Inc.)
- INDICAID
COVID-19 Rapid Antigen Test (PHASE Scientific International, Ltd.)
-
BD Veritor At-Home COVID-19 Test (Becton, Dickinson and Company
(BD))
Revised Emergency Use Authorizations
- GENETWORx
Covid-19 Nasal Swab Test (RCA Laboratory Services LLC dba GENETWORx)
- SGTi-flex
COVID-19 IgG (Sugentech, Inc.)
- VITROS
Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack (Ortho
Clinical Diagnostics, Inc.)
Updated Emergency Use Authorizations
- Personal
Protective Equipment EUAs (Update to Appendix A)
- CareStart
COVID-19 Antigen Home Test (Access Bio, Inc.)
Federal
Register: General and Plastic Surgery Devices; Classification of
the General Laparoscopic Power Morcellation Containment System
|
| November 19, 2021
Safely
Using Sharps (Needles and Syringes) at Home, at Work and on Travel
(Updated)
Reclassification
(Updated)
FDA
In Brief: FDA Issues Final Orders Reclassifying Certain Hepatitis
C Diagnostic Tests from Class III to Class II
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Federal
Register: Effective Date of Requirement for Premarket Approval for
Blood Lancets
Federal
Register: General and Plastic Surgery Devices; Reclassification
of Blood Lancets
Federal
Register: Reclassification of Certain Hepatitis C Virus Antibody
Assay Devices, Renamed to Hepatitis C Virus Antibody Tests
Federal
Register: Reclassification of Nucleic Acid-Based Hepatitis C Virus
Ribonucleic Acid Assay Devices, Renamed to Nucleic Acid-Based Hepatitis
C Virus Ribonucleic Acid Tests
Federal
Register: Administrative Detention and Banned Medical Devices
|
|
November 18, 2021
Potential
for Medication Overdose with ENFit Low Dose Tip Syringe: FDA Safety
Communication (Updated)
Federal
Register: Guidance: Website Location of Center for Devices and Radiological
Health Fiscal Year 2022
|
|
November 17, 2021
MDUFA
IV Performance Report - 4th Quarter FY2021
Leadless
Pacing Systems: Risk of Major Complications Related to Cardiac Perforation
During Implantation - Letter to Health Care Providers
|
|
November 16, 2021
Medical
Device Development Tools (MDDT) (Updated)
|
|
November 15, 2021
Reissued Emergency Use Authorizations
- Verily
COVID-19 RT-PCR Test (Verily Life Sciences)
- cPass
SARS-CoV-2 Neutralization Antibody Detection Kit (GenScript USA
Inc.)
Policy
for Coronavirus Disease-2019 Tests During the Public Health Emergency
(Revised) - Guidance for Developers and Food and Drug Administration
Staff
Enforcement
Policy for Viral Transport Media During the Coronavirus Disease
2019 (COVID-19) Public Health Emergency (Revised) - Guidance for
Commercial Manufacturers, Clinical Laboratories, and Food and Drug
Administration Staff
Coronavirus
(COVID-19) and Medical Devices (Updated)
FAQs
on Testing for SARS-CoV-2 (Updated)
Reissued
the EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed
And Performed By Laboratories Certified Under CLIA To Perform High
Complexity Tests
Umbrella
EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing
FDA
News Release: Coronavirus (COVID-19) Update: FDA Updates Test Policies
to Help to Ensure Accuracy and Reliability of Tests and Increase
Access to At-Home Tests
Consumer
Information on: Vercise™ PC, Vercise Gevia™ and Vercise
Genus™ Deep Brain Stimulation (DBS) System - P150031/S040
Consumer
Information on: Ki-67 IHC MIB-1 pharmDx (Dako Omnis) - P210026
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN210006
added)
|
| November 12, 2021
Update:
Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines
Recalled Due to Potential Health Risks: FDA Safety Communication
Philips
Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked
Questions (Updated)
|
|
November 10, 2021
New Emergency Use Authorizations
- Revogene
SARS-CoV-2 (Meridian Bioscience, Inc.)
Reissued Emergency Use Authorizations
- QuickVue
SARS Antigen Test (Quidel Corporation)
Revised Emergency Use Authorizations
- Orawell
IgM/IgG Rapid Test (Jiangsu Well Biotech Co., Ltd)
Updated Emergency Use Authorizations
- Talis
One COVID-19 Test System (Talis Biomedical Corporation)
- Amplitude
Solution with the TaqPath COVID-19 High-Throughput Combo Kit (Thermo
Fisher Scientific Inc.)
- Flowflex
COVID-19 Antigen Home Test (ACON Laboratories, Inc)
Consumer
Information on: ConMed PadPro Multifunction Electrodes, ConMed PadPro
Multifunction Electrode Adapters – P200004
Ellume
Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2
Test Results
Potential
for False Positive Results with Certain Lots of Ellume COVID-19
Home Tests Due to a Manufacturing Issue: FDA Safety (Updated)
Activities
to Support Medical Device Innovators (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200033
added)
|
|
November 9, 2021
Molecular
and Antigen Home Use Test Template (Updated)
24
Hour Summaries posted for November 2-3, 2021 Circulatory System
Devices Panel of the Medical Devices Advisory Committee Meeting
Class
I Recall: Aligned Medical Solutions Doing Business as Windstone
Medical Packaging, Inc. Recalls Custom Convenience Kits Due to Cardinal
Health Monoject Flush Prefilled Syringe (0.9% Sodium Chloride) Plunger
Defect
|
|
November 8, 2021
New Emergency Use Authorizations
- Talis
One COVID-19 Test System (Talis Biomedical Corporation)
Reissued Emergency Use Authorizations
- Alinity
m SARS-CoV-2 assay (Abbott Molecular Inc.)
- BinaxNOW
COVID-19 Antigen Self Test (Abbott Diagnostics Scarborough, Inc.)
Updated Emergency Use Authorizations
- LetsGetChecked
Coronavirus (COVID-19) Test (LetsGetChecked, Inc.)
- PKamp
Respiratory SARS-CoV-2 RT-PCR Panel 1 (PerkinElmer, Inc.)
- SGTi-flex
COVID-19 IgG (Sugentech, Inc.)
- MidaSpot
COVID-19 Antibody Combo Detection Kit (Nirmidas Biotech, Inc.)
Consumer
Information on: Organ Care System (OCS) Liver – P200031
Table
of Pharmacogenetic Associations (Updated)
|
|
November 5, 2021
New Emergency Use Authorizations
- iHealth
COVID-19 Antigen Rapid Test
Updated Emergency Use Authorizations
- Personal
Protective Equipment EUAs (Update to Appendix A)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190028
and DEN200040 added)
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - October 20, 2021
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests That Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
November 4, 2021
Cybersecurity
(Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN180007
added)
|
|
November 3, 2021
Content
of Premarket Submissions for Device Software Functions - Draft Guidance
for Industry and Food and Drug Administration Staff
Webinar
- Draft Guidance: Content of Premarket Submissions for Device Software
Functions - December 16, 2021
Federal
Register: Content of Premarket Submissions for Device Software Functions
|
|
November 2, 2021
Nucleic
Acid Based Tests (Updated)
|
|
November 1, 2021
Updated Emergency Use Authorizations
- Detect
Covid-19 Test (Detect, Inc.)
- Boston
Heart COVID-19 RT-PCR Test (Boston Heart Diagnostics)
Reissued Emergency Use Authorizations
- Aptima
SARS-CoV-2 assay (Hologic, Inc.)
- Aptima
SARS-CoV-2/Flu assay (Hologic, Inc.)
- SalivaDirect
(Yale School of Public Health, Department of Epidemiology of Microbial
Diseases)
- SalivaDirect
for use with DTC Kits (Yale School of Public Health, Department
of Epidemiology of Microbial Diseases)
- LumiraDx
SARS-CoV-2 Ag Test (LumiraDx UK Ltd.)
- Status
COVID-19/Flu (Princeton BioMeditech Corp.)
- InteliSwab
COVID-19 Rapid Test (OraSure Technologies, Inc.)
|
| October 29, 2021
Medical
Gloves for COVID-19 (Updated)
Materials
posted for November 2-3, 2021 Circulatory System Devices Panel of
the Medical Devices Advisory Committee Meeting
Class
I Recall: Zimmer Biomet Recalls ROSA One 3.1 Brain Application Due
to Error in Software
Class
I Recall: Datascope/Getinge/Maquet Recalls Cardiosave Hybrid/Rescue
Intra-Aortic Balloon Pump Battery Packs Due to Risk of Battery Failure
Dental
Implants: What You Should Know
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests That Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
October 28, 2021
New Emergency Use Authorizations
- Detect
Covid-19 Home Test (Detect, Inc.)
Updated Emergency Use Authorizations
- Personal
Protective Equipment EUAs (Update to Appendix A)
|
|
October 27, 2021
Good
Machine Learning Practice for Medical Device Development: Guiding
Principles
Breast
Implant Postmarket Safety Information
Breast
Implants (Updated)
Labeling
for Approved Breast Implants (Updated)
FDA
News Release: FDA Strengthens Safety Requirements and Updates Study
Results for Breast Implants
Federal
Register: Revocation of Authorization of Emergency Use of an In
Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19;
Availability
Federal
Register: Authorization of Emergency Use of Certain Medical Devices
During COVID-19; Availability
|
|
October 26, 2021
CDRH
Proposed Guidances for Fiscal Year 2022 (FY2022)
CDRH
Proposed Guidance Development (Updated)
Federal
Register: Guidance: Website Location of Center for Devices and Radiological
Health Fiscal Year 2022
Meeting
Notice: December 10, 2021 Neurological Devices Panel of the Medical
Devices Advisory Committee
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- November 17, December 1, and December 15, 2021 (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
October 25, 2021
New Emergency Use Authorizations
- Celltrion
DiaTrust COVID-19 Ag Home Test (Celltrion USA, Inc.)
- QuickVue
At-Home OTC COVID-19 Test (Quidel Corporation)
- SCoV-2
Detect Neutralizing Ab ELISA (InBios International, Inc.)
Reissued Emergency Use Authorizations
- SelfCheck
cobas SARS-CoV-2 Assay (G Cleveland Clinic Robert J. Tomsich Pathology
and Laboratory Medicine Institute)
Updated Emergency Use Authorizations
- cobas
SARS-CoV-2 (Roche Molecular Systems, Inc.)
- cobas
SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.)
- TaqPath
COVID-19 Fast PCR Combo Kit 2.0 (Life Technologies Corporation (a
part of Thermo Fisher Scientific Inc.)
- Xpert
Xpress CoV-2/Flu/RSV plus (Cepheid)
In
Vitro Diagnostics EUAs (Updated)
Decorative
Contact Lenses for Halloween and More (Updated)
Endometrial
Ablation for Heavy Menstrual Bleeding
Federal
Register: Neurological Devices Panel of the Medical Devices Advisory
Committee
|
| October 22, 2021
24
Hour Summary for October 20, 2021 General and Plastic Surgery Devices
Panel of the Medical Devices Advisory Committee Meeting
Transcript
and Summary Minutes for July 14, 2021 Gastroenterology and Urology
Devices Panel of the Medical Devices Advisory Committee Meeting
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests That Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
October 21, 2021
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN210005
added)
|
|
October 20, 2021
Updated Emergency Use Authorizations
- Flowflex
COVID-19 Antigen Home Test (ACON Laboratories)
- QuickVue
At-Home OTC COVID-19 Test (Quidel Corporation)
- Zika
Virus Detection by RT-PCR Test (ARUP Laboratories)
- Zika
MAC-ELISA (CDC)
- Zika
ELITe MGB Kit U.S. (ELITechGroup Inc. Molecular Diagnostics)
Medical
Device Reporting (MDR): How to Report Medical Device Problems (Updated)
Presentation
Slides added to Virtual Public Workshop - Transparency of Artificial
Intelligence/Machine Learning-enabled Medical Devices - October
14, 2021
|
|
October 19, 2021
Regulatory
Requirements for Hearing Aid Devices and Personal Sound Amplification
Products - Draft Guidance for Industry and Food and Drug Administration
Staff
Hearing
Aids (Updated)
Other
Hearing Devices and Products (Updated)
Webinar
on Proposed Rule for Establishing Over-the-Counter Hearing Aids
and Draft Guidance for Regulatory Requirements for Hearing Aid Devices
and Personal Sound Amplification Products
Federal
Register: Regulatory Requirements for Hearing Aid Devices and Personal
Sound Amplification Products; Availability
Federal
Register: Ear, Nose, and Throat Devices; Establishing Over-the-Counter
Hearing Aids
|
|
October 18, 2021
New Emergency Use Authorizations
- CovidNow
SARS-CoV-2 Assay (LMSI, LLC (dba Lighthouse Lab Services))
Reissued Emergency Use Authorizations
- Gravity
Diagnostics SARS-CoV-2 RT-PCR (Gravity Diagnostics, LLC)
- Gravity
Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits (Gravity Diagnostics,
LLC)
Updated Emergency Use Authorizations
- Flowflex
COVID-19 Antigen Home Test (ACON Laboratories, Inc)
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- October 20, 2021
Studies
Using Leftover, Deidentified Human Specimens Require IRB Review
– Letter to Industry
Materials
for October 20, 2021 General and Plastic Surgery Devices Panel of
the Medical Devices Advisory Committee Meeting
|
| October 14, 2021
New Emergency Use Authorizations
- SPERA
COVID-19 Ag Test (Xtrava Health)
Reissued Emergency Use Authorizations
- TaqPath
COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
- Amplitude
Solution with the TaqPath COVID-19 High-Throughput Combo Kit (Thermo
Fisher Scientific, Inc.)
Updated Emergency Use Authorizations
- Quest
Diagnostics PF SARS-CoV-2 Assay (Quest Diagnostics Infectious Disease,
Inc.)
- BinaxNOW
COVID-19 Antigen Self Test (Abbott Diagnostics Scarborough, Inc.)
Class
I Recall: Abbott Molecular, Inc. Recalls Alinity m SARS-CoV-2 AMP
Kit and Alinity m Resp-4-Plex AMP Kit for Potential False Positive
SARS-CoV-2 Test Results
Potential
for False Positive Results with Abbott Molecular Inc. Alinity m
SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits - Letter to Clinical
Laboratory Staff and Health Care Providers (Updated)
Video
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - October 6, 2021
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests That Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
October 13, 2021
Select
Updates for Unique Device Identification: Policy Regarding Global
Unique Device Identification Database Requirements for Certain Devices
UDI
Rule and Guidances, Training, Resources, and Dockets (Updated)
GUDID
Guidance (Updated)
Unique
Device Identification System (UDI System) (Updated)
UPDATE:
Potential Risk of Infection When Using Heater-Cooler Devices –
Letter to Health Care Providers
FDA's
Ongoing Evaluation and Continued Monitoring of Reports of Nontuberculous
Mycobacteria Infections Associated with Heater-Cooler Devices (Updated)
What
Is a Heater-Cooler Device? (Updated)
Third
Party Performance Report - FY21, Q4
Federal
Register: Select Updates for Unique Device Identification: Policy
Regarding Global Unique Device Identification Database Requirements
for Certain Devices
|
|
October 12, 2021
New Emergency Use Authorization
- Cleveland
Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute
- PerkinElmer,
Inc.
- Quest Diagnostics Infectious Disease, Inc.
- - Quest
Diagnostics Collection Kit for COVID-19 10/08/2021
- Emergency
Use Authorization of COVID-19 Tests: Independent Assessment of the
FDA’s Response
Updated Emergency Use Authorization
- EUROIMMUN
US, Inc.
- DiaSorin
Inc.
Re-issued Emergency Use Authorization
- Quest Diagnostics Infectious Disease, Inc.
- - Quest
Diagnostics HA SARS-CoV-2 Assay
- - Quest
Diagnostics RC SARS-CoV-2 Assay
- - Quest
Diagnostics PF SARS-CoV-2 Assay
24
Hour Summary for October 6, 2021 Patient Engagement Advisory Committee
Meeting
Potential
for Medication Overdose with ENFit Low Dose Tip Syringe: FDA Safety
Communication
|
| October 8, 2021
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests That Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
Video
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - September 22, 2021
Do
Not Use Needle-Free Devices for Injection of Dermal Fillers –
FDA Safety Communication
Dermal
Fillers (Soft Tissue Fillers) (Updated)
Reclassification
(Updated)
|
|
October 7, 2021
Surgical
Staplers and Staples for Internal Use - Labeling Recommendations
- Guidance for Industry and Food and Drug Administration Staff
UPDATE:
Safe Use of Surgical Staplers and Staples - Letter to Health Care
Providers
Surgical
Staplers and Staples (Updated)
Federal
Register: General and Plastic Surgery Devices: Reclassification
of Certain Surgical Staplers
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Medical Device Labeling Regulations
Federal
Register: Guidance: Surgical Staplers and Staples for Internal Use--Labeling
Recommendations
First
Database of Tumor Mutations Recognized by the FDA as a Scientifically
Valid Source for Test Developers
|
|
October 6, 2021
Class
1 Recall: DeRoyal Recalls Procedure Packs Containing Smiths Medical
NORMOFLO Irrigation Warming Set
In
Vitro Diagnostics EUAs (Updated)
Class
I Recall: Imperative Care Inc. Recalls ZOOM 71 Reperfusion Catheter
Due to Risk of Breaks During Use
|
|
October 5, 2021
New Emergency Use Authorization
- Laboratory
Corporation of America (Labcorp)
- EUROIMMUN
US, Inc.
Updated
- Abbott
Laboratories Inc.
- Siemens
Healthcare Diagnostics Inc.
- Zika
Virus Detection by RT-PCR Test (ARUP Laboratories)
- Zika
MAC-ELISA (CDC)
- Zika
ELITe MGB Kit U.S. (ELITechGroup Inc. Molecular Diagnostics)
- Zika
Virus Real-time RT-PCR Test (Viracor Eurofins)
Cybersecurity
Awareness Month at the FDA
Cybersecurity
(Updated)
Job
Opportunities at OSEL (Updated)
Class
I Recall: Medtronic Recalls MiniMed Insulin Pumps for Incorrect
Insulin Dosing (Updated)
Video
added to Virtual Town Hall Series - Coronavirus (COVID-19) Test
Development and Validation - August 4, 2021
Video
added to Virtual Town Hall Series - Coronavirus (COVID-19) Test
Development and Validation - August 11, 2021
Federal
Register: Guidance Documents Related to Coronavirus Disease 2019
Potential
for False Positive Results with Certain Lots of Ellume COVID-19
Home Tests Due to a Manufacturing Issue: FDA Safety Communication
Class
I Recall: Medtronic Recalls Remote Controllers Used with Paradigm
and 508 MiniMed Insulin Pumps for Potential Cybersecurity Risks
|
|
October 4, 2021
Consumer Information on:
- RADIESSE
(+) Lidocaine Injectable Implant - P050052/S129
- Oncomine
Dx Target Test - P160045/S028
- Amplatzer
Amulet Left Atrial Appendage Occluder - P200049
Virtual
Public Meeting - Orthopedic Strategically Coordinated Registry Network
Meeting - November 4, 2021
FDA
and Industry Actions on De Novo Classification Requests: Effect
on FDA Review Clock and Goals - Guidance for Industry and Food and
Drug Administration Staff
De
Novo Classification Process (Evaluation of Automatic Class III Designation)
- Guidance for Industry and Food and Drug Administration Staff
User
Fees and Refunds for De Novo Classification Requests - Guidance
for Industry and Food and Drug Administration Staff
Acceptance
Review for De Novo Classification Requests - Guidance for Industry
and Food and Drug Administration Staff
De
Novo Classification Request (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190055
added)
Federal
Register: Medical Device De Novo Classification Process
New Emergency Use Authorization
- ACON
Laboratories, Inc.
|
| October 1, 2021
MQSA
National Statistics
Risk
of Device Component Breaking in Patients with Stryker’s STAR
Ankle: FDA Safety Communication (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests That Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
| September 30, 2021
Device
Registration and Listing (Updated)
Video
added to Virtual Town Hall Series - Coronavirus (COVID-19) Test
Development and Validation - August 18, 2021
Video
added to Virtual Town Hall Series - Coronavirus (COVID-19) Test
Development and Validation - August 25, 2021
MDUFA
IV Independent Assessment Report
|
|
September 29, 2021
Essure
Permanent Birth Control (Updated)
FDA
Activities Related to Essure (Updated)
Problems
Reported with Essure (Updated)
Risk
of Exposure to Unsafe Levels of Radiation with Safe-T-Lite UV WAND:
FDA Safety Communication
Transcript
added to Virtual Town Hall Series - Coronavirus (COVID-19) Test
Development and Validation - August 18, 2021
Transcript
added to Virtual Town Hall Series - Coronavirus (COVID-19) Test
Development and Validation - August 25, 2021
|
|
September 28, 2021
All
Ultrasound Gels and Lotions Manufactured by Eco-Med Pharmaceutical,
Inc. Recalled Due to Risk of Bacteria Contamination (Updated)
Electronic
Submission Template for Medical Device 510(k) Submissions - Draft
Guidance for Industry and Food and Drug Administration Staff
510(k)
Program Pilots (Updated)
Federal
Register: Electronic Submission Template for Medical Device 510(k)
Submissions
Revocation - Emergency Use Authorization
- Life
Technologies Corporation (a part of Thermo Fisher Scientific Inc.)
Magellan
Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra
Blood Lead Tests Due to Risk of Falsely Low Results (Updated)
Materials
posted for October 6, 2021 Patient Engagement Advisory Committee
Meeting
CDRH
Petitions (Updated)
|
|
September 27, 2021
New Emergency Use Authorization
- ANP
Technologies, Inc.
Re-issued - Emergency Use Authorization
- GenBody
Inc.
Updated - Emergency Use Authorizations
- Thermo
Fisher Scientific
- Quanterix
Corporation
Materials
posted for October 6, 2021 Patient Engagement Advisory Committee
Meeting
Left
Atrial Appendage Occlusion (LAAO) Devices Potentially Associated
with Procedural Outcome Differences Between Women and Men –
Letter to Health Care Providers
Good
Clinical Practice (GCP) Requirements for Data Submitted from Clinical
Investigations for In Vitro Diagnostic (IVD) Device Premarket Submissions
|
| September 24, 2021
New Emergency Use Authorization - Viral Mutation Revision Letter
- In
Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2
- In
Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2
- In
Vitro Diagnostics EUAs - Serology and Other Adaptive Immune Response
Tests for SARS-CoV-2
- SARS-CoV-2
Viral Mutations: Impact on COVID-19 Tests
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests That Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
September 23, 2021
New Emergency Use Authorization
- Life
Sciences Testing Center COVID-19 Test
Updated Emergency Use Authorizations
- Kaiser
Permanente High Throughput SARS-CoV-2 Assay
- Alimetrix
SARS-CoV-2 RT-PCR Assay
- BD
MAX COVID-19 ASSAY (Authorized by HHS/OASH)
- ADEXUSDx
COVID-19 Test
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200080
added)
Class
I Recall: Armstrong Medical Limited Recalls AMSORB PLUS PREFILLED
G-CAN 1.0L Due to Reduced Gas Flow to Patients During Anesthesia
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- October 6, 2021
Federal
Register: Revocation of Three Authorizations of Emergency Use of
In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19;
Availability
|
|
September 22, 2021
Artificial
Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
Medical
Device Material Safety Summaries: ECRI Reports
FDA
In Brief: FDA Publishes Material Safety Data to Promote Safer, More
Effective Medical Devices
Class
I Recall: Cordis Recalls Super Torque MB Angiographic Catheter with
Radiopaque Marker Bands Due to Potential for Marker Bands to Move
or Dislodge
|
|
September 21, 2021
Re-Issued Emergency Use Authorization
- LetsGetChecked,
Inc.
- Color
Health, Inc
Consumer
Information on: VENTANA MMR RxDx Panel - P210001
Virtual
Public Workshop - Orthopedic Device-Related Infections II Workshop
- December 3, 2021
Consumer
Information on: RelayPro Thoracic Stent-Graft System - P200045
|
|
September 20, 2021
Class
I Recall: Medtronic (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular)
Recalls Pipeline Flex Embolization Devices for Risk of Delivery
System Fractures During Placement, Retrieval, or Movement of Device
|
| September 17, 2021
Updated Emergency Use Authorizations
- Appendix
A: Authorized Surgical Masks
Potential
for False Positive Results with Abbott Molecular Inc. Alinity m
SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits - Letter to Clinical
Laboratory Staff and Health Care Providers
COVID-19
Tests and Collection Kits Authorized by the FDA: Infographic (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests That Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
September 16, 2021
Unique
Device Identification System (UDI System) (Updated)
|
|
September 15, 2021
New Emergency Use Authorizations
- Cepheid
Reissued Emergency Use Authorizations
- Quanterix
Corporation
- Siemens
Healthcare Diagnostics, Inc
Updated Emergency Use Authorizations
- Access
Bio, Inc
- Siemens
Healthcare Diagnostics, Inc
Stakeholder
Consultation Meetings - Medical Device User Fee Amendments 2023
(MDUFA V) (Updated)
Class
I Recall: Smiths Medical Recalls NORMOFLO Irrigation Fluid Warmers
and Warming Sets Due to the Possibility of Harmful Levels of Aluminum
Leaching into the Fluid Path of the Warmers
Potential
Risk of Aluminum Leaching with Use of Certain Fluid Warmer Devices
- Letter to Health Care Providers
Enforcement
Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical
Masks, and Respirators During the Coronavirus Disease (COVID-19)
Public Health Emergency (Revised) - Guidance for Industry and Food
and Drug Administration Staff
Face
Masks, Barrier Face Coverings, Surgical Masks, and Respirators for
COVID-19 (Updated)
N95
Respirators, Surgical Masks, Face Masks, and Barrier Face Coverings
(Updated)
|
|
September 13, 2021
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200030
added)
|
| September 10, 2021
Reissued Emergency Use Authorizations
- Assurance
Scientific Laboratories
- Ortho-Clinical
Diagnostics, Inc.
Updated Emergency Use Authorizations
- GK
Pharmaceuticals Contract Manufacturing Operations
- Access
Genetics, LLC
- Phosphorus
Diagnostics LLC
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- September 22, 2021
Two
New CDRH Learn Modules: ¿Cómo se clasifica mi dispositivo
médico? and Importación de Dispositivos Médicos
a los Estados Unidos
Certain
Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled
Due to Potential Health Risks: FDA Safety Communication (Updated)
Philips
Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked
Questions (Updated)
Medical
Device Shortages During the COVID-19 Public Health Emergency (Updated)
Class
I Recall: All Ultrasound Gels and Lotions Manufactured by Eco-Med
Pharmaceutical, Inc. Recalled Due to Risk of Bacteria Contamination
Stop
Using All Eco-Med Ultrasound Gels and Lotions Due to Risk of Bacterial
Contamination - Letter to Health Care Providers (Updated)
ASCA-Accredited
Testing Laboratories (Updated)
Mammography
Facility Adverse Event and Action Report - September 13, 2021: Hoffman
Medical Center, a/k/a Hoffman MRI, f/k/a Hope Imaging and Medical
Center, Inc.
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests That Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
September 9, 2021
The
CDC & FDA Antibiotic Resistance Isolate Bank (Updated)
Consumer
Information on: therascreen KRAS RGQ PCR Kit - P110027/S012
N95
Respirators, Surgical Masks, and Face Masks (Updated)
|
|
September 8, 2021
Revised Emergency Use Authorizations for Face Shields and Other
Barriers
- Individual
Biocontainment Unit (IBU)
MDSAP
AU P0037.001 Guidelines on the use of GHTF/SG3/N19:2012 for MDSAP
purposes
CDRH's
Customer Service Rating
|
|
September 7, 2021
Reissued - Emergency Use Authorization
- Color
Health, Inc. (2 reissued)
- InBios
International, Inc.
|
|
September 3, 2021
Reissued Emergency Use Authorizations
- BioFire
Respiratory Panel 2.1-EZ (RP2.1-EZ)
- Visby
Medical COVID-19
- TaqPath
COVID-19 RNase P Combo Kit 2.0
- Celltrion
DiaTrust COVID-19 Ag Rapid Test
- T-Detect
COVID Test
- AdviseDx
SARS-CoV-2 IgM
- Atellica
IM SARS-CoV-2 IgG (sCOVG)
Updated Emergency Use Authorizations
- cobas
SARS-CoV-2
- Assurance
SARS-CoV-2 Panel
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests That Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
Federal
Register: Reclassification Petitions for Medical Devices
|
|
September 2, 2021
August
2021 PMA Approval List
MedSun
Newsletter, September 2021
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN210013,
DEN210003, DEN200064 and DEN190056 added)
|
|
September 1, 2021
#177,
MedSun Newsletter, September 2021
Transcript
added to Virtual Town Hall Series - Coronavirus (COVID-19) Test
Development and Validation - August 4, 2021
Transcript
added to Virtual Town Hall Series - Coronavirus (COVID-19) Test
Development and Validation - August 11, 2021
MQSA
National Statistics (Updated)
|
| August 31, 2021
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- September 8, 2021
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests That Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
August 30, 2021
New Emergency Use Authorizations
- Yale School of Public Health, Department of Epidemiology of Microbial
Diseases
- - SalivaDirect
for use with DTC Kits
- - SalivaDirect
DTC Saliva Collection Kit
Reissued Emergency Use Authorizations
- BioFire
Defense, LLC
- Abbott
Diagnostics Scarborough, Inc.
Updated Emergency Use Authorizations
- TBG
Biotechnology Corp
- GK
Pharmaceuticals Contract Manufacturing Operations
- Becton,
Dickinson and Company (BD)
Tracking
Your Premarket Submission’s Progress (Progress Tracker)
|
| August 27, 2021
New Emergency Use Authorization
- Empire
City Laboratories COVID Test System
- Empire
City Laboratories COVID Test System-1
- InBios
International, Inc
Updated Emergency Use Authorization
- The
Mount Sinai Hospital, Center for Clinical Laboratories
Reissued Emergency Use Authorization
- Gencurix,
Inc
- University
of Illinois Office of the Vice President for Economic Development
and Innovation
FAQs
on Viral Transport Media During COVID-19 (Updated)
Denture
Base Resins - Performance Criteria for Safety and Performance Based
Pathway - Draft Guidance for Industry and Food and Drug Administration
Staff
Facet
Screw Systems - Performance Criteria for Safety and Performance
Based Pathway - Draft Guidance for Industry and Food and Drug Administration
Staff
Federal
Register: Safety and Performance Based Pathway Device-Specific Guidances
|
|
August 26, 2021
New Emergency Use Authorization
- Mount
Sinai Hospital, Center for Clinical Laboratories
- Becton,
Dickinson and Company (BD)
Updated Emergency Use Authorization
- CareStart
COVID-19 Antigen Home Test
- Sugentech,
Inc.
Meeting
Notice: October 20, 2021 General and Plastic Surgery Devices Panel
of the Medical Devices Advisory Committee
Meeting
Notice: November 2-3, 2021 Circulatory System Devices Panel of the
Medical Devices Advisory Committee
Mammography
Problems at Madison Avenue Radiology Center 190th Broadway in New
York, New York: FDA Safety Communication
Consumer
Information on: Guardant360 CDx – P200010/S002
Consumer
Information on: ASSURE Wearable Cardioverter Defibrillator System
Kit (P/N 80014-001), Monitor (P/N 80008-003), Therapy Cable (P/N
80004-003), Garment Style A (P/N 80015-XXX*) and Style B (P/N 80016-XXX*),
Rechargeable Battery (P/N 3322882-005), Carry Pack (3326503-003),
Battery Charger (3326633-004), Tablet (P/N 80041-001) – P200037
|
|
August 25, 2021
Stop
Using Certain N95 Respirators Manufactured by Shanghai Dasheng -
Letter to Health Care Providers
Over-the-Counter
(OTC) Medical Devices: Considerations for Device Manufacturers
|
|
August 24, 2021
Class
I Recall: Bio-Medical Equipment Service Co. Recalls Alaris Infusion
Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel
Repair Posts
Virtual
Public Workshop – Transparency of Artificial Intelligence/Machine
Learning-enabled Medical Devices - October 14, 2021
Medical
Device Development Tools (MDDT) (Updated)
|
|
August 23, 2021
Class
I Recall: Cardinal Health Recalls Monoject Saline Flush Prefilled
Syringes for Risk of Air Re-entering Syringe Leading to Air Embolism
ASCA-Accredited
Testing Laboratories (Updated)
|
| August 20, 2021
Class
I Recall: Cardinal Health Recalls Argyle UVC Insertion Tray Due
to Missing Instructions for Use for the Safety Scalpel N11
UPDATE:
Caution with Robotically-Assisted Surgical Devices in Mastectomy:
FDA Safety Communication
Reissued Emergency Use Authorization
- BioCore
2019-nCoV Real Time PCR Kit (INVITES BIOCORE CO., LTD.)
- Alinity
m SARS-CoV-2 assay (Abbott Molecular Inc.)
- Infinity
BiologiX TaqPath SARS-CoV-2 Assay (Infinity BiologiX LLC)
- IntelliPlex
SARS-CoV-2 Detection Kit (PlexBio Co., Ltd.)
- Access
SARS-CoV-2 IgG II (Beckman Coulter, Inc.)
Updated Emergency Use Authorization
- Amazon
Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test (STS Lab Holdco
(a subsidiary of Amazon.com Services LLC)
- BD
Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site) (Becton,
Dickinson and Company)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests That Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
August 18, 2021
510(k)
Third Party Performance Metrics and Accreditation Status (Updated)
EUA
Authorized Serology Test Performance (Updated)
MQSA
Inspection Information Related to COVID-19 (Updated)
Stop
Using All Eco-Med Ultrasound Gels and Lotions Due to Risk of Bacterial
Contamination – Letter to Health Care Providers
|
|
August 17, 2021
Updated
MDDT Proposal Phase Template
Consumer
Information on: Senza Spinal Cord Stimulation System – P130022/S039
Cybersecurity
(Updated)
|
|
August 16, 2021
New Emergency Authorizations
- Kwokman
Diagnostics COVID-19 Home Collection Kit (Kwokman Diagnostics, LLC)
Reissued Emergency Authorizations
- Gravity
Diagnostics SARS-CoV-2 RT-PCR Assay (Gravity Diagnostics, LLC)
Revised Emergency Use Authorizations
- binx
health At-Home Nasal Swab COVID-19 Sample Collection Kit (binx health,
Inc.)
Updated Emergency Use Authorizations
- CareStart
COVID-19 IgM (Access Bio, Inc.)
- CentoSure
SARS-CoV-2 RT-PCR Assay (CENTOGENE US, LLC)
- CentoFast-SARS-CoV-2
RT-PCR Assay (CENTOGENE US, LLC)
Consumer
Information on: Neuro Cochlear Implant System – P200021
Consumer
Information on: XIENCE Alpine Everolimus Eluting Coronary Stent
Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting
Coronary Stent Systems (XIENCE Sierra EECSS), XIENCE Skypoint Everolimus
Eluting Coronary Stent Systems (XIENCE Skypoint EECSS) – P110019/S115
Consumer
Information on: Resolute Onyx Zotarolimus-Eluting Coronary Stent
System – P160043/S034
Pelvic
Organ Prolapse (POP): Surgical Mesh Considerations and Recommendations
(New)
FDA's
Activities: Urogynecologic Surgical Mesh (Updated)
Urogynecologic
Surgical Mesh Implants (Updated)
Use
Purple Bracelets or Wristbands Only for Do Not Resuscitate Status
|
| August 13, 2021
CDRH
Patient Engagement Advisory Committee (Updated)
|
|
August 12, 2021
Class
I Recall: Baxter Healthcare Recalls Dose IQ Software Version 9.0.x,
Used with Spectrum IQ Infusion Pumps, for Software Defect That May
Improperly Configure Drug and Fluid Delivery
2018-2020
Strategic Priorities - Accomplishments
New Emergency Use Authorizations
- SelfCheck
COVID-19 TaqPath Multiplex PCR (Cleveland Clinic Robert J. Tomsich
Pathology and Laboratory Medicine Institute)
- Amazon
Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test (STS Lab Holdco
(a subsidiary of Amazon.com Services LLC))
- Amazon
Multi-Target SARS-CoV-2 Real-Time RT-PCR Test (STS Lab Holdco (a
subsidiary of Amazon.com Services LLC))
Reissued Emergency Use Authorizations
- Amazon
Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 (STS Lab Holdco
(a subsidiary of Amazon.com Services LLC))
- BinaxNOW
COVID-19 Antigen Self Test (Abbott Diagnostics Scarborough, Inc.)
- SGTi-flex
COVID-19 IgG (Sugentech, Inc.)
- ADVIA
Centaur SARS-CoV-2 IgG (sCOVG) (Siemens Healthcare Diagnostics Inc.)
- CovAb
SARS-CoV-2 Ab Test (Diabetomics, Inc.)
Baxter
Healthcare Recalls Dose IQ Software Version 9.0.x, Used with Spectrum
IQ Infusion Pumps, for Software Defect That May Improperly Configure
Drug and Fluid Delivery (Updated)
Discussion
Paper: Strengthening Cybersecurity Practices Associated with Servicing
of Medical Devices: Challenges and Opportunities (Updated)
|
|
August 11, 2021
Medical
Device Development Tools (MDDT) (Updated)
|
|
August 10, 2021
Stop
Using Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody
Tests: FDA Safety Communication (Updated)
Federal
Register: Meetings: Patient Engagement Advisory Committee
|
|
August 9, 2021
Revoked Emergency Use Authorizations
- Guardant-19
(Guardant Health, Inc.)
New Emergency Use Authorizations
- QIAreach
SARS-CoV-2 Antigen Test (QIAGEN GmbH)
Updated Emergency Use Authorizations
- CareStart
COVID-19 Antigen Home Test (Access Bio, Inc.)
- ACON
SARS-CoV-2 IgG/IgM Rapid Test (ACON Laboratories)
Reissued Emergency Use Authorizations
- CareStart
COVID-19 IgM/IgG (Access Bio, Inc.)
- Influenza
SARS-CoV-2 (Flu SC2) Multiplex Assay (Centers for Disease Control
and Prevention (CDC))
- SDNA-1000
Saliva Collection Device (Spectrum Solutions LLC)
- TaqPath
COVID-19, FluA, FluB Combo Kit (Thermo Fisher Scientific)
|
|
August 6, 2021
Medical
Device User Fee Rates for Fiscal Year 2022
FAQs
on Viral Transport Media During COVID-19 (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Class
I Recall: Boston Scientific Recalls INGENIO Family of Pacemakers
and CRT-Ps Due to Risk of Incorrect Transition to Safety Mode
|
|
August 5, 2021
Revoked Emergency Use Authorizations
- MatMaCorp
COVID-19 2SF Test
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - July 28, 2021
Accreditation
Scheme for Conformity Assessment (Updated)
- Accreditation
Bodies: How to Participate in the ASCA Pilot
- Testing
Laboratories: How to Participate in the ASCA Pilot
- Manufacturers:
How to Participate in the ASCA Pilot
Eight
Medical International Recalls Recirculator 8.0 Disposable Lavage
Kits due to Potential Exposure to High Levels of Aluminum
24
Hour Summary and Presentations for August 3, 2021 Circulatory System
Devices Panel of the Medical Devices Advisory Committee Meeting
Presentation
and Transcript added to Respirators and Other Personal Protective
Equipment (PPE) for Health Care Personnel Use During the COVID-19
Pandemic Webinar Series - July 13, 2021
|
|
August 4, 2021
Consumer
Information on: FoundationOne Liquid CDx – P190032/S001
Collaborative
Communities: Addressing Health Care Challenges Together (Updated)
Collaborative
Communities on Medical Devices - YouTube VideoExternal Link Disclaimer
FDA
News Release: FDA Participates in New ‘Collaborative Communities’
to Address Emerging Challenges in Medical Devices
Federal
Register: Guidance: Remanufacturing of Medical Devices
|
|
August 3, 2021
New Emergency Use Authorizations
- TaqPath
COVID-19 MS2 Combo Kit 2.0 (Life Technologies Corporation (a part
of Thermo Fisher Scientific Inc.)
- CareStart
COVID-19 Antigen Home Test (Access Bio, Inc.)
- LumiraDx
SARS-CoV-2 Ab Test (LumiraDx UK Ltd.)
Online
506J Notification Submission Methods: Frequently Asked Questions
(New)
Supplies
of Medical Devices for COVID-19: Frequently Asked Questions (Updated)
Contact
the FDA About a Medical Device Supply Chain Issue (Updated)
Class
I Recall: Philips Respironics Recalls V60 and V60 Plus Ventilators
Equipped with High Flow Therapy Software Versions 3.00 and 3.10
Due to Risk of Receiving Reduced Oxygen
MedSun
Newsletter - August 2021
3rd
Q FY 2021 MDUFA IV Performance Report
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Medical Device Recall Authority
|
|
August 2, 2021
New Emergency Use Authorizations
- INDICAID
COVID-19 Rapid Antigen Test (PHASE Scientific International, Ltd.)
- TaqPath
COVID-19 Fast PCR Combo Kit 2.0 (Life Technologies Corporation (a
part of Thermo Fisher Scientific Inc.))
Reissued Emergency Use Authorizations
- QIAstat-Dx
Respiratory SARS-CoV-2 Panel (QIAGEN GmbH)
- OraRisk
COVID-19 RT-PCR (Access Genetics, LLC)
- QuickVue
SARS Antigen Test (Quidel Corporation)
Revised Emergency Use Authorizations
- MidaSpot
COVID-19 Antibody Combo Detection Kit (Nirmidas Biotech, Inc.)
Updated Emergency Use Authorizations
- ePlex
Respiratory Pathogen Panel (GenMark Diagnostics, Inc.)
CDRH
Management Directory by Organization (Updated)
MQSA
National Statistics
|
| July 30, 2021
Materials
posted for August 3, 2021 Circulatory System Devices Panel of the
Medical Devices Advisory Committee Meeting
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests That Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
July 29, 2021
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - July 14, 2021
Quality
and Compliance (Medical Devices) (Updated)
UDI
Exceptions, Alternatives, and Time Extensions (Updated)
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- August 4, 2021
False
Positive Results with BD SARS-CoV-2 Reagents for the BD Max System
- Letter to Clinical Laboratory Staff and Health Care Providers
(Updated)
Philips
Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked
Questions
In
Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2
(Updated)
In
Vitro Diagnostics EUAs - IVDs for Management of COVID-19 Patients
(Updated)
In
Vitro Diagnostics EUAs - Serology and Other Adaptive Immune Response
Tests for SARS-CoV-2 (Updated)
In
Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2
(Updated)
|
|
July 28, 2021
Consumer
Information on: Centaur Anti-HBe2 – P200017
|
|
July 27, 2021
Consumer
Information on: The Arctic Front Advance and Arctic Front Advance
Pro and The Freezor MAX Cardiac Cryoablation Catheters – P100010/S110
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
List
of Cleared or Approved Companion Diagnostic Devices (In Vitro and
Imaging Tools) (Updated)
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Medical Device Reporting
|
|
July 26, 2021
Reissued Emergency Use Authorizations
-
Panther Fusion SARS-CoV-2 Assay (Hologic, Inc.)
-
Aptima SARS-CoV-2 assay (Aptima SARS-CoV-2 assay)
-
DetectX-Rv (PathogenDx, Inc.)
Updated Emergency Use Authorizations
-
Simplexa COVID-19 Direct assay (DiaSorin Molecular LLC)
Hyperbaric
Oxygen Therapy: Get the Facts
COVID-19
Update: FDA Authorizes Imported Becton Dickinson Sodium Citrate
Blood Specimen (Light Blue Top) Collection Tubes
|
| July 23, 2021
New Emergency Use Authorizations
-
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Reagent
Pack used in combination with the VITROS Immunodiagnostic Products
Anti-SARS-CoV-2 Total N Antibody Calibrators (Ortho-Clinical Diagnostics,
Inc.)
Reissued Emergency Use Authorizations
-
Simplexa COVID-19 Direct assay (DiaSorin Molecular LLC)
Revised Emergency Use Authorizations
-
CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) (Centers for
Disease Control and Prevention's (CDC))
-
Linea COVID-19 Assay Kit (Applied DNA Sciences, Inc.)
Revoked Emergency Use Authorizations
-
Gravity Diagnostics COVID-19 Assay (Gravity Diagnostics, LLC)
Federal
Register: Medical Devices: Class I Surgeon's and Patient Examination
Gloves
|
|
July 22, 2021
New Emergency Use Authorizations
-
BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site)
Stakeholder
Consultation Meetings - Medical Device User Fee Amendments 2023
(MDUFA V) (Updated)
Federal
Register: Authorization of Emergency Use of Certain Medical Devices
During COVID-19
Federal
Register: Medical Devices; Exemption from Premarket Notification:
Powered Patient Transport, All Other Powered Patient Transport
|
|
July 21, 2021
Partnerships
to Advance Innovation and Regulatory Science (PAIRS) (Updated)
Network
of Experts Program: Connecting the FDA with External Expertise (Updated)
Class
I Recall: Vero Biotech Recalls GENOSYL DS; Nitric Oxide Delivery
System Due to Software Error
FDA
Voices - FDA’s Budget: Medical Device Supply Chain and Shortages
Prevention Program
Neurological
Devices (Updated)
|
|
July 20, 2021
Catalog
of Regulatory Science Tools to Help Assess New Medical Devices (Updated)
24
Hour Summary for July 14, 2021 Gastroenterology and Urology Devices
Panel of the Medical Devices Advisory Committee Meeting
Transcripts
and Summaries for June 3-4, 2021 Neurological Devices Panel of the
Medical Devices Advisory Committee Meeting
|
|
July 19, 2021
Reissued Emergency Use Authorizations
-
PerkinsElmer New Coronavirus Nucleic Acid Detection Kit
-
ISPM Labs, LLC dbaCapstone Healthcare
Revised Emergency Use Authorizations
-
AMPIPROBE SARS-CoV-2 Test (Enzo Life Sciences, Inc.)
-
Ambry COVID-19 RT-PCR Test (Ambry Genetics Laboratory)
-
CareSTart COVID-19 Antigen Test (Access Bio, Inc.)
Updated Emergency Use Authorizations
-
RealStar SARS-CoV-2 RT-PCR Kits (Altona Diagnostics GmbH)
-
KimForest SARS-CoV-2 Detetion Kit v1 (KimForest Enterprise Co.,
Ltd.)
Updated Emergency Use Authorizations
-
Appendix A: Authorized Surgical Masks
-
Evaluation of Automatic Class III Designation (De Novo) Summaries
(DEN190043 added)
|
| July 16, 2021
Updated Emergency Use Authorizations
-
Appendix A: Authorized Surgical Masks
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
July, 15, 2021
New Emergency Use Authorizations
-
GenBody COVID-19 Ag (GenBody Inc.)
Reissued Emergency Use Authorizations
-
Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC (Color Health, Inc.)
Revised Emergency Use Authorizations
-
Color SARS-CoV-2 RT-LAMP Diagnostic Assay (Color Health, Inc.)
-
LIAISON SARS-CoV-2 Ag (DiaSorin, Inc.)
-
Elecsys Anti-SARS-CoV-2 (Roche Diagnostics)
-
Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette (Salofa
Oy)
Updated Emergency Use Authorizations
-
COVID-Flu Multiplex Assay (Exact Sciences Laboratories)
-
Clinical Enterprise SARS-CoV-2 RT-PCR Assay (Clinical Enterprise,
Inc.)
Historical
Information about Device Emergency Use Authorizations (Updated)
Removal
Lists of Tests That Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
Risk
of False Results with the Curative SARS-Cov-2 Test for COVID-19:
FDA Safety Communication (Updated)
In
Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2
(Updated)
In
Vitro Diagnostics EUAs - Serology and Other Adaptive Immune Response
Tests for SARS-CoV-2 (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Coronavirus
Disease 2019 (COVID-19) Emergency Use Authorizations for Medical
Devices - New Product Codes
Adverse
Event Reporting for Medical Devices Under Emergency Use Authorization
(EUA) or Discussed in COVID-19-Related Guidance Documents (Updated)
Potential
Concerns with NuVasive MAGEC System Implants - FDA Safety Communication
Presentations
posted for July 14, 2021 Gastroenterology and Urology Devices Panel
of the Medical Devices Advisory Committee Meeting
|
|
July 14, 2021
CDRH
Patient and Caregiver Connection (Updated)
|
|
July 13, 2021
Updated Emergency Use Authorizations
-
Appendix A: Authorized Surgical Masks
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200039
added)
Consumer
Information on: Restylane® Contour – P140029/S032
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
(Updated)
|
|
July 12, 2021
Updated Emergency Use Authorizations
-
NIOSH-Approved Air Purifying Respirators for Use in Health Care
Settings During Response to the COVID-19 Public Health Emergency
Materials
posted for July 14, 2021 Gastroenterology and Urology Devices Panel
of the Medical Devices Advisory Committee Meeting
June
2021 PMA Approval List
Virtual
Public Workshop - Orthopedic Cartilage Repair Products - November
12, 2021
Consumer
Update: Always Tired? You May Have Sleep Apnea
Consumer
Information on: TECNIS Synergy™ Intraocular Lens (IOL) (Model
ZFR00V), TECNIS Synergy™ Toric II IOL (Models ZFW150, ZFW225,
ZFW300, ZFW375), TECNIS Synergy™ IOL with TECNIS Simplicity™
Delivery System (Model DFR00V), TECNIS Synergy™ Toric II IOL
with TECNIS Simplicity™ Delivery System (Models DFW150, DFW225,
DFW300, DFW375) – P980040/S124
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Medical Device Labeling Regulations
|
| July 9, 2021
New Emergency Use Authorization
-
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative
Reagent Pack used in combination with the VITROS Immunodiagnostic
Products Anti- SARS-CoV-2 IgG Quantitative Calibrator (Ortho-Clinical
Diagnostics, Inc.)
-
TaqPath COVID-19 RNase P Combo Kit 2.0 (Thermo Fisher Scientific
Inc.)
-
ellume.lab COVID Antigen Test (Ellume Limited)
Reissued Emergency Use Authorizations
-
Quaeris SARS-CoV-2 Assay (Harvard University Clinical Laboratory
(HUCL))
Updated Emergency Use Authorizations
-
ViroKey SARS-CoV-2 RT-PCR Test v2.0 (Vela Operations Singapore Pte.
Ltd.)
-
SARS-CoV-2 DETECTR Reagent Kit (Mammoth Biosciences, Inc.)
-
cobas SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
July 8, 2021
Potential
Biocompatibility Concerns with NuVasive Specialized Orthopedics’
Precice Devices – Letter to Health Care Providers
Consumer
Information on: Guardant360 CDx – P200010/S001
|
|
July 7, 2021
Class
I Recall: Quidel Recalls Lyra SARS-CoV-2 Assay (M120) Due to Risk
of False Negative Results
Third
Party Review Organization Performance Report - FY21, Q3
Medical
Device User Fee Amendments 2023 (MDUFA V) (Updated)
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - June 30, 2021
|
|
July 6, 2021
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200050
added)
Unique
Device Identification System: Form and Content of the Unique Device
Identifier (UDI) - Guidance for Industry and Food and Drug Administration
Staff
UDI
Rule and Guidances, Training, Resources, and Dockets (Updated)
Contact
an FDA-Accredited Issuing Agency (Updated)
Federal
Register: Guidance: Unique Device Identification System; Form and
Content of the Unique Device Identifier
|
| July 2, 2021
New Emergency Use Authorizations
-
BioGX Xfree COVID-19 Direct RT-PCR (BioGX, Inc.)
-
COVID-Flu Multiplex Assay (Exact Sciences Laboratories)
-
Everlywell COVID-19 & Flu Test Home Collection Kit (Everlywell,
Inc.)
-
BioPlex 2200 SARS-CoV-2 IgG (Bio-Rad Laboratories)
Reissued Emergency Use Authorizations
-
Everlywell COVID-19 Test Home Collection Kit DTC (Everlywell, Inc.)
-
Assurance SARS-CoV-2 Panel DTC (Assurance Scientific Laboratories)
Revised Emergency Use Authorizations
-
SARS-CoV-2 NGS Assay (Twist Bioscience Corporation)
-
Alinity m Resp-4-Plex (Abbott Molecular Inc.)
Updated Emergency Use Authorizations
-
Rheonix COVID-19 MDx Assay (Rheonix, Inc.)
-
Assurance SARS-CoV-2 Panel (Assurance Scientific Laboratories)
-
Appendix A: Authorized Surgical Masks
Consumer
Information on: EPi-Sense® Guided Coagulation System –
P200002
Medtronic
Vascular Recalls Angiographic Guidewire Component Due to Being Non-sterile
MedSun
Newsletter - July 2021
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests That Should No Longer Be Used and/or Distributed
for COVID-19 (Updated)
|
|
July 1, 2021
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190023
added)
MQSA
National Statistics
Presentation
and Transcript added to Testing and Labeling Medical Devices for
Safety in the Magnetic Resonance (MR) Environment Webinar - June
24, 2021
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- July 14, 2021
Class
I Recall: Magellan Diagnostics Recalls LeadCare II, LeadCare Plus,
and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results
Webinar
Series - Respirators and Other Personal Protective Equipment (PPE)
for Health Care Personnel Use During the COVID-19 Pandemic - July
13, 2021
Federal
Register: Circulatory System Devices Panel of the Medical Devices
Advisory Committee
|
| June 30, 2021
Certain
Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled
Due to Potential Health Risks: FDA Safety Communication
Update:
FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated
Disposable Respirators - Letter to Health Care Personnel and Facilities
Revoked
EUAs for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Historical
Information about Device Emergency Use Authorizations (Updated)
Personal
Protective Equipment EUAs (Updated)
FAQs
on the EUAs for Non-NIOSH Approved Respirators During the COVID-19
Pandemic (Updated)
Importing
Medical Devices During the COVID-19 Pandemic (Updated)
Considerations
for Selecting Respirators for Your Health Care Facility (Updated)
Manufacturing
and Distributing Respirators for Health Care Personnel Use in the
United States Under an Existing Emergency Use Authorization (EUA)
During the COVID-19 Pandemic (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN180040,
DEN180067, DEN190016 and DEN190026 added)
Transcript
added to Virtual Public Workshop - Orthopedic Device Postmarket
Review - June 10, 2021
New Emergency Use Authorizations
-
Tidal Medical Technologies LLC, InSee
|
|
June 29, 2021
New Emergency Use Authorizations
-
CareStart EZ COVID-19 IgM/IgG (Access Bio, Inc.)
Reissued Emergency Use Authorizations
-
CareStart COVID-19 IgM/IgG (Access Bio, Inc.)
Revised Emergency Use Authorizations
-
ACON SARS-CoV-2 IgG/IgM Rapid Test (ACON Laboratories, Inc.)
-
COVID-19 Self-Collected Antibody Test System (Symbiotica, Inc.)
-
GeneFinder COVID-19 Plus RealAmp Kit (OSANG Healthcare)
-
cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on
the cobas Liat System (Roche Molecular Systems, Inc.)
Updated Emergency Use Authorizations
-
qSanger-COVID-19 Assay (BillionToOne, Inc.)
--
TRUPCR SARS-CoV-2 Kit (3B Blackbio Biotech India Ltd., a subsidiary
of Kilpest India Ltd.)
-
ViroKey SARS-CoV-2 RT-PCR Test (Vela Operations Singapore Pte Ltd)
-
PhoenixDx SARS-CoV-2 Multiplex (Trax Management Services Inc.)
-
Clinomics TrioDx RT-PCR COVID-19 Test (Clinomics USA Inc.)
-
Fulgent COVID-19 by RT-PCR Test (Fulgent Therapeutics)
-
cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
(cobas SARS-CoV-2) (Roche Molecular Systems)
Waiver
and Acknowledgment posted for July 14, 2021 Gastroenterology and
Urology Devices Panel of the Medical Devices Advisory Committee
Meeting
Federal
Register: Medical Devices-Exemption From Premarket Notification;
Powered Patient Transport, All Other Powered Patient Transport:
Correction
Federal
Register: MedWatch; The Food and Drug Administration Medical Products
Reporting Program
|
|
June 28, 2021
Updated
Emergency Use Authorizations
-
Viracor SARS-CoV-2 assay (Viracor Eurofins Clinical Diagnostics)
-
Biomeme SARS-CoV-2 Real-Time RT-PCR Test (Biomeme, Inc.)
- CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic
Assay (Version 3) (Clinical Research Sequencing Platform (CRSP),
LLC at the Broad Institute of MIT and Harvard)
-
Pooling and Serial Testing Amendment for Certain Molecular Diagnostic
Tests for SARS-CoV-2
|
| June 25, 2021
Flexible
Bronchoscopes and Updated Recommendations for Reprocessing: FDA
Safety Communication
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - June 16, 2021
Avid
Medical Recalls Medical Convenience Kits for Risk of Fungal Contamination
DeRoyal
Industries Recalls Surgical Procedure Packs for Mislabeled Lidocaine
Consumer
Information on: JUVÉDERM® VOLBELLA® XC – P110033
/ S053
Smiths
Medical Recalls Jelco Hypodermic Needle-Pro Fixed Needle Insulin
Syringes for Skewed Graduated Marks on Syringe Barrel That May Cause
Insulin Overdose or Underdose
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
June 24, 2021
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200017
added)
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- June 30, 2021
Transcript
added to Virtual Town Hall Series - Coronavirus (COVID-19) Test
Development and Validation - June 16, 2021
|
|
June 23, 2021
Device
Advice: Comprehensive Regulatory Assistance (Updated)
Contact
Us - Division of Industry and Consumer Education (DICE) (Updated)
CDRH
Learn (Updated)
REdI
Workshop (Updated)
Federal
Register: Remanufacturing of Medical Devices
|
|
June 22, 2021
New Emergency Use Authorizations
- WREN
Laboratories COVID-19 PCR Test DTC (WREN Laboratories LLC)
- WREN
Laboratories COVID-19 Saliva Test Collection Kit DTC (WREN Laboratories
LLC)
- cobas
SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas
SARS-CoV-2) (Roche Molecular Systems)
- ADVIA
Centaur SARS-CoV-2 IgG (sCOVG) (Siemens Healthcare Diagnostics Inc.)
Reissued Emergency Use Authorizations
- BioFire
COVID-19 Test (BioFire Defense, LLC)
- MobileDetect
Bio BCC19 (MD-Bio BCC19) (MobileDetect Bio Inc.)
- WREN
Laboratories COVID-19 PCR Test (WREN Laboratories LLC)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200031
added)
|
|
June 21, 2021
Clinical
Outcome Assessments (COAs) in Medical Device Decision Making
Observer
and Patient-Reported Outcomes for Ear Tube Delivery System
Clinical
Outcome Assessments Inform Indications for Use in Breakthrough Heart
Failure Symptoms Device
Clinical
Outcome Assessments Complement Evidence in Label Expansion for Transcatheter
Aortic Valve Replacement
Patient-Reported
Outcomes in Endpoints for Devices Treating Benign Prostate Hyperplasia
Symptoms
Clinical
Outcome Assessments Measure Aesthetic Procedure Success
Clinical
Outcome Assessments in Composite Endpoint for Upper Extremity Prosthetics
Clinician-Reported
Outcomes in Co-Primary Endpoint for Stroke Treatment Device
Clinical
Outcome Assessments in Composite Endpoints for Orthopedics
|
| June 17, 2021
Remanufacturing
of Medical Devices - Draft Guidance for Industry and Food and Drug
Administration Staff
Discussion
Paper: Strengthening Cybersecurity Practices Associated with Servicing
of Medical Devices: Challenges and Opportunities
Remanufacturing
and Servicing Medical Devices
Webinar
- Remanufacturing of Medical Devices Draft Guidance and Strengthening
Cybersecurity Practices Associated with Servicing of Medical Devices
Discussion Paper - July 27, 2021
Medical
Device Development Tools (MDDT) (Updated)
- Qualification
Summary: MDDT Summary of Evidence and Basis of Qualification Decision
for Patient-Reported Outcomes with LASIK (PROWL)
The
FDA's LASIK Program (Updated)
LASIK
Quality of Life Collaboration Project (Updated)
Temporomandibular
Joint (TMJ) Implants (Updated)
FDA's
Role in Approving TMJ Implants and Monitoring Their Safety
|
|
June 16, 2021
Reissued Emergency Use Authorizations
- Fulgent
COVID-19 by RT-PCR Test (Fulgent Therapeutics)
- Sofia
SARS Antigen FIA (Quidel Corporation)
Updated Emergency Use Authorizations
- Quaeris
SARS-CoV-2 Assay (Harvard University Clinical Laboratory (HUCL))
Class
I Recall: Infusion Pump Repair Recalls Alaris Infusion Pump Module
8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - June 9, 2021
FDA-Industry
MDUFA V Reauthorization Meeting, April 7, 2021
|
|
June 14, 2021
Reissued Emergency Use Authorizations
- CRSP
SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay
(Clinical Research Sequencing Platform (CRSP), LLC at the Broad
Institute of MIT and Harvard)
Updated Emergency Use Authorizations
- AerosolVE
Device (CInspire Rx, LLC)
- BioCode
SARS-CoV-2 Assay (Applied BioCode, Inc.)
- cobas
SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.)
- Alinity
m Resp-4-Plex (Abbott Molecular Inc.)
- EmpowerDX
COVID-19 Home Collection Kit DTC (Clinical Enterprise, Inc.)
-
Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 (STS Lab
Holdco (a subsidiary of Amazon.com Services LLC)
- CovAb
SARS-CoV-2 Ab Test (Diabetomics, Inc.)
Problems
Reported with Essure (Updated)
Federal
Register: Exemption from Premarket Notification: Powered Patient
Transport, All Other Powered Patient Transport
|
| June 11, 2021
Meeting
Notice: July 14, 2021 Gastroenterology and Urology Devices Panel
of the Medical Devices Advisory Committee
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests That Should No Longer Be Used and/or Distributed
for COVID-19 (Updated)
|
|
June 10, 2021
Stop
Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety
Communication
Class
I Recall: Innova Medical Group Recalls Unauthorized SARS-CoV-2 Antigen
Rapid Qualitative Test with Risk of False Test Results
Sodium
Citrate Blood Specimen Collection Tube Conservation Strategies –
Letter to Health Care and Laboratory Personnel
Medical
Device Shortages During the COVID-19 Public Health Emergency (Updated)
Federal
Register: Gastroenterology and Urology Devices Panel of the Medical
Devices Advisory Committee
|
|
June 9, 2021
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- June 16, 2021
Transcript
for May 4, 2021 Virtual Public Meeting - Patient-Generated Health
Data Throughout the Total Product Life Cycle of Medical Devices
|
|
June 8, 2021
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - June 2, 2021
Consumer
Information on: Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter
Heart Valve System – P140031/S125
24
Hour Summary for June 3-4, 2021 Neurological Devices Panel of the
Medical Devices Advisory Committee Meeting
|
|
June 7, 2021
New Emergency Use Authorizations
- Amazon
Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 (STS Lab Holdco
(a subsidiary of Amazon.com Services LLC))
- InteliSwab
COVID-19 Rapid Test Rx (OraSure Technologies, Inc.)
- InteliSwab
COVID-19 Rapid Test (OraSure Technologies, Inc.)
- InteliSwab
COVID-19 Rapid Test Pro (OraSure Technologies, Inc.)
- CovAb
SARS-CoV-2 Ab Test (Diabetomics, Inc)
Reissue Emergency Use Authorizations
- Amazon
Real-Time RT-PCR Test for Detecting SARS-CoV-2 (STS Lab Holdco (a
subsidiary of Amazon.com Services LLC))
- SalivaDirect
(Yale School of Public Health, Department of Epidemiology of Microbial
Diseases)
Updated Emergency Use Authorizations
- SynergyDx
SARS-CoV-2 RNA Test DTC (Synergy Diagnostic Laboratory, Inc., DBA
SynergyDx)
- SynergyDx
SARS-CoV-2 RNA Test (Synergy Diagnostic Laboratory, Inc., DBA SynergyDx)
- SalivaDirect
(Yale School of Public Health, Department of Epidemiology of Microbial
Diseases)
- Everlywell
COVID-19 Test Home Collection Kit (Everlywell, Inc.)
- Assurance
SARS-CoV-2 Panel (Assurance Scientific Laboratories)
- Gravity
Diagnostics SARS-CoV-2 RT-PCR Assay (Gravity Diagnostics, LLC)
Virtual
Public Workshop - Spinal Device Clinical Review - September 17,
2021
NIST
Request on Presidential Executive Order: Comments Submitted by the
FDA
|
|
June 4, 2021
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
June 3, 2021
Updated Emergency Use Authorization
- Appendix
A: Authorized Surgical Masks
Stop
New Implants of the Medtronic HVAD System – Letter to Health
Care Providers
MQSA
National Statistics
SARS-CoV-2
Viral Mutations: Impact on COVID-19 Tests - Accula SARS-CoV-2 Test
CDRH
Social Media: Twitter, Facebook, and LinkedIn (Updated)
|
|
June 2, 202
Sterility
Issues with Medical Devices Processed at Steril Milano Facilities
- Letter to Industry
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200069
added)
|
|
June 1, 2021
Reissued Emergency Use Authorizations
- Atellica
IM SARS-CoV-2 Total (COV2T) (Siemens Healthcare Diagnostics Inc.)
Updated Emergency Use Authorizations
- Pro-AmpRT
SARS-CoV-2 Test (Pro-Lab Diagnostics)
- TRUPCR
SARS-CoV-2 Kit (3B Blackbio Biotech India Ltd., a subsidiary of
Kilpest India Ltd.)
- COVID-19
RT-PCR Peptide Nucleic Acid (PNA) kit (BioTNS Co. Ltd.)
Meeting
Materials posted for June 3-4, 2021 Neurological Devices Panel of
the Medical Devices Advisory Committee
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190043
added)
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - May 26, 2021
Presentation
and Transcript added to Webinar - ASCA Pilot: Streamlining Conformity
Assessment in Device Submissions - May 20, 2021
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests That Should No Longer Be Used and/or Distributed
for COVID-19 (Updated)
|
| May 28, 2021
New Emergency Use Authorizations
- TaqPath
COVID-19 Pooling Kit (Thermo Fisher Scientific Inc.)
Reissued EmergencyUse Authorizations
- GetMyDNA
COVID-19 Test Home Collection Kit (GetMyDNA)
Updated Emergency Use Authorizations
- Lyra
Direct SARS-CoV-2 Assay (Quidel Corporation)
- Infinity
BiologiX TaqPath SARS-CoV-2 Assay (Infinity BiologiX LLC)
Class
I Recall: Lepu Medical Technology Recalls SARS-CoV-2 Antigen Rapid
Test Kit and Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal
Gold Immunochromatography) due to Risk of False Results
Stop
Using Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody
Tests: FDA Safety Communication
May
26, 2021 MDUFA IV Performance Report
Collaborative
Communities: Addressing Health Care Challenges Together (Updated)
Webinar
Series - Respirators and Other Personal Protective Equipment (PPE)
for Health Care Personnel Use During the COVID-19 Pandemic - June
8, 2021
|
|
May 27, 2021
Update:
FDA Recommends Transition from Use of Non-NIOSH-Approved and Decontaminated
Disposable Respirators - Letter to Health Care Personnel and Facilities
Federal
Register: Revocation of Authorization of Emergency Use of a Medical
Device During COVID-19; Availability
Federal
Register: Revocation of Authorization of Emergency Use of an In
Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19;
Availability
|
|
May 26, 2021
Procedures
for Handling Post-Approval Studies Imposed by Premarket Approval
Application Order - Draft Guidance for Industry and Food and Drug
Administration Staff
Postmarket
Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic
Act - Draft Guidance for Industry and Food and Drug Administration
Staff
Medical
Device Types to Help Determine Section 506J Notification Obligations
(Updated)
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- June 2, 2021
Collaborative
Communities: Addressing Health Care Challenges Together (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Federal
Register: Procedures for Handling Post-Approval Studies Imposed
by Premarket Approval Application Order; Draft Guidance
Federal
Register: Postmarket Surveillance under the Federal Food, Drug,
and Cosmetic Act; Draft Guidance
|
|
May 25, 2021
New Emergency Use Authorizations
- Quaeris
SARS-CoV-2 Assay (Harvard University Clinical Laboratory (HUCL))
- ADEXUSDx
COVID-19 Test (NOWDiagnostics, Inc.)
Re-issued Emergency Use Authorizations
- Bio-Speedy
Direct RT-qPCR SARS-CoV-2 (Bioeksen R&D Technologies Inc.)
- COVID-19
RT-PCR Peptide Nucleic Acid (PNA) kit (BioTNS Co. Ltd.)
- Aptima
SARS-CoV-2 assay (Hologic, Inc.)
Updated Emergency Use Authorizations
- Smart
Detect SARS-CoV-2 rRT-PCR Kit (InBios International, Inc.)
South
Korea's Response to COVID-19
Consumer
Information on: VENTANA MMR RxDx Panel – P200019
Webinar
on Implanted BCI Devices for Patients with Paralysis or Amputation
- Non-clinical Testing and Clinical Considerations Final Guidance
- July 29, 2021
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
May 24, 2021
Updated Emergency Use Authorizations
- Appendix
A: Authorized Surgical Masks
WebCast
Links for June 3-4, 2021: Neurological Devices Panel of the Medical
Devices Advisory Committee Meeting
Class
I Recall: Medical Action Industries, Inc. 306 Recalls Medical Convenience
Kits for Risk of Fungal (Aspergillus Penicillioides) Contamination
Medical
Device Shortages During the COVID-19 Public Health Emergency (Updated)
Medical
Device Types to Help Determine Section 506J Notification Obligations
(Updated)
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Shortages Data Collections
|
| May 21, 2021
New Emergency Use Authorizations
- Sienna-Clarity
COVID-19 Antigen Rapid Test Cassette (Salofa Oy)
- LIAISON
SARS-CoV-2 TrimericS IgG (DiaSorin, Inc.)
Reissued Emergency Use Authorizations
- LetsGetChecked
Coronavirus (COVID-19) Test (LetsGetChecked, Inc.)
- Kroger
Health COVID-19 Test Home Collection Kit (The Kroger Co.)
- Elecsys
Anti-SARS-CoV-2 (Roche Diagnostics)
Updated Emergency Use Authorizations
- New
York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic
Panel (Wadsworth Center, New York State Department of Public - Health)
- Genetron
SARS-CoV-2 RNA Test (Genetron Health (Beijing) Co., Ltd.)
- Biosearch
Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test (LGC,
Biosearch Technologies)
Mammography
Problems at Advanced Women Imaging in Guttenberg, NJ: FDA Safety
Communication
Class
I Recall: Boston Scientific Corporation Recalls VICI VENOUS STENT
System and VICI RDS VENOUS STENT System for Potential of Stent Migration
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- May 19, 2021 (Added Presentation and Transcript)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
May 20, 2021
Enforcement
Policy Regarding Use of National Health Related Item Code and National
Drug Code Numbers on Device Labels and Packages - Guidance for Industry
and Food and Drug Administration Staff
UDI
Exceptions, Alternatives and Time Extensions (Updated)
Unique
Device Identification System (UDI System) (Updated)
Safety
of Metals and Other Materials Used in Medical Devices (Updated)
CDRH’s
Research on Biological Responses to Metal-Containing Devices
Mammography
Problems at Capitol Radiology, LLC, doing business as Laurel Radiology
Services in Laurel, Maryland: FDA Safety Communication
Stop
Using Certain Syringes and Needles with Needle Safety Devices Manufactured
by HAIOU – Letter to Health Care Providers
Medical
Device Development Tools (MDDT) (Updated)
Federal
Register: Enforcement Policy Regarding Use of National Health Related
Item Code and National Drug Code Numbers on Device Labels and Package
|
|
May 19, 2021
New Emergency Use Authorizations
- Pinpoint
by Phosphorus COVID-19 Test Home Collection Kit DTC (Phosphorus
Diagnostics LLC)
- Phosphorous
COVID19 RT-qPCR Test DTC (Phosphorus Diagnostics LLC)
Reissued Emergency Use Authorizations
- Phosphorous
COVID-19 RT-qPCR Test (Phosphorus Diagnostics LLC)
- EmpowerDX
COVID-19 Home Collection Kit DTC (Clinical Enterprise, Inc.)
- binx
health At-Home Nasal Swab COVID-19 Sample Collection Kit (binx health,
Inc.)
- CRSP
SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay
(Version 3) (Clinical Research Sequencing Platform (CRSP), LLC at
the Broad Institute of MIT and Harvard)
- Viracor
SARS-CoV-2 assay DTC (Viracor Eurofins Clinical Diagnostics)
- SCoV-2
Detect IgG ELISA (InBios International, Inc.)
- ZEUS
ELISA SARS-CoV-2 IgG Test System (ZEUS Scientific, Inc.)
Updated Emergency Use Authorizations
- cobas
SARS-CoV-2 (Roche Molecular Systems, Inc. (RMS))
- GENETWORx
Covid-19 Nasal Swab Test (RCA Laboratory Services LLC dba GENETWORx)
Testing
and Labeling Medical Devices for Safety in the Magnetic Resonance
(MR) Environment - Guidance for Industry and Food and Drug Administration
Staff
Peripheral
Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions
- Guidance for Industry and Food and Drug Administration Staff
Feasibility
and Early Feasibility Clinical Studies for Certain Medical Devices
Intended to Therapeutically Improve Glycemic Control in Patients
with Type 2 Diabetes Mellitus - Draft Guidance for Industry and
Food and Drug Administration Staff
Implanted
Brain-Computer Interface (BCI) Devices for Patients with Paralysis
or Amputation - Non-clinical Testing and Clinical Considerations
- Guidance for Industry and Food and Drug Administration Staff
Antibody
Testing Is Not Currently Recommended to Assess Immunity After COVID-19
Vaccination: FDA Safety Communication
Webinar
- Testing and Labeling Medical Devices for Safety in the Magnetic
Resonance (MR) Environment - June 24, 2021
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- May 26, 2021
Voluntary
Medical Device Manufacturing and Product Quality Pilot Program (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Federal
Register: Feasibility and Early Feasibility Clinical Studies for
Certain Medical Devices Intended to Therapeutically Improve Glycemic
Control in Patients with Type 2 Diabetes Mellitus
Federal
Register: Implanted Brain-Computer Interface Devices for Patients
with Paralysis or Amputation - Non-Clinical Testing and Clinical
Considerations
Federal
Register: Peripheral Vascular Atherectomy Devices; Premarket Notification
Submissions
Federal
Register: Testing and Labeling Medical Devices for Safety in the
Magnetic Resonance Environment
|
|
May 18, 2021
Consumer
Information on: PyloPlus UBT System - P170022
510(k)
Third Party Performance Metrics and Accreditation Status (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
May 17, 2021
FDA
Activities Related to Essure
Problems
Reported with Essure
Essure
Frequently Requested Records
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - May 12, 2021
|
|
May 15, 2021
Presentation
and Transcript added to Webinar Series - Respirators and Other Personal
Protective Equipment (PPE) for Health Care Personnel Use During
the COVID-19 Pandemic - April 27, 2021
|
| May 14, 2021
Notice
of Meeting: June 3-4, 2021 Neurological Devices Panel of the Medical
Devices Advisory Committee
May
2021 MedSun Newsletter
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
May 13, 2021
Town
Hall Series - Coronavirus (COVID-19) Test Development and Validation
- May 19, 2021
Facility
Certification and Inspection Mammography Quality Standards Act (MQSA):
Inspection Fees (Updated)
Class
I Recall: Abbott (formally known as “St. Jude Medical”)
Recalls Assurity™ and Endurity™ Pacemakers for Potential
Moisture Ingress Causing Electrical Short and Reduced Battery Life
Magnets
in Cell Phones and Smart Watches May Affect Pacemakers and Other
Implanted Medical Devices
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Federal
Register: Meetings: Neurological Devices Panel of the Medical Devices
Advisory Committee
|
|
May 12, 2021
New Emergency Use Authorizations
- ZEUS
ELISA SARS-CoV-2 Total Antibody Test System (ZEUS Scientific, Inc.)
- QIAreach
Anti-SARS-CoV-2 Total Test (QIAGEN, GmbH)
- Lumensource
Surgical Mask Model # PKM-S201B (Lumensource, LLC)
Reissued Emergency Use Authorizations
- Linea
COVID-19 Assay Kit (Applied DNA Sciences, Inc.)
- Gravity
Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits (Gravity Diagnostics,
LLC)
- Pixel
by LabCorp COVID-19 Test Home Collection Kit (Laboratory Corporation
of America (LabCorp))
Updated Emergency Use Authorizations
- COVID-19
RT-PCR Test (Laboratory Corporation of America (Labcorp))
- COVID-19
Coronavirus Real Time PCR Kit (Jiangsu Bioperfectus Technologies
Co., Ltd.)
- GENETWORx
Covid-19 Nasal Swab Test (RCA Laboratory Services LLC dba GENETWORx)
- Celltrion
DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Class
I Recall: Medtronic, Inc. Recalls Instructions for Use and Patient
Manual for HeartWare HVAD System to Update Information about Carrying
Case, Driveline Cover, and Controller Power-Up Issues
|
|
May 11, 2021
Presentations
added to Virtual Public Meeting - Patient-Generated Health Data
Throughout the Total Product Life Cycle of Medical Devices - May
4, 2021
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - May 5, 2021
|
|
May 7, 2021
New Emergency Use Authorizations
- SCoV-2
Ag Detect Rapid Test (InBios International, Inc.)
Re-issued Emergency Use Authorizations
- Clarifi
COVID-19 Test Kit (Quadrant Biosciences Inc.)
Updated Emergency Use Authorizations
- BioFire
COVID-19 Test (BioFire Defense, LLC)
- SalivaDirect
At-Home Collection Kit (Yale School of Public Health, Department
of Epidemiology of Microbial Diseases)
- Aptima
SARS-CoV-2/Flu assay (Hologic, Inc.)
- Bio-Rad
Reliance SARS-CoV-2 RT-PCR Assay Kit (Bio-Rad Laboratories, Inc.)
- Elecsys
Anti-SARS-CoV-2 S (Roche Diagnostics, Inc.)
- Appendix
A: Authorized Surgical Masks
|
|
May 6, 2021
New Emergency Use Authorizations
- Negative
Pressure SteriDome (NPS)
Transcript
and Summary Minutes for April 6, 2021 Circulatory Devices Panel
of the Medical Devices Advisory Committee Meeting
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Class II Special Controls Guidance Document: Labeling
Natural Rubber Latex Condoms
|
|
May 5, 2021
Re-issued Emergency Use Authorizations
- Ambry
COVID-19 RT-PCR Test (Ambry Genetics Laboratory)
Updated Emergency Use Authorizations
- Ezplex
SARS-CoV-2 G Kit (SML GENETREE Co., Ltd.)
- MassARRAY
SARS-CoV-2 Panel (Agena Bioscience, Inc.)
- Elecsys
Anti-SARS-CoV-2 S (Roche Diagnostics, Inc.)
Webinar
- ASCA Pilot: Streamlining Conformity Assessment in Device Submissions
- May 20, 2021
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200019
added)
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - April 28, 2021
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- May 12, 2021
Consumer
Information on: Medtronic Harmony Transcatheter Pulmonary Valve
(TPV) System - P200046
Transcript
for March 23, 2021 General and Plastic Surgery Devices Panel of
the Medical Devices Advisory Committee Meeting
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
May 4, 2021
New Emergency Use Authorizations
- ISOCUBE
One and ISOCUBE SS (Prep Tech LLC)
Medical
Device Shortages During the COVID-19 Public Health Emergency (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Medical
Device Types to Help Determine Section 506J Notification Obligations
(Update)
|
|
May 3, 2021
Information
about Automated Endoscope Reprocessors (AERs) and FDA's Evaluation
(Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
| April 30, 2021
Updated Emergency Use Authorizations
- BD
SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson and Company
(BD))
- BD
SARS-CoV-2/Flu for BD MAX System (Becton, Dickinson and Company
(BD))
- Genetrack
SARS-CoV-2 Molecular Assay (Genetrack Biolabs, Inc.)
- DxTerity
SARS-CoV-2 RT PCR CE Test (DxTerity Diagnostics, Inc.)
- AQ-TOP
COVID-19 Rapid Detection Kit PLUS (SEASUN BIOMATERIALS, Inc.)
Revised Emergency Use Authorizations
- BioFire
Respiratory Panel 2.1-EZ (RP2.1-EZ) (BioFire Diagnostics, LLC)
- RapCov
Rapid COVID-19 Test (ADVAITE, Inc.)
- MosaiQ
COVID-19 Antibody Magazine (Quotient Suisse SA)
- SARS-CoV-2
IgG assay (Abbott Laboratories Inc.)
Re-issued Emergency Use Authorizations
- COVID-19
RT-PCR Test (Laboratory Corporation of America (LabCorp))
Revoked Emergency Use Authorizations
- Battelle
Decontamination System
Class
I Recall: Pacific Medical Group (DBA Avante Health Solutions) Recalls
Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or
Separated Bezel Repair Posts
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
April 29, 2021
Updated Emergency Use Authorizations
- Appendix
A: Authorized Surgical Masks
Consumer
Resources (Updated)
Virtual
Public Workshop - Orthopedic Device Postmarket Review - June 10,
2021
Sharps
Disposal Containers in Health Care Facilities
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
April 28, 2021
Updated Emergency Use Authorizations
- Appendix
B: Authorized Ventilator Accessories
EUA
Authorized Serology Test Performance (Updated)
Medical
Device User Fee Amendments (MDUFA) (Updated)
ASCA-Accredited
Testing Laboratories (Updated)
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- May 5, 2021
Federal
Register: Medical Device Reporting
Federal
Register: Modifications to the List of Recognized Standards, Recognition
List Numbers: 055
|
|
April 27, 2021
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - April 21, 2021
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
April 26, 2021
Re-issued Emergency Use Authorizations
- BD
SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson and Company
(BD))
- Illumina
COVIDSeq Test (Illumina, Inc.)
- Rapid
COVID-19 IgM/IgG Combo Test Kit (Megna Health, Inc.)
- SGTi-flex
COVID-19 IgG (Sugentech, Inc.)
Updated Emergency Use Authorizations
- NeuMoDx
Flu A-B/RSV/SARS-CoV-2 Vantage Assay (NeuMoDx Molecular, Inc.)
- EURORealTime
SARS-Cov-2 (Euroimmun US, Inc.)
- CareStart
COVID-19 IgM/IgG (Access Bio, Inc.)
510(k)
Program Pilots (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200046
added)
|
| April 23, 2021
Cordis
Recalls Precise PRO Rx US Carotid System Due to Risk of Separation
in Device During Use
FAQs
on Emergency Use Authorizations (EUAs) for Medical Devices During
the COVID-19 Pandemic (Updated)
Importing
Medical Devices During the COVID-19 Pandemic (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
April 22, 2021
New Emergency Use Authorizations
- Kaiser
Permanente High Throughput SARS-CoV-2 Assay (Southern California
Permanente Medical Group)
- DetectX-Rv
(PathogenDx, Inc.)
- QUANTA
Flash SARS-CoV-2 IgG (Inova Diagnostics, Inc.)
Re-issued Emergency Use Authorizations
- OPTI
SARS-CoV-2 RT PCR Test (OPTI Medical Systems, Inc.)
- Xpert
Omni SARS-CoV-2 (Cepheid)
Updated Emergency Use Authorizations
- Lyra
SARS-CoV-2 Assay (Quidel Corporation)
- BinaxNOW
COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.)
Federal
Register: Authorization of Emergency Use of Certain Medical Devices
During COVID-19
|
|
April 21, 2021
Updated Emergency Use Authorizations
- Appendix
A: Authorized Surgical Masks
Presentations
and Transcripts added to Virtual Town Hall Series - Coronavirus
(COVID-19) Test Development and Validation - December 2, 2020 and
April 14, 2021
New
CDRH Learn Modules: How to Use Consensus Standards in Premarket
Submissions and The ASCA Pilot: Streamlining Conformity Assessment
in Device Submissions
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- April 28, 2021
|
|
April 20, 2021
New Emergency Use Authorizations
- Pooling
and Serial Testing Amendment for Certain Molecular Diagnostic Tests
for SARS-CoV-2
Medtronic
Perfusion Systems Recalls Bio-Console 560 Extracorporeal Blood Pumping
Console for Possible Electrical Failure Causing the Pump to Stop
Webinar
Series - Respirators and Other Personal Protective Equipment (PPE)
for Health Care Personnel Use During the COVID-19 Pandemic - April
27, 2021
|
|
April 19, 2021
New Emergency Use Authorizations
- SynergyDx
SARS-CoV-2 RNA Test DTC (Synergy Diagnostic Laboratory, Inc., DBA
SynergyDx)
- SynergyDx
SARS-CoV-2 RNA Test (Synergy Diagnostic Laboratory, Inc., DBA SynergyDx)
- Celltrion
DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.)
- Healthcare
Pro Surgical Masks (BLUETRACK, Inc.)
- 3
Ply Surgical Mask (Manohar Filaments Private Limited)
Reissued Emergency Use Authorizations
- Amazon
Real-Time RT-PCR Test for Detecting SARS-CoV-2 (STS Lab Holdco (a
subsidiary of Amazon.com Services LLC))
Tenacore
Recalls Alaris Pump Bezel Assembly and Alaris Infusion Pumps repaired
with Bezel Assembly Due to Possible Cracked or Separated Bezel Repair
Posts
FDA-Industry
MDUFA V Reauthotization Meeting, March 17, 2021
Summary
Minutes for October 27, 2020 Circulatory System Devices Panel of
the Medical Devices Advisory Committee Meeting
Consumer
Information on: Simplify® Cervical Artificial Disc – P200022/S003
|
| April 16, 2021
New Emergency Use Authorizations
- Biosearch
Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test (LGC,
Biosearch Technologies)
Reissued Emergency Use Authorizations
- LumiraDx
SARS-CoV-2 Ag Test (LumiraDx UK Ltd.)
Updated Emergency Use Authorizations
- Allplex
2019-nCoV Assay (Seegene, Inc.)
- Color
COVID-19 Self-Swab Collection Kit with Saline (Color Health, Inc.)
- CareStart
COVID-19 Antigen test (Access Bio, Inc.)
Revised Emergency Use Authorizations
- Simoa
Semi-Quantitative SARS-CoV-2 IgG Antibody Test (Quanterix Corporation)
The
FDA issues final rule amending medical device classification regulations,
excluding non-device software functions
Class
I Recall: CareFusion 303, Inc. Recalls BD Alaris Pump Module Model
8100 Due to Risk of Stuck or Unresponsive Keys
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
April 15, 2021
New Emergency Use Authorizations
- SalivaDirect
At-Home Collection Kit (Yale School of Public Health, Department
of Epidemiology of Microbial Diseases)
- Color
COVID-19 Self-Swab Collection Kit with Saline (Color Health, Inc.)
Reissued Emergency Use Authorizations
- Color
SARS-CoV-2 RT-LAMP Diagnostic Assay (Color Health, Inc.)
- BD
Veritor System for Rapid Detection of SARS-CoV-2 (Becton, Dickinson
and Company (BD))
Updated Emergency Use Authorizations
- Gravity
Diagnostics SARS-CoV-2 RT-PCR Assay (Gravity Diagnostics, LLC)
- Fulgent
COVID-19 by RT-PCR Test (Fulgent Therapeutics)
- BinaxNOW
COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.)
- COVID-19
Self-Collected Antibody Test System (Symbiotica, Inc)
Federal
Register: Medical Devices: Class I Surgeon's and Patient Examination
Gloves
Federal
Register: Making Permanent Regulatory Flexibilities Provided During
the COVID-19 Public Health Emergency by Exempting Certain Medical
Devices from Premarket Notification Requirements; Withdrawal of
Proposed Exemptions
New
CDRH Learn Module - MDSAP: Production and Service Controls Process:
Part 3
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
Class
I Recall: Medtronic Recalls HeartWare HVAD Battery Cables, Data
Cables, Adapter Cables and Controller 2.0 Ports Due to Risk of Damage
to Controller Ports
|
|
April 14, 2021
New Emergency Use Authorizations
- Clinical
Enterprise SARS-CoV-2 RT-PCR Assay (Clinical Enterprise, Inc.)
- Clinical
Enterprise SARS-CoV-2 RT-PCR Assay DTC (Clinical Enterprise, Inc.)
- Omnia
SARS-CoV-2 Antigen Test (Qorvo Biotechnologies, LLC.)
Updated Emergency Use Authorizations
- cobas
SARS-CoV-2 (Roche Molecular Systems, Inc. (RMS))
- BD
SARS-CoV-2/Flu for BD MAX System (Becton, Dickinson and Company
(BD))
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- April 21, 2021
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
April 13, 2021
New Emergency Use Authorizations
- Amplitude
Solution with the TaqPath COVID-19 High-Throughput Combo Kit (Thermo
Fisher Scientific)
- PerkinElmer
SARS-CoV-2 RT-qPCR Reagent Kit (PerkinElmer Genomics)
- Airborne
Isolation Hood Device
Reissued Emergency Use Authorizations
- cobas
SARS-CoV-2 (Roche Molecular Systems, Inc. (RMS))
- Fulgent
COVID-19 by RT-PCR Test (Fulgent Therapeutics LLC)
- CareStart
COVID-19 Antigen test (Access Bio, Inc.)
- BinaxNOW
COVID-19 Ag Card Home Test (Abbott Diagnostics Scarborough, Inc.)
Updated Emergency Use Authorization
- MidaSpot
COVID-19 Antibody Combo Detection Kit (Nirmidas Biotech, Inc.)
New
CDRH Learn Module - MDSAP: Production and Service Controls Process:
Part 2
24
Hour Summary for April 6, 2021 Circulatory System Devices Panel
of the Medical Devices Advisory Committee Meeting
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200055
added)
|
|
April 12, 2021
New Emergency Use Authorizations
- Lucira
CHECK-IT COVID-19 Test Kit (Lucira Health, Inc.)
Re-issued Emergency Use Authorizations
- SalivaDirect
(Yale School of Public Health, Department of Epidemiology of Microbial
Diseases)
Updated Emergency Use Authorizations
- BD
SARS-CoV-2/Flu for BD MAX System (Becton, Dickinson and Company
(BD))
- Verily
COVID-19 RT-PCR Test (Verily Life Sciences)
ASCA-Accredited
Testing Laboratories
Class
I Recall: Medtronic Recalls Evera, Viva, Brava, Claria, Amplia,
Compia, and Visia Implantable Cardioverter Defibrillators (ICDs)
and Cardiac Resynchronization Therapy (CRT-Ds) Due to Risk of Shortened
Battery Life
Class
I Recall: Smisson-Cartledge Biomedical, LLC Recalls ThermaCor 1200
Disposable Sets for Risk of Patient Contact to Aluminum
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - April 7, 2021
Problems
Reported with Essure (Updated)
Consumer
Information on: ClearVisc Ophthalmic Viscosurgical Device –
P200025
Consumer
Information on: AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE,
FR3-ABE) – P190013
Consumer
Information on: Exablate Model 4000 System - Type 1.0 and 1.1 (Exablate
Neuro) P150038/S006
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
| April 9, 2021
FDA
Recommends Transition from Use of Decontaminated Disposable Respirators
- Letter to Health Care Personnel and Facilities
New
CDRH Learn Module - MDSAP: Production and Service Controls Process,
Part 1
Class
I Recall: Medtronic Recalls Valiant Navion Thoracic Stent Graft
System Due to Risk of Stent Fractures and Type III Endoleaks
Training
Curriculum for Third-Party Reviewers
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
MedSun
Newsletter - April 2021
|
|
April 8, 2021
New
CDRH Learn Module - MDSAP: Design and Development Process
FAQs
on Viral Transport Media During COVID-19 (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200038
added)
|
|
April 7, 2021
New Emergency Use Authorizations
- SARS-CoV-2
real time RT-PCR test (Authorized by HHS/OASH) (University of Louisville
Infectious Diseases Laboratory)
Updated Emergency Use Authorizations
- PhoenixDx
SARS-CoV-2 Multiplex (Trax Management Services Inc.)
- FTD
SARS-CoV-2 (Fast Track Diagnostics Luxembourg S.á.r.l. (a
Siemens Healthineers Company))
- SARS-CoV-2
Test (Biocerna)
- BinaxNOW
COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.)
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - March 31, 2021
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- April 14, 2021
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
April 6, 2021
New Emergency Use Authorizations
- COVID-19
Self-Collected Antibody Test System (Symbiotica, Inc.)
Updated Emergency Use Authorizations
- Appendix
A: Authorized Surgical Masks
Consumer
Information on: TheraSphere™ - P200029
New
CDRH Learn Modules - MDSAP: Measurement, Analysis and Improvement
Process and MDSAP: Medical Device Adverse Events and Advisory Notices
Reporting
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
April 5, 2021
Re-issued Emergency Use Authorizations
- covidSHIELD
(University of Illinois Office of the Vice President for Economic
Development and Innovation)
- Verily
COVID-19 RT-PCR Test (Verily Life Sciences)
- Alimetrix
SARS-CoV-2 RT-PCR Assay (Alimetrix, Inc.)
Updated Emergency Use Authorizations
- Dimension
EXL SARS-CoV-2 IgG (CV2G) (Siemens Healthcare Diagnostics Inc.)
- Dimension
Vista SARS-CoV-2 IgG (COV2G) (Siemens Healthcare Diagnostics Inc.)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
| April 2, 2021
New Emergency Use Authorizations
- LIAISON
SARS-CoV-2 Ag (DiaSorin, Inc.)
Re-issued Emergency Use Authorizations
- Sofia
SARS Antigen FIA (Quidel Corporation)
- VITROS
Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack (Ortho
Clinical Diagnostics, Inc.)
- Cue
COVID-19 Test (Cue Health Inc.)
- KPMAS
COVID-19 Test (For Kaiser Permanente Mid-Atlantic States)
- Gravity
Diagnostics SARS-CoV-2 RT-PCR Assay (Gravity Diagnostics, LLC)
- LumiraDx
SARS-CoV-2 RNA STAR Complete (LumiraDx UK Ltd.)
- P23
Labs TaqPath SARS-CoV-2 Assay (P23 Labs, LLC)
Updated Emergency Use Authorizations
- BinaxNOW
COVID-19 Antigen Self Test (Abbott Diagnostics Scarborough, Inc.)
- Atellica
IM SARS-CoV-2 IgG (sCOVG) (Siemens Healthcare Diagnostics Inc.)
- nHale
BiPAP device (Nanotronics Imaging, Inc.)
- Simplexa
COVID-19 Direct assay (DiaSorin Molecular LLC)
- cobas
SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.)
- Amazon
Real-Time RT-PCR Test for Detecting SARS-CoV-2 (STS Lab Holdco (a
subsidiary of Amazon.com Services LLC))
- CareStart
COVID-19 MDx RT-PCR (Access Bio, Inc.)
- BioFire
COVID-19 Test (BioFire Defense, LLC)
Revised Emergency Use Authorizations
- CareStart
COVID-19 IgM/IgG (Access Bio, Inc.)
- Real-Time
Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 (BGI Genomics Co.
Ltd)
- DxTerity
SARS-CoV-2 RT PCR CE Test (DxTerity Diagnostics, Inc.)
- PerkinElmer
New Coronavirus Nucleic Acid Detection Kit (PerkinElmer, Inc.)
Materials
for April 6, 2021 Circulatory System Devices Panel of the Medical
Devices Advisory Committee Meeting
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
April 1, 2021
New Emergency Use Authorizations
- QuickVue
At-Home OTC COVID-19 Test (Quidel Corporation)
- BinaxNOW
COVID-19 Antigen Self Test (Abbott Diagnostics Scarborough, Inc.)
- BinaxNOW
COVID-19 Ag Card 2 Home Test (Abbott Diagnostics Scarborough, Inc.)
- BinaxNOW
COVID-19 Ag 2 Card (Abbott Diagnostics Scarborough, Inc.)
- Individual
Biocontainment Unit (IBU)
Re-issued Emergency Use Authorizations
- BD
Veritor System for Rapid Detection of SARS-CoV-2 (Becton, Dickinson
and Company (BD))
New
CDRH Learn Modules - MDSAP: Management Process and MDSAP: Device
Marketing Authorization and Facility Registration
Infections
Associated with Reprocessed Urological Endoscopes - Letter to Health
Care Providers (Updated)
Information
for Health Care Facilities: Reprocessing of Reusable Medical Devices
MQSA
National Statistics
Accelerate
Sustainable Capability (ASC) Pilot Study Under MDIC (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
| March 31, 2021
Updated Emergency Use Authorizations
- Appendix
B: Authorized Ventilators
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - March 24, 2021
Acellular
Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction
Differ in Complication Rates: FDA Safety Communication
Consumer
Update: Traumatic Brain Injury: What to Know About Symptoms, Diagnosis,
and Treatment (Updated)
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- April 7, 2021
Federal
Register: Medical Devices; Technical Amendments
|
|
March 30, 2021
Updated Emergency Use Authorizations
- Appendix
A: Authorized Surgical Masks
Mammography
Problems at Tennessee Women’s Care P.C. in Nashville, TN: FDA
Safety Communication
FDA
News Release: FDA Allows for First Point-of-Care Chlamydia and Gonorrhea
Test to be Used in More Near-Patient Care Settings
Webinar
Series - Respirators and Other Personal Protective Equipment (PPE)
for Health Care Personnel Use During the COVID-19 Pandemic - April
27, 2021
SARS-CoV-2
Viral Mutations: Impact on COVID-19 Tests
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
March 29, 2021
New Emergency Use Authorizations
- AerosolVE
Device (CInspire Rx, LLC)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
| March 26, 2021
New Emergency Use Authorizations
- BD
Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B (Becton,
Dickinson and Company (BD))
- NeuMoDx
Flu A-B/RSV/SARS-CoV-2 Vantage Assay (NeuMoDx Molecular, Inc.)
- Amazon
Real-Time RT-PCR Test for Detecting SARS-CoV-2 (STS Lab Holdco (a
subsidiary of Amazon.com Services LLC))
Reissued Emergency Use Authorizations
- SCoV-2
Detect IgM ELISA (InBios International, Inc.)
Updated Emergency Use Authorizations
- Solana
SARS-CoV-2 Assay (Quidel Corporation)
- iC
SARS-CoV2 Test (Tempus Labs, Inc.)
- Access
SARS-CoV-2 IgG II (Beckman Coulter, Inc.)
- Aptima
SARS-CoV-2 assay (Hologic, Inc.)
|
|
March 25, 2021
eCopy
Validation Module for Medical Device Submissions
|
|
March 24, 2021
New Emergency Use Authorizations
- SARS-CoV-2
NGS Assay (Twist Bioscience Corporation)
- Atellica
IM SARS-CoV-2 IgG (sCOVG) (Siemens Healthcare Diagnostics Inc.)
Reissued Emergency Use Authorizations
- Umbrella
EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece
Respirators (FFRs)
Updated Emergency Use Authorizations
- Home
Specimen Collection Serology Template for Fingerstick Dried Blood
Spot
Medical
Device Regulatory Science Research Programs Conducted by OSEL (Updated)
FAQs
on the EUAs for Non-NIOSH Approved Respirators During the COVID-19
Pandemic (Updated)
New
CDRH Learn Modules: Introduction to the MDSAP Program and Overview
of the MDSAP Process
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
Class
I Recall: Medtronic Recalls Affinity Pixie™ Oxygenator and
Cardiotomy/Venous Reservoir with Balance™ Biosurface for Possible
High Levels of Endotoxins
|
|
March 23, 2021
New Emergency Use Authorizations
- Access
SARS-CoV-2 IgG II (Beckman Coulter, Inc.)
Reissued Emergency Use Authorizations
- Diazyme
DZ-Lite SARS-CoV-2 IgG CLIA Kit (Diazyme Laboratories, Inc.)
- iC
SARS-CoV2 Test (Tempus Labs, Inc.)
Updated Emergency Use Authorizations
- LumiraDx
SARS-CoV-2 RNA STAR Complete (LumiraDx UK Ltd.)
- Color
SARS-CoV-2 RT-LAMP Diagnostic Assay DTC (Color Health, Inc.)
Catalog
of Regulatory Science Tools to Help Assess New Medical Devices (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Federal
Register: Medical Devices: Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications
|
|
March 22, 2021
New Emergency Use Authorizations
- Color
COVID-19 Self-Swab Collection Kit DTC (Color Health, Inc.)
- Color
SARS-CoV-2 RT-LAMP Diagnostic Assay DTC (Color Health, Inc.)
- O2U
Ventilator: Model 100 (O2U, Inc.)
Reissued Emergency Use Authorizations
- Color
SARS-CoV-2 RT-LAMP Diagnostic Assay (Color Health, Inc.)
- Color
COVID-19 Self-Swab Collection Kit (Color Health, Inc.)
- LetsGetChecked
Coronavirus (COVID-19) Test (LetsGetChecked, Inc., LLC)
- VITROS
Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack (Ortho
Clinical Diagnostics, Inc.)
Updated Emergency Use Authorizations
- SalivaDirect
(Yale School of Public Health, Department of Epidemiology of Microbial
Diseases)
- CareStart
COVID-19 Antigen test (Access Bio, Inc.)
- VIDAS
SARS-CoV-2 IgM (bioMérieux SA)
- VIDAS
SARS-CoV-2 IgG (bioMérieux SA)
- AdviseDx
SARS-CoV-2 IgG II (Abbott Laboratories Inc.)
- Appendix
A: Authorized Surgical Masks and Surgical
Masks Removed from Appendix A
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
| March 19, 2021
New Emergency Use Authorizations
- Tiger
Tech Solutions, Inc., Tiger Tech COVID Plus Monitor
Updated Emergency Use Authorizations
- Appendix
A: Authorized Surgical Masks
- Appendix
B: Authorized Ventilator Accessories
Meeting
Materials for March 23, 2021 General and Plastic Surgery Devices
Panel of the Medical Devices Advisory Committee
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - March 10, 2021 and March 17, 2021
Virtual
Public Meeting - Patient-Generated Health Data Throughout the Total
Product Life Cycle of Medical Devices - May 4, 2021
eMDR
System Enhancements (Updated)
Coding
Resources for Medical Device Reports (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
March 18, 2021
Biocompatibility
Assessment Resource Center
Table
of Pharmacogenetic Associations (Updated)
MDUFA
IV Quarterly Performance Report - March 17, 2021
|
|
March 17, 2021
Revoked Emergency Use Authorizations
- BioFire
Respiratory Panel 2.1 (RP2.1)
Template
for Test Developers of Serology Tests that Detect or Correlate to
Neutralizing Antibodies (Word - 189 kb)
Serology
Template for Test Developers (Updated) (Word - 172kb)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200031
added)
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- March 24, 2021
Class
I Recall: ACIST Recalls Kodama Intravascular Ultrasound Catheter
Due to Risk of Broken O-Ring Pieces Flushing into Arteries During
Use
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
March 16, 2021
Screening
for COVID-19: Deciding Which Test to Use When Establishing Testing
Programs
Supplemental
Template for Developers of Molecular and Antigen Diagnostic COVID-19
Tests for Screening with Serial Testing (Word - 45kb)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
FDA
Voices: Leveraging Real World Evidence in Regulatory Submissions
of Medical Devices
Report:
Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory
Decisions
|
|
March 15, 2021
Updated Emergency Use Authorizations
- Appendix
B: Authorized Ventilator Accessories
FDA
Activities Related to Essure (Updated)
Problems
Reported with Essure (Updated)
CDRH
FOIA: How to Get Records from CDRH (Updated)
Risk
of Device Component Breaking in Patients with Stryker’s STAR
Ankle: FDA Safety Communication
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
| March 12, 2021
Re-Issued Emergency Use Authorizations
- WANTAI
SARS-CoV-2 Ab Rapid Test (Beijing Wantai Biological Pharmacy Enterprise
Co., Ltd.)
- VIDAS
SARS-CoV-2 IgM (bioMérieux SA)
- VIDAS
SARS-CoV-2 IgG (bioMérieux SA)
Revised Emergency Use Authorization
- Infinity
BiologiX TaqPath SARS-CoV-2 Assay (Infinity BiologiX LLC)
Class
I Recall: Combat Medical Systems, LLC, Recalls Valkyrie LTOWB Collection,
Valkyrie LTOWB Administration, Low Titer Type O FWB Transfusion
Set, Fresh Whole Blood Transfusion Set, Fresh Whole Blood Donor
Set for Possible Broken or Bent Needles
Potential
for False Results with Roche Molecular Systems, Inc. cobas SARS-CoV-2
& Influenza Test for use on cobas Liat System-Letter to Clinical
Laboratory Staff, Point-of-Care Facility Staff, and Health Care
Providers
|
|
March 11, 2021
Re-Issued Emergency Use Authorizations
- BD
SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson & Company)
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - March 3, 2021
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
March 10, 2021
New Emergency Use Authorizations
- GetMyDNA
COVID-19 Test Home Collection Kit (GetMyDNA)
Reissued Emergency Use Authorizations
- Gravity
Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits (Gravity Diagnostics,
LLC)
Updated Emergency Use Authorizations
- Solana
SARS-CoV-2 Assay (Quidel Corporation)
- T-Detect
COVID Test (Adaptive Biotechnologies Corporation)
- Trioplex
Real-time RT-PCR Assay (CDC)
MedSun
Newsletter, March 2021
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
March 9, 2021
Presentation
and Transcript added to Respirators and Other Personal Protective
Equipment (PPE) for Health Care Personnel Use During the COVID-19
Pandemic - February 23, 2021
|
|
March 8, 2021
New Emergency Use Authorizations
- Alinity
m Resp-4-Plex (Abbott Molecular Inc.)
- NxTAG
Respiratory Pathogen Panel + SARS-CoV-2 (Luminex Molecular Diagnostics,
Inc.)
- CRSP
SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay
(Version 3) (Clinical Research Sequencing Platform (CRSP), LLC at
the Broad Institute of MIT and Harvard)
Re-issued Emergency Use Authorizations
- binx
health At-Home Nasal Swab COVID-19 Sample Collection Kit (binx health,
Inc.)
Updated Emergency Use Authorizations
- Ambry
COVID-19 RT-PCR Test (Ambry Genetics Laboratory)
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
CDRH
Industry Basics Workshop: Consensus Standards and the Accreditation
Scheme for Conformity Assessment (ASCA) Pilot - April 13, 2021
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200006
added)
Consumer
Information on: Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBsCalCheck
– P190034
Update:
Medical Device Types to Help Determine Section 506J Notification
Obligations
|
|
March 5, 2021
New Emergency Use Authorizations
- Cue
COVID-19 Test for Home and Over The Counter (OTC) Use (Cue Health
Inc.)
- T-Detect
COVID Test (Adaptive Biotechnologies Corporation)
Updated Emergency Use Authorizations
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
|
|
March 4, 2021
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- March 10, 2021
Improper
Use of Thermal Imaging Devices: FDA Safety Communication
|
|
March 3, 2021
Meeting
Notice: April 6, 2021 - Circulatory System Devices Panel of the
Medical Devices Advisory Committee
Consumer
Information on: Restylane Defyne - P140029/S027
Consumer
Information on: Patient Specific Talus Spacer - H200001
Are
There "FDA Registered" or "FDA Certified" Medical
Devices? How Do I Know What Is FDA Approved?
February
2021 PMA Approval List
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
Federal
Register: Requests for Nominations: Device Good Manufacturing Practice
Advisory Committee
|
|
March 2, 2021
New Emergency Use Authorizations
- AdviseDx
SARS-CoV-2 IgG II (Abbott Laboratories Inc)
Updated Emergency Use Authorizations
- Phosphorus
COVID-19 RT-qPCR Test (Phosphorus Diagnostics LLC)
- QuickVue
At-Home COVID-19 Test (Quidel Corporation)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200022
added)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
Federal
Register: Meetings: Circulatory System Devices Panel of the Medical
Devices Advisory Committee
Federal
Register: Food and Drug Administration Modernization Act: Modifications
to the List of Recognized Standards, Recognition List Number: 054
|
|
March 1, 2021
New Emergency Use Authorizations
- QuickVue
At-Home COVID-19 Test (Quidel Corporation)
- covidSHIELD
(University of Illinois Office of the Vice President for Economic
Development and Innovation)
- Viracor
SARS-CoV-2 assay DTC (Viracor Eurofins Clinical Diagnostics)
Reissued Emergency Use Authorization
- Viracor
SARS-CoV-2 assay (Viracor Eurofins Clinical Diagnostics)
- EmpowerDX
At-Home COVID-19 PCR Test Kit (Clinical Enterprise, Inc.)
- Advanta
Dx SARS-CoV-2 RT-PCR Assay (Fluidigm Corporation)
Updated Emergency Use Authorizations
- AQ-TOP
COVID-19 Rapid Detection Kit (Seasun Biomaterials, Inc.)
- Aptima
SARS-CoV-2/Flu assay (Hologic, Inc.)
- TaqPath
COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
- Everlywell
COVID-19 Test Home Collection Kit DTC (Everlywell, Inc.)
- LetsGetChecked
Coronavirus (COVID-19) Test (LetsGetChecked, Inc.)
- SARS-CoV-2
RT-PCR Assay (Stanford Health Care Clinical Virology Laboratory)
- Appendix
B: Authorized Ventilators
- Trioplex
Real-time RT-PCR Assay (CDC) (Zika Virus EUA)
Medtronic
Recalls HVAD Pump Implant Kits Due to Delayed or Failed Restart
After the Pump is Stopped
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190022,
DEN200017 and DEN200028 added)
MQSA
National Statistics
Consumer
Information on: Elecsys Anti-HBe, PreciControl Anti-HBe – P190005
|
| February 26, 2021
Updated Emergency Use Authorizations
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
Consumer
Information on: Shockwave Intravascular Lithotripsy (IVL) System
with the Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
- P200039
Medical
Device Shortages During the COVID-19 Public Health Emergency (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
February 25, 2021
Updated Emergency Use Authorizations
- Appendix
B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator
Accessories
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- March 3, 2021
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
February 24, 2021
Updated Emergency Use Authorizations
- Appendix
B: Authorized Ventilator Accessories
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - February 17, 2021
|
|
February 23, 2021
Updated Emergency Use Authorizations
- DxTerity
SARS-CoV-2 RT PCR CE Test (DxTerity Diagnostics, Inc.)
- SalivaDirect
(Yale School of Public Health, Department of Epidemiology of Microbial
Diseases)
- BD
Veritor System for Rapid Detection of SARS-CoV-2 (Becton, Dickinson
and Company (BD))
- Appendix
B: Authorized Ventilators
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Prominent and Conspicuous Mark of Manufacturers on
Single-Use Devices
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Medical Devices; Humanitarian Use Devices
|
|
February 22, 2021
Reissued Emergency Use Authorizations
- Color
COVID-19 Self-Swab Collection Kit (Color Genomics, Inc.)
- LetsGetChecked
Coronavirus (COVID-19) Test (PrivaPath Diagnostics, Inc.)
Updated Emergency Use Authorizations
- Kroger
Health COVID-19 Test Home Collection Kit (The Kroger Co.)
- Everlywell
COVID-19 Test Home Collection Kit DTC (Everlywell, Inc.)
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
Policy
for Evaluating Impact of Viral Mutations on COVID-19 Tests - Guidance
for Test Developers and Food and Drug Administration Staff
Catalog
of Regulatory Science Tools to Help Assess New Medical Devices (Updated)
Class
I Recall: Hillrom Recalls Liko Multirall 200 Overhead Lift Due to
Failure to Properly Attach Q-Link Strap Lock (Also Known as Q-Link
1 Strap Lock) to S65 Hook
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals:Shortages Data Collections
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
13th
Annual FDA/AdvaMed Medical Devices Statistical Issues Conference
- May 10-12, 2021
|
| February 19, 2021
Updated Emergency Use Authorizations
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
Pulse
Oximeter Accuracy and Limitations: FDA Safety Communication
Class
I Recall: Boston Scientific Corporation Recalls EMBLEM S-ICD (Subcutaneous
Implantable Cardioverter Defibrillator) System Due to Risk of Short-Circuit
24
Hour Summary and Presentations for February 17, 2021 Circulatory
System Devices Panel of the Medical Devices Advisory Committee Meeting
|
|
February 18, 2021
Updated Emergency Use Authorizations
- Appendix
A: Authorized Respirators, Non-NIOSH Respirators Manufactured in
China
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- February 24, 2021
Listing
of CDRH Humanitarian Device Exemptions (Added H200001)
Dental
Amalgam Fillings Recommendations - Graphics
Medical
Device Shortages During the COVID-19 Public Health Emergency (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Federal
Register: Meetings: Medical Device User Fee Amendments of Fiscal
Years 2023 to 2027 Reauthorization
|
|
February 17, 2021
New Emergency Use Authorizations
- Gravity
Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits (Gravity Diagnostics,
LLC)
- Assurance
SARS-CoV-2 Panel DTC (Assurance Scientific Laboratories)
- Everlywell
COVID-19 Test Home Collection Kit DTC (Everlywell, Inc.)
Reissued Emergency Use Authorizations
- Kroger
Health COVID-19 Test Home Collection Kit (Kroger Co.)
Updated Emergency Use Authorizations
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
Webinar
Series - Respirators and Other Personal Protective Equipment (PPE)
for Health Care Personnel Use During the COVID-19 Pandemic - February
23, 2021
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - February 10, 2021
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Federal
Register: Charter Renewal: Technical Electronic Product Radiation
Safety Standards Committee
|
|
February 16, 2021
New Emergency Use Authorizations
- Visby
Medical COVID-19 Point of Care Test (Visby Medical, Inc.)
- Bio-Rad
Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit (Bio-Rad Laboratories,
Inc)
- BD
SARS-CoV-2/Flu for BD MAX System (Becton, Dickinson and Company
(BD))
- TaqPath
COVID-19, FluA, FluB Combo Kit (Thermo Fisher Scientific)
- Procleix
SARS-CoV-2 Assay (Grifols Diagnostic Solutions Inc.)
- IDS
SARS-CoV-2 IgG (Immunodiagnostic Systems Ltd.)
Reissued Emergency Use Authorization
- DxTerity
SARS-CoV-2 RT PCR CE Test (DxTerity Diagnostics, Inc.)
- LumiraDx
SARS-CoV-2 RNA STAR Complete (LumiraDx UK Ltd.)
- VITROS
Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack (Ortho-Clinical
Diagnostics, Inc.)
Updated Emergency Use Authorizations
- GENETWORx
Covid-19 Nasal Swab Test (RCA Laboratory Services LLC dba GENETWORx)
- CareStart
COVID-19 MDx RT-PCR (Access Bio, Inc.)
- U-TOP
COVID-19 Detection Kit (SEASUN BIOMATERIALS)
- Ellume
COVID-19 Home Test (Ellume Limited)
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
Revoked Emergency Use Authorizations
- Nova2200
for Decontaminating Compatible N95 Respirators
Meeting
Notice: March 23, 2021 General and Plastic Surgery Devices Panel
of the Medical Devices Advisory Committee
FDA
Voices: Reflections on a Record Year for Novel Device Innovation
Despite COVID-19 Challenges
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Consumer
Information on: Imagio® Breast Imaging System - P200003
|
| February 12, 2021
Updated Emergency Use Authorizations
- Appendix
B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator
Accessories
Meeting
Materials for February 17, 2021 Circulatory System Devices Panel
of the Medical Devices Advisory Committee Meeting
MDUFA
Reports
Federal
Register: Meetings: General and Plastic Surgery Devices Panel of
the Medical Devices Advisory Committee
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Medical Devices; Device Tracking
|
|
February 11, 2021
Updated Emergency Use Authorizations
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
|
|
February 10, 2021
Reissued Emergency Use Authorizations
- VITROS
Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack (Ortho
Clinical Diagnostics, Inc.)
Updated Emergency Use Authorizations
- Appendix
B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator
Accessories
Accreditation
Scheme for Conformity Assessment (ASCA) (Updated)
Consumer
Information on: DiamondTemp Ablation Catheters - P200028
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
February 9, 2021
Reissued Emergency Use Authorizations
- PerkinElmer
New Coronavirus Nucleic Acid Detection Kit (PerkinElmer, Inc.)
Updated Emergency Use Authorizations
- SalivaDirect
(Yale School of Public Health, Department of Epidemiology of Microbial
Diseases)
- QDX
SARS-CoV-2 Assay (QDx Pathology Services)
- MidaSpot
COVID-19 Antibody Combo Detection Kit (Nirmidas Biotech, Inc.)
- CareStart
COVID-19 Antigen test (Access Bio, Inc.)
- Appendix
B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator
Accessories
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
Using
Ventilator Splitters During the COVID-19 Pandemic - Letter to Health
Care Providers
Cochlear
Implants and MRI Safety
Listing
of CDRH Humanitarian Device Exemptions (Updated)
MedSun
Newsletter, February 2021
|
|
February 8, 2021
Updated Emergency Use Authorizations
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200018
added)
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - February 3, 2021
|
| February 5, 2021
New Emergency Use Authorizations
- BD
MAX COVID-19 ASSAY (Authorized by HHS/OASH) (Hospital of the University
of Pennsylvania)
- PMSF-INNO
SARS-CoV-2 RT-PCR Test (Authorized by HHS/OASH) (INNO Diagnostics
Reference Laboratory, Ponce Medical School)
- Clinomics
TrioDx RT-PCR COVID-19 Test (Clinomics USA Inc.)
- Status
COVID-19/Flu (Princeton BioMeditech Corp.)
Updated Emergency Use Authorizations
- IntelliPlex
SARS-CoV-2 Detection Kit (PlexBio Co., Ltd.)
- Accula
SARS-Cov-2 Test (Mesa Biotech Inc.)
- Lyra
SARS-CoV-2 Assay (Quidel Corporation)
- QuantiVirus
SARS-CoV-2 Test kit (DiaCarta, Inc)
- CareStart
COVID-19 MDx RT-PCR (Access Bio, Inc.)
- Cormeum
SARS-CoV-2 Assay (Cormeum Laboratory Services)
- Appendix
A: Authorized Surgical Masks and Surgical
Masks Removed from Appendix A
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
Presentation
and Transcript posted for Enforcement Policy for Bioburden Reduction
Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering
Facepiece Respirators during the COVID-19 Pandemic - January 26,
2021
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
February 4, 2021
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- February 10, 2021
Consumer
Information on: Revanesse® Lips+ - P160042/S010
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
Consumer
Information on: Gore® Excluder® Conformable AAA Endoprosthesis
- P200030
Consumer
Information on: Clareon Aspheric IOL, Clareon Toric Aspheric IOL,
Clareon Aspheric IOL, AutonoMe System, Clareon Toric IOL, AutonoMe
System - P190018
Consumer
Information on: Osseonachored Prostheses for Rehabiliation of Amputees
(OPRA)TM Implant System - P190009
|
|
February 3, 2021
Reissued Emergency Use Authorizations
- CareStart
COVID-19 Antigen test (Access Bio, Inc.)
Updated Emergency Use Authorizations
- Real-Time
Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 (BGI Genomics Co.
Ltd)
January
2021 PMA Approval List
Medical
Device Shortages During the COVID-19 Public Health Emergency (Updated)
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - January 27, 2021
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
February 2, 2021
Updated Emergency Use Authorizations
- Appendix
B: Authorized Ventilator Accessories
CDRH
Patient Science and Engagement Program
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
Class
I Recall: Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode
(Model 3501) Due to Risk of Fractures
|
|
February 1, 2021
Updated Emergency Use Authorizations
- VITROS
Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack (Ortho
- Clinical Diagnostics, Inc.)
- DSL
COVID-19 Assay (Diagnostic Solutions Laboratory, LLC)
- OPTI
SARS-CoV-2 RT PCR Test (OPTI Medical Systems, Inc.)
- SNL-NM
2019 nCoV Real-Time RT-PCR Diagnostic Assay (Sandia National Laboratories)
- CSI
SARS-CoV-2 RT PCR Test (CSI Laboratories)
- Appendix
A: Authorized Surgical Masks
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
Consumer
Information on: Restylane® Kysse - P140029/S021
MQSA
National Statistics
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
| January 29, 2021
Reissued Emergency Use Authorizations
- Real-Time
Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 (BGI Genomics Co.
Ltd)
Updated Emergency Use Authorizations
- Xpert
Xpress SARS-CoV-2/Flu/RSV (Cepheid)
- MassARRAY
SARS-CoV-2 Panel (Agena Bioscience, Inc.)
- BayCare
SARS-CoV-2 RT PCR Assay (BayCare Laboratories, LLC)
- Alpha
Genomix TaqPath SARS-CoV-2 Combo Assay (Alpha Genomix Laboratories)
- SARS-CoV-2
Assay (AIT Laboratories)
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
February
2021 Dates Announced for the Virtual Town Hall Series for Test Developers
on Coronavirus (COVID-19)
Penumbra’s
Recall of the JET 7 Reperfusion Catheter Due to Distal Tip Damage
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
January 28, 2021
Coagulation
Systems for Measurement of Viscoelastic Properties: Enforcement
Policy During the Coronavirus Disease 2019 (COVID-19) Public Health
Emergency (Revised) - Guidance for Industry and Food and Drug Administration
Staff
|
|
January 27, 2021
Reissued Emergency Use Authorizations
- FTD
SARS-CoV-2 (Fast Track Diagnostics Luxembourg S.á.r.l. (A
Siemens Healthineers Company))
Updated Emergency Use Authorizations
- Lyra
Direct SARS-CoV-2 Assay (Quidel Corporation)
- NeoPlex
COVID-19 Detection Kit (GeneMatrix, Inc.)
- LumiraDx
SARS-CoV-2 Ag Test (LumiraDx UK Ltd.)
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- February 3, 2021
Consumer
Information on: Vercise™ PC and Vercise Gevia™ Deep Brain
Stimulation (DBS) System - P150031/S028
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
January 26, 2021
New Emergency Use Authorizations
- Sovereign
America Surgical Mask, Model #: 2000SM1, Blue Color
Updated Emergency Use Authorizations
- MidaSpot
COVID-19 Antibody Combo Detection Kit - Nirmidas Biotech, Inc.
Webinar
Series - Respirators and Other Personal Protective Equipment (PPE)
for Health Care Personnel Use During the COVID-19 Pandemic (Updated)
Summary
Minutes for October 22, 2020 Patient Engagement Advisory Committee
Meeting
|
|
January 25, 2021
New Emergency Use Authorizations
- Procedure
Mask with Earloops, Model #: 559250M D (Honeywell International
Inc.)
- Ambry
COVID-19 RT-PCR Test (Ambry Genetics Laboratory)
Reissued Emergency Use Authorizations
- Express
Gene 2019-nCoV RT-PCR Diagnostic Panel (Express Gene LLC, DBA: Express
Gene Molecular Diagnostics Laboratory)
- NeuMoDx
SARS-CoV-2 Assay (NeuMoDx Molecular, Inc.)
Updated Emergency Use Authorizations
- Panther
Fusion SARS-CoV-2 Assay (Hologic, Inc.)
- Aptima
SARS-CoV-2 assay (Hologic, Inc.)
Accreditation
Scheme for Conformity Assessment (ASCA) Annual Report Through 2020
|
| January 22, 2021
New Emergency Use Authorizations
- F2001N
Respirator (Macopharma)
Reissued Emergency Use Authorizations
- Decontamination
Systems for Personal Protective Equipment EUAs (Updated)
Updated Emergency Use Authorizations
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
FAQs
for Filtering Facepiece Respirator (FFR) Decontamination Systems
PPE
Webinar Use of Dry Heat to Support Single-User Reuse of Certain
Respirators - January 26, 2021
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- January 27, 2021
Webinar
- Safer Technologies Program: Final Guidance - February 1, 2021
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- February 3, 10, 17, and 24, 2021
Third
Party Review Organization Performance Report for FY2021 Q1
Medical
Device Shortages During the COVID-19 Public Health Emergency (Updated)
|
|
January 21, 2021
New Emergency Use Authorizations
- KNH
Surgical Face Mask (KNH Enterprise Co., Ltd.)
Reissued Emergency Use Authorization
- Cleveland
Clinic SARS-CoV-2 Assay (Cleveland Clinic Robert J. Tomsich Pathology
and Laboratory Medicine Institute)
Updated Emergency Use Authorizations
- EliA
SARS-CoV-2-Sp1 IgG Test (Phadia AB)
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
Recognized
Consensus Standards Database (Updated)
Post-Approval
Studies Program (Updated)
522
Postmarket Surveillance Studies Program (Updated)
Mammography
Facility Adverse Event and Action Report - January 21, 2021: Ochiltree
County Hospital District
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
January 19, 2021
New Emergency Use Authorizations
- Bio-Rad
Reliance SARS-CoV-2 RT-PCR Assay Kit (Bio-Rad Laboratories, Inc.)
- UBI
SARS-CoV-2 ELISA (United Biomedical, Inc.)
- Yale
New Haven Health FFR Decontamination System
Updated Emergency Use Authorizations
- Ezplex
SARS-CoV-2 G Kit (SML GENETREE Co., Ltd.)
Consumer
Information on: Alinity m HCV - P190025
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - January 13, 2021
Webinar
Series - Respirators and Other Personal Protective Equipment (PPE)
for Health Care Personnel Use During the COVID-19 Pandemic - January
26, 2021
|
| January 15, 2021
Updated Emergency Use Authorizations
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
Summary
Minutes for November 6-7, 2019 General Hospital and Personal Use
Devices Panel of the Medical Devices Advisory Committee Meeting
Transcripts
for September 8-9, 2020 Orthopaedic and Rehabilitation Devices Panel
of the Medical Devices Advisory Committee Meeting
Summary
Minutes for September 8-9, 2020 Orthopaedic and Rehabilitation Devices
Panel of the Medical Devices Advisory Committee Meeting
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
January 14, 2021
New Emergency Use Authorizations
- Ezplex
SARS-CoV-2 G Kit (SML GENETREE Co., Ltd.)
Re-issued Emergency Use Authorizations
- BD
Veritor System for Rapid Detection of SARS-CoV-2 (Becton, Dickinson
and Company (BD))
- PerkinElmer
New Coronavirus Nucleic Acid Detection Kit (PerkinElmer, Inc.)
Updated Emergency Use Authorizations
- Sherlock
CRISPR SARS-CoV-2 Kit (Sherlock BioSciences, Inc.)
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
Coagulation
Systems for Measurement of Viscoelastic Properties: Enforcement
Policy During the Coronavirus Disease 2019 (COVID-19) Public Health
Emergency - Guidance for Industry and Food and Drug Administration
Staff
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
Summary
Minutes for Nov. 14, 2019 Immunology Devices Panel Meeting
Federal
Register: Making Permanent Regulatory Flexibilities Provided During
the COVID-19 Public Health Emergency by Exempting Certain Medical
Devices from Premarket Notification Requirements; Request for Information,
Research, Analysis, and Public Comment on Opportunities for Further
Science and Evidence-Based Reform of Section 510(k) Program
|
|
January 13, 2021
Updated Emergency Use Authorization
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Meeting
Notice: February 17, 2021 Circulatory System Devices Panel of the
Medical Devices Advisory Committee
Catalog
of Regulatory Science Tools to Help Assess New Medical Devices (Updated)
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- January 27, 2021
Mammography:
What You Need to Know (Updated)
Breast
Cancer Screening: Thermogram No Substitute for Mammogram (Updated)
What
to Know About Breast Implants (Updated)
December
2020 PMA Approval List
|
|
January 12, 2021
New Emergency Use Authorizations
- RapCov
Rapid COVID-19 Test (ADVAITE, Inc.)
- EliA
SARS-CoV-2-Sp1 IgG Test (Phadia AB)
- VITROS
Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack (Ortho
Clinical Diagnostics, Inc.)
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - January 6, 2021
Artificial
Intelligence/Machine Learning (AI/ML)-Based Software as a Medical
Device (SaMD) Action Plan
FDA
News Release: FDA Releases Artificial Intelligence/Machine Learning
Action Plan
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
Federal
Register: Meetings: Circulatory System Devices Panel of the Medical
Devices Advisory Committee
|
|
January 11, 2021
New Emergency Use Authorizations
- Dimension
EXL SARS-CoV-2 IgG (CV2G) (Siemens Healthcare Diagnostics Inc.)
- Dimension
Vista SARS-CoV-2 IgG (COV2G) (Siemens Healthcare Diagnostics Inc.)
Updated Emergency Use Authorizations
- Influenza
SARS-CoV-2 (Flu SC2) Multiplex Assay (Centers for Disease Control
and Prevention (CDC))
- Advanta
Dx SARS-CoV-2 RT-PCR Assay (Fluidigm Corporation)
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
Problems
Reported with Essure (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Update)
|
|
January 8, 2021
Re-issued Emergency Use Authorizations
- Accula
SARS-Cov-2 Test (Mesa Biotech Inc.)
- Xpert
Xpress SARS-CoV-2 test (Cepheid)
Updated Emergency Use Authorizations
- ExProbe
SARS-CoV-2 Testing Kit (TBG Biotechnology Corp.)
- OPTI
SARS-CoV-2 RT PCR Test (OPTI Medical Systems, Inc.)
- Genetrack
SARS-CoV-2 Molecular Assay (Genetrack Biolabs, Inc.)
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
EUA
Authorized Serology Test Performance (Updated)
Consumer
Information on: ActaStim-S Spine Fusion Stimulator - P190030
Genetic
Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular
Tests for Detection of SARS-CoV-2 - Letter to Clinical Laboratory
Staff and Health Care Providers
FDA
News Release: FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation
to Health Care Providers and Clinical Laboratory Staff
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
January 7, 2021
New Emergency Use Authorizations
- Sterile
Water for Humidifier (Vyaire Medical, Inc.)
Updated Emergency Use Authorizations
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
Accreditation
Scheme for Conformity Assessment (ASCA) (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Update)
Federal
Register: Requests for Nominations: National Mammography Quality
Assurance Advisory Committee
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January 6, 2021
New Emergency Use Authorizations
- Simoa
SARS-CoV-2 N Protein Antigen Test (Quanterix Corporation)
Re-issued Emergency Use Authorizations
- Sienna-Clarity
COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette (Salofa Oy)
- OPTI
SARS-CoV-2 RT PCR Test (OPTI Medical Systems, Inc.)
Updated Emergency Use Authorizations
- Primerdesign
Ltd COVID-19 genesig Real-Time PCR assay (Primerdesign Ltd.)
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- January 13, 2021
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January 5, 2021
Safer
Technologies Program for Medical Devices - Guidance for Industry
and Food and Drug Administration Staff
Requests
for Feedback and Meetings for Medical Device Submissions: The Q-Submission
Program - Guidance for Industry and Food and Drug Administration
Staff
Webinar
- Safer Technologies Program: Final Guidance
Safer
Technologies Program (SteP) for Medical Devices
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Federal
Register: Guidance: Safer Technologies Program for Medical Devices
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|
January 4, 2021
New Emergency Use Authorizations
- MidaSpot
COVID-19 Antibody Combo Detection Kit (Nirmidas Biotech, Inc.)
Re-issued Emergency Use Authorizations
- AMPIPROBE
SARS-CoV-2 Test System (Enzo Life Sciences, Inc.)
Updated Emergency Use Authorizations
- Quick
SARS-CoV-2rRT-PCR Kit (Zymo Research Corporation)
- Appendix
B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator
Accessories
MQSA
National Statistics
Mouse
Embryo Assay for Assisted Reproduction Technology Devices - Guidance
for Industry and Food and Drug Administration Staff
Risk
of False Results with the Curative SARS-Cov-2 Test for COVID-19:
FDA Safety Communication
Federal
Register: Guidance: Mouse Embryo Assay for Assisted Reproduction
Technology Devices
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
See the current
MedSun newsletter at the FDA website for Recalls and Safety Alerts,
Highlighted Reports, and Links to FDA/CDRH Databases and Other Information
Sources.
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