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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 30, 2022 - FDA
Roundup: December 30, 2022 |
| December 23, 2022 - FDA
Roundup: December 23, 2022 |
| December 22, 2022 - FDA
Approves New HIV Drug for Adults with Limited Treatment Options |
| December 20, 2022 - FDA
Roundup: December 20, 2022 |
| December 19, 2022 - Federal
Court Enters Consent Decree Against Oklahoma Drug Compounder |
| December 19, 2022 - FDA
Provides Update on External Evaluation to Strengthen Agency’s
Tobacco Program |
| December 16, 2022 - FDA
Roundup: December 16, 2022 |
| December 16, 2022 - FDA
Approves First Gene Therapy for the Treatment of High-Risk, Non-Muscle-Invasive
Bladder Cancer |
| December 16, 2022 - Coronavirus
(COVID-19) Update: FDA to Hold Advisory Committee Meeting to Discuss
Future Vaccination Regimens Addressing COVID-19 |
| December 13, 2022 - FDA
Roundup: December 13, 2022 |
| December 9, 2022 - FDA
Roundup: December 9, 2022 |
| December 8, 2022 - Coronavirus
(COVID-19) Update: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines
for Children Down to 6 Months of Age |
| December 6, 2022 - FDA
Roundup: December 6, 2022 |
| December 6, 2022 - FDA
Provides Update on External Evaluation to Strengthen Agency’s
Human Foods Program |
| November 30, 2022 - FDA
Approves First Fecal Microbiota Product |
| November 29, 2022 - FDA
Roundup: November 29, 2022 |
| November 22, 2022 - FDA
Approves First Gene Therapy to Treat Adults with Hemophilia B |
| November 22, 2022 - FDA
Roundup: November 22, 2022 |
| November 18, 2022 - FDA
Roundup: November 18, 2022 |
| November 17, 2022 - FDA
Approves First Drug That Can Delay Onset of Type 1 Diabetes |
| November 17, 2022 - FDA
Warns Seven Companies for Selling Dietary Supplements with Claims
to Treat Cardiovascular Disease |
| November 16, 2022 - FDA
Spurs Innovation for Human Food from Animal Cell Culture Technology |
| November 16, 2022 - FDA
Warns Firms for Selling Illegal E-cigarettes That Look Like Toys,
Food, and Cartoon Characters |
| November 15, 2022 - FDA
Roundup: November 15, 2022 |
| November 15, 2022 - FDA
Advances the New Era of Smarter Food Safety, Finalizing Foundational
Rule to Improve Traceability of Contaminated Foods |
| November 15, 2022 - FDA
Conditionally Approves First Drug to Manage Acute Onset of Pancreatitis
in Dogs |
| November 15, 2022 - FDA
Announces Preliminary Assessment that Certain Naloxone Products Have
the Potential to be Safe and Effective for Over-the-Counter Use |
| November 14, 2022 - FDA
Infant Formula Update: November 14, 2022 |
| November 8, 2022 - FDA
Roundup: November 8, 2022 |
| November 7, 2022 - FDA
Commissioner Tests Positive for COVID-19; Experiencing Mild Symptoms |
| November 4, 2022 - FDA
Roundup: November 4, 2022 |
| November 2, 2022 - FDA
Infant Formula Update: November 2, 2022 |
| November 1, 2022 - FDA
Roundup: November 1, 2022 |
| October 28, 2022 - FDA
Roundup: October 28, 2022 |
| October 26, 2022 - FDA
Denies Marketing of Logic’s Menthol E-Cigarette Products Following
Determination They Do Not Meet Public Health Standard |
| October 25, 2022 - FDA
Roundup: October 25, 2022 |
| October 21, 2022 - FDA
Roundup: October 21, 2022 |
| October 18, 2022 - FDA
Roundup: October 18, 2022 |
| October 18, 2022 - FDA,
DOJ Seek Permanent Injunctions Against Six E-cigarette Manufacturers |
| October 17, 2022 - FDA
Awards 19 Grants and Two Contracts Related to Rare Diseases, including
ALS |
| October 14, 2022 - FDA
Roundup: October 14, 2022 |
| October 12, 2022 - Coronavirus
(COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent
COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups |
| October 11, 2022 - FDA
Roundup: October 11, 2022 |
| October 7, 2022 - FDA
Roundup: October 7, 2022 |
| October 7, 2022 - FDA
Approves Vaccine for Use During Third Trimester of Pregnancy to Prevent
Whooping Cough in Infants Younger Than Two Months of Age |
| October 6, 2022 - New
Data Show More Than 2.5 Million U.S. Youth Currently Use E-Cigarettes |
| October 4, 2022 - FDA
Roundup: October 4, 2022 |
| September 30, 2022 - FDA
Roundup: September 30, 2022 |
| September 30, 2022 - FDA
Pathway Supports Long-Term Stability, Diversity of Safe and Nutritious
Infant Formula Supply in the U.S. |
| September 29, 2022 - FDA
Approves New Treatment Option for Patients with ALS |
| September 28, 2022 - FDA,
Veterans Health Administration Collaborate to Help Accelerate Medical
Device Innovation and Advancement of Care |
| September 28, 2022 - FDA
Proposes Updated Definition of ‘Healthy’ Claim on Food Packages
to Help Improve Diet, Reduce Chronic Disease |
| September 27, 2022 - FDA
Roundup: September 27, 2022 |
| September 27, 2022 - Coronavirus
(COVID-19) Update: FDA Updates COVID-19 Test Policy, Encourages Developers
to Seek Traditional Premarket Review for Most Test Types |
| September 23, 2022 - FDA
Roundup: September 23, 2022 |
| September 23, 2022 - New
FDA Draft Guidance Aims to Protect Children who Participate in Clinical
Trials |
| September 20, 2022 - FDA
Roundup: September 20, 2022 |
| September 20, 2022 - FDA
Committed to Strengthening U.S. Infant Formula Supply; Review Provides
Roadmap to Support Ongoing Efforts |
| September 20, 2022 - FDA
Concludes Internal Review of Agency Actions Related to the U.S. Infant
Formula Supply |
| September 16, 2022 - FDA
Roundup: September 16, 2022 |
| September 14, 2022 -
FDA and NIH Launch Public-Private Partnership for Rare Neurodegenerative
Diseases |
| September 13, 2022 - FDA
Roundup: September 13, 2022 |
| September 9, 2022 - FDA
Roundup: September 9, 2022 |
| September 8, 2022 - FDA
Issues Safety Alert for Squamous Cell Carcinoma and Various Lymphomas
in Scar Tissue around Breast Implants |
| September 7, 2022 - Monkeypox
Update: FDA Takes Significant Action to Help Expand Access to Testing |
| September 6, 2022 - Certain
Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to
Safety Issue with Magnets That May Affect Certain Medical Devices |
| September 6, 2022 - FDA
Roundup: September 6, 2022 |
| September 2, 2022 - FDA
Roundup: September 2, 2022 |
| August 31, 2022 - FDA
Approves First Treatment for Acid Sphingomyelinase Deficiency, a Rare
Genetic Disease |
| August 31, 2022 - Coronavirus
(COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent
COVID-19 Vaccines for Use as a Booster Dose |
| August 30, 2022 - FDA
Roundup: August 30, 2022 |
| August 26, 2022 - FDA
Roundup: August 26, 2022 |
| August 26, 2022 - FDA
Removes N95 Respirators from Medical Device Shortage List, Signaling
Sufficient Supply |
| August 25, 2022 - FDA
and Mexican Counterparts Report Progress in Food Safety at Second
Annual Partnership Meeting |
| August 23, 2022 - FDA
Roundup: August 23, 2022 |
| August 19, 2022 - FDA
Roundup: August 19, 2022 |
| August 18, 2022 - FDA
Warns Manufacturer for Marketing Illegal Flavored Nicotine Gummies |
| August 17, 2022 - FDA
Approves First Cell-Based Gene Therapy to Treat Adult and Pediatric
Patients with Beta-thalassemia Who Require Regular Blood Transfusions |
| August 16, 2022 - FDA
Roundup: August 16, 2022 |
| August 16, 2022 - FDA
Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing
Aids for Millions of Americans |
| August 12, 2022 - FDA
Roundup: August 12, 2022 |
| August 10, 2022 - FDA
Infant Formula Update: August 10, 2022 |
| August 9, 2022 - Monkeypox
Update: FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase
Vaccine Supply |
| August 9, 2022 - FDA
Roundup: August 9, 2022 |
| August 9, 2022 - FDA
Issues Warning Letters to Three Companies for Selling Unapproved New
Drugs for Mole and Skin Tag Removal |
| August 5, 2022 - FDA
Infant Formula Update: August 5, 2022 |
| August 5, 2022 - FDA
Approves First Targeted Therapy for HER2-Low Breast Cancer |
| August 5, 2022 - FDA
Roundup: August 5, 2022 |
| August 3, 2022 - FDA
Continues Efforts to Support Innovation in Medical Device Sterilization |
| August 2, 2022 - FDA
Roundup: August 2, 2022 |
| July 29, 2022 - FDA
Roundup: July 29, 2022 |
| July 29, 2022 - FDA
Provides Update on Agency Response to Monkeypox Outbreak |
| July 29, 2022 - FDA
Infant Formula Update: July 29, 2022 |
| July 27, 2022 - FDA
Seeks to Improve Patient Communication on LASIK Benefits and Risks
Through Issuance of Draft Guidance |
| July 26, 2022 - FDA
Roundup: July 26, 2022 |
| July 22, 2022 - FDA
Roundup: July 22, 2022 |
| July 22, 2022 - FDA
Details Optimized Approach for Regulatory Oversight Tools to Better
Protect Public Health |
| July 19, 2022 - FDA
Conducting Evaluation of Key Agency Activities to Strengthen Operations |
| July 19, 2022 - FDA
Roundup: July 19, 2022 |
|
July 15, 2022 - FDA
Roundup: July 15, 2022
|
| July 14, 2022 - FDA
Provides Educational Resources for Parents and Caregivers to Support
Confidence for Imported Infant Formula Products |
| July 13, 2022 - Coronavirus
(COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19
Vaccine, Adjuvanted |
| July 12, 2022 - FDA
Warns Four Companies for Selling Tainted Honey-based Products with
Hidden Active Drug Ingredients |
| July 8, 2022 - FDA
Infant Formula Update: July 8, 2022 |
| July 8, 2022 - FDA
Roundup: July 8, 2022 |
| July 6, 2022 - FDA
Developing New Framework for Continued, Expanded Access to Infant
Formula Options for U.S. Parents and Caregivers |
| July 6, 2022 - Coronavirus
(COVID-19) Update: FDA Authorizes Pharmacists to Prescribe Paxlovid
with Certain Limitations |
| July 6, 2022 - FDA
Infant Formula Update: July 6, 2022 |
| July 5, 2022 - FDA
Roundup: July 5, 2022 |
| July 1, 2022 - FDA
Roundup: July 1, 2022 |
| June 30, 2022 - Coronavirus
(COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component
for COVID-19 Vaccine Booster Doses |
| June 30, 2022 - FDA
Infant Formula Update: June 30, 2022 |
| June 28, 2022 - FDA
Roundup: June 28, 2022 |
| June 28, 2022 - FDA
Infant Formula Update: June 28, 2022 |
| June 27, 2022 - FDA
Introduces Innovative Proposal to Advance Consumer Access to Nonprescription
Drugs |
| June 27, 2022 - FDA
Infant Formula Update: June 27, 2022 |
| June 24, 2022 - FDA
Roundup: June 24, 2022 |
| June 23, 2022 - FDA
Releases Action Plan for Rare Neurodegenerative Diseases, Including
ALS |
| June 23, 2022 - FDA
Denies Authorization to Market JUUL Products |
| June 22, 2022 - FDA
Infant Formula Update: June 22, 2022 |
| June 22, 2022 - FDA
Provides Update on Efforts to Increase Supply and Availability of
Safe and Nutritious Infant Formula |
| June 21, 2022 - FDA
Announces Plans for Proposed Rule to Reduce Addictiveness of Cigarettes
and Other Combusted Tobacco Products |
| June 21, 2022 - FDA
Roundup: June 21, 2022 |
| June 17, 2022 - FDA
Infant Formula Update: June 17, 2022 |
| June 17, 2022 - FDA
Roundup: June 17, 2022 |
| June 17, 2022 - Coronavirus
(COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19
Vaccines for Children Down to 6 Months of Age |
| June 15, 2022 - FDA
Infant Formula Update: June 15, 2022 |
| June 14, 2022 - FDA
Roundup: June 14, 2022 |
| June 13, 2022 - FDA
Approves First Systemic Treatment for Alopecia Areata |
| June 10, 2022 - FDA
Roundup: June 10, 2022 |
| June 10, 2022 - FDA
Infant Formula Update: June 10, 2022 |
| June 9, 2022 - FDA
Infant Formula Update: June 9, 2022 |
| June 8, 2022 - FDA
Launches Campaign Aimed at Preventing E-Cigarette Use Among American
Indian/Alaska Native Youth |
| June 7, 2022 - FDA
Roundup: June 7, 2022 |
| June 3, 2022 - FDA
Roundup: June 3, 2022 |
| June 3, 2022 - FDA
Infant Formula Update: June 3, 2022 |
| June 2, 2022 - FDA
Launches New Dietary Supplement Education Initiative for Consumers,
Educators, and Healthcare Professionals |
| June 2, 2022 - FDA
Infant Formula Update: June 2, 2022 |
| May 31, 2022 - FDA
Roundup: May 31, 2022 |
| May 27, 2022 - FDA
Roundup: May 27, 2022 |
| May 27, 2022 - FDA
Efforts to Result in Millions of Additional Bottles of Infant Formula
to Further Increase U.S. Supply |
| May 26, 2022 - FDA
Flexibilities, Collaboration to Yield Millions of Bottles of Specialized
Medical Infant Formula in Coming Months to Increase U.S. Supply |
| May 24, 2022 - FDA
Flexibilities to Yield Millions of Cans of Additional Infant Formula
in Coming Months to Increase Supply Available to U.S. Consumers |
| May 24, 2022 - FDA
Roundup: May 24, 2022 |
| May 20, 2022 - FDA
Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune
Disorder |
| May 20, 2022 - FDA
Roundup: May 20, 2022 |
| May 19, 2022 - FDA
Urges Drug Manufacturers to Develop Risk Management Plans to Promote
a Stronger, Resilient Drug Supply Chain |
| May 19, 2022 - New
FDA Draft Guidance Aims to Increase Safety Information About Dietary
Supplement Marketplace |
| May 17, 2022 - FDA
Roundup: May 17, 2022 |
| May 17, 2022 - Coronavirus
(COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19
Vaccine Booster Dose to Children 5 through 11 Years |
| May 16, 2022 - FDA
Encourages Importation of Safe Infant Formula and Other Flexibilities
to Further Increase Availability |
| May 16, 2022 - FDA
Provides New Updates on Activities to Mitigate Infant Formula Supply
Challenges, Abbott Nutrition Agrees to Take Corrective Actions at
Facility to Produce Safe Infant Formula |
| May 16, 2022 - Coronavirus
(COVID-19) Update: FDA Authorizes First COVID-19 Test Available without
a Prescription That Also Detects Flu and RSV |
| May 13, 2022 - FDA
Roundup: May 13, 2022 |
| May 13, 2022 - FDA
Approves Novel, Dual-Targeted Treatment for Type 2 Diabetes |
| May 10, 2022 - FDA
Roundup: May 10, 2022 |
| May 10, 2022 - FDA
Takes Important Steps to Improve Supply of Infant and Specialty Formula
Products |
| May 6, 2022 - FDA
Roundup: May 6, 2022 |
| May 5, 2022 - Coronavirus
(COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain
Individuals |
| May 4, 2022 - FDA
Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s
Disease |
| May 4, 2022 - FDA
Issues Warning Letters to Companies Illegally Selling CBD and Delta-8
THC Products |
| May 3, 2022 - FDA
Roundup: May 3, 2022 |
| April 29, 2022 - FDA
Roundup: April 29, 2022 |
| April 29, 2022 - Coronavirus
(COVID-19) Update: FDA Announces Tentative Advisory Committee Meeting
Schedule Regarding COVID- 19 Vaccines |
| April 28, 2022 - FDA
Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars
to Prevent Youth Initiation, Significantly Reduce Tobacco-Related
Disease and Death |
| April 27, 2022 - FDA
Takes Steps to Limit Lead in Juice to Further Reduce Exposure to Toxic
Elements in Foods |
| April 26, 2022 - FDA
Roundup: April 26, 2022 |
| April 25, 2022 - Coronavirus
(COVID-19) Update: FDA Approves First COVID-19 Treatment for Young
Children |
| April 22, 2022 - FDA
Roundup: April 22, 2022 |
| April 20, 2022 - FDA
Considers New Approach to Improve Safe Disposal of Prescription Opioid
Analgesics, Decrease Unnecessary Exposure to Unused Medication |
| April 19, 2022 - FDA
Roundup: April 19, 2022 |
| April 19, 2022 - FDA
Warns of Risks Associated with Non-Invasive Prenatal Screening Tests |
| April 18, 2022 - FDA
Takes New Steps Regarding Evaluating Public Health Importance of Additional
Food Allergens |
| April 15, 2022 - FDA
Roundup: April 15, 2022 |
| April 14, 2022 - Coronavirus
(COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using
Breath Samples |
| April 13, 2022 - FDA
Issues Final Guidance on Animal Drug Compounding from Bulk Drug Substances |
| April 13, 2022 - FDA
Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical
Trials |
| April 12, 2022 - FDA
Roundup: April 12, 2022 |
| April 12, 2022 - FDA
and DEA Warn Online Pharmacies Illegally Selling Adderall to Consumers |
| April 8, 2022 - FDA
Roundup: April 8, 2022 |
| April 8, 2022 - Joint
Statement from CMS Administrator Chiquita Brooks-LaSure and FDA Commissioner
Robert M. Califf, M.D., on Ensuring Access to Safe and Effective Treatments |
| April 5, 2022 - FDA
Roundup: April 5, 2022 |
| April 1, 2022 - FDA
Roundup: April 1, 2022 |
| March 29, 2022 - FDA
Roundup: March 29, 2022 |
| March 29, 2022 - Coronavirus
(COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19
Vaccines for Older and Immunocompromised Individuals |
| March 28, 2022 - FDA
Seeks $8.4 Billion to Further Investments in Critical Public Health
Modernization, Core Food and Medical Product Safety Programs |
| March 28, 2022 - Federal
judge enters consent decree against New Jersey raw animal food manufacturer |
| March 25, 2022 - FDA
Roundup: March 25, 2022 |
| March 24, 2022 - FDA
Issues Decisions on Additional E-Cigarette Products |
| March 22, 2022 - FDA
Roundup: March 22, 2022 |
| March 22, 2022 - FDA
Statement on Medical Device User Fee Amendments (MDUFA) |
| March 21, 2022 - Coronavirus
(COVID-19) Update: FDA to Hold Advisory Committee Meeting on COVID-19
Vaccines to Discuss Future Boosters |
| March 18, 2022 - FDA
Roundup: March 18, 2022 |
| March 17, 2022 - FDA,
Reagan-Udall Foundation to Hold Important Public Workshop to Discuss
Naloxone Access |
| March 15, 2022 - FDA
Roundup: March 15, 2022 |
| March 15, 2022 - FDA
Approves First Generic of Symbicort to Treat Asthma and COPD |
| March 11, 2022 - FDA
Roundup: March 11, 2022 |
| March 10, 2022 - FDA
Orders Philips Respironics to Notify Patients Regarding the Recall
of Certain Breathing Assistance Machines |
| March 8, 2022 - FDA
Roundup: March 8, 2022 |
| March 7, 2022 - FDA
Makes Low-Risk Determination for Marketing of Products from Genome-Edited
Beef Cattle After Safety Review |
| March 4, 2022 - FDA
Roundup: March 4, 2022 |
| March 3, 2022 - FDA
Urges Companies to be ’Recall Ready’ to Protect Public Health
as Part of Final Guidance for Voluntary Recalls |
| March 1, 2022 - FDA
Roundup: March 1, 2022 |
| March 1, 2022 - FDA
Clinical Trial Guidances Share Biden Administration’s Goals for
Advancing Development of Cancer Treatments |
| February 25, 2022 - FDA
Roundup: February 25, 2022 |
| February 24, 2022 - FDA
Approves Treatment for Wider Range of Patients with Heart Failure |
| February 23, 2022 - FDA
Permits Marketing of First Condom Specifically Indicated for Anal
Intercourse |
| February 22, 2022 - FDA
Roundup: February 22, 2022 |
| February 18, 2022 - FDA
Alerts the Public to Potentially Contaminated Products from Family
Dollar Stores in Six States |
| February 18, 2022 - FDA
Roundup: February 18, 2022 |
| February 17, 2022 - FDA
Warns Consumers Not to Use Certain Powdered Infant Formula Produced
in Abbott Nutrition’s Facility in Sturgis, Michigan |
| February 15, 2022 - FDA
Roundup: February 15, 2022 |
| February 11, 2022 - FDA
Roundup: February 11, 2022 |
| February 11, 2022 - Coronavirus
(COVID-19) Update: FDA Authorizes New Monoclonal Antibody for Treatment
of COVID-19 that Retains Activity Against Omicron Variant |
| February 11, 2022 - Coronavirus
(COVID-19) Update: FDA Postpones Advisory Committee Meeting to Discuss
Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for
Children 6 Months Through 4 Years of Age |
| February 9, 2022 - FDA
Takes Steps Aimed at Fostering Development of Non-Addictive Alternatives
to Opioids for Acute Pain Management |
| February 8, 2022 - FDA
Roundup: February 8, 2022 |
| February 4, 2022 - FDA
Roundup: February 4, 2022 |
| February 4, 2022 - FDA
Sodium Reduction Efforts Underscored in USDA’s Transitional Nutrition
Standards for School Meals |
| February 2, 2022 - FDA
Approves First Generic of Restasis |
| February 1, 2022 - Coronavirus
(COVID-19) Update: FDA Advisory Committee Meeting to Discuss Request
for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children
6 Months Through 4 Years of Age |
| February 1, 2022 - FDA
Roundup: February 1, 2022 |
| January 31, 2022 - Coronavirus
(COVID-19) Update: FDA Takes Key Action by Approving Second COVID-19
Vaccine |
| January 28, 2022 - FDA
Roundup: January 28, 2022 |
| January 25, 2022 - FDA
Roundup: January 25, 2022 |
| January 24, 2022 - Coronavirus
(COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies
to Treat COVID-19 Due to the Omicron Variant |
| January 21, 2022 - FDA
Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate
COVID-19 |
| January 21, 2022 - FDA
Roundup: January 21, 2022 |
| January 18, 2022 - FDA
Roundup: January 18, 2022 |
| January 18, 2022 - FDA
Releases CDRH Health of Women Strategic Plan to Better Inform Medical
Device Research and Regulation for All Women |
| January 14, 2022 - FDA
Roundup: January 14, 2022 |
| January 13, 2022 - FDA
Releases Federal Interagency Working Group Scientific Opinions on
Testing Methods for Asbestos in Talc-Containing Cosmetic Products |
| January 13, 2022 - FDA
Approves Novel Treatment to Control Pain in Cats with Osteoarthritis,
First Monoclonal Antibody Drug for Use in Any Animal Species |
| January 11, 2022 - FDA
Roundup: January 11, 2022 |
| January 7, 2022 - FDA
Roundup: January 7, 2022 |
| January 7, 2022 - Coronavirus
(COVID-19) Update: FDA Shortens Interval for Booster Dose of Moderna
COVID-19 Vaccine to Five Months |
| January 4, 2022 -
FDA Roundup: January 4, 2022 |
| January 3, 2022 -
Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand
Use of Pfizer-BioNTech COVID-19 Vaccine |
For the most up to date FDA headlines, see the FDA
Medical Device News page.
| December 29, 2022
Updated Emergency Use Authorizations
- BinaxNOW
COVID-19 Antigen Self Test (Abbott Diagnostics Scarborough, Inc.)
- iHealth
COVID-19 Antigen Rapid Test Pro (iHealth Labs, Inc.)
Revised Emergency Use Authorizations
- INDICAID
COVID-19 Rapid Antigen Test (PHASE Scientific International, Ltd.)
Total
Product Life Cycle Advisory Program (TAP) (Updated)
Federal
Register: Neurological Devices; Classification of the Pediatric
Autism Spectrum Disorder Diagnosis Aid
Federal
Register: Emergency Use Authorization: In Vitro Diagnostic
Device in Response to an Outbreak of Mpox
|
|
December 28, 2022
SARS-CoV-2
Viral Mutations: Impact on COVID-19 Tests (Updated)
Federal
Register: Cardiovascular Devices; Classification of the Extracorporeal
System for Carbon Dioxide Removal
Federal
Register: Orthopedic Devices; Classification of the Resorbable
Implant for Anterior Cruciate Ligament Repair
|
|
December 27, 2022
New Emergency Use Authorizations
- VIASURE
Monkeypox virus Real Time PCR Reagents for BD MAX System (Becton,
Dickinson & Company (BD))
- Visby
Medical Respiratory Health Test (Visby Medical, Inc.)
Updated Emergency Use Authorizations
- Rapid
SARS-CoV-2 Antigen Test Card (Xiamen Boson Biotech Co., Ltd.)
- BinaxNOW
COVID-19 Antigen Self Test (Abbott Diagnostics Scarborough, Inc.)
- INDICAID
COVID-19 Rapid Antigen At-Home Test (PHASE Scientific International,
Ltd.)
- SCoV-2
Ag Detect Rapid Test (InBios International, Inc.)
- SCoV-2
Ag Detect Rapid Self-Test (InBios International, Inc.)
MedSun
Newsletter - January 2023
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN220017 added)
Federal
Register: Cardiovascular Devices; Classification of the Interventional
Cardiovascular Implant Simulation Software Device
|
| December 23, 2022
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
December 22, 2022
New Emergency Use Authorizations
- ASSURE-100
Rapid COVID-19 Home Test (Oceanit Foundry LLC)
- Advin
COVID-19 Antigen Test @Home (Advin Biotech Inc.)
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
Consumer
Information on: Magtrace and Sentimag Magnetic Localization System
- P160053/S002
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190029,
DEN190032, DEN190047, and DEN200064 added)
Certain
Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled
Due to Potential for Silicone Foam Adhesion Failure and Residual
PE-PUR Foam Debris: FDA Safety Communication
|
|
December 21, 2022
New Emergency Use Authorizations
- ImmuView
COVID-19 Antigen Home Test (CTK Biotech, Inc.)
- Hi-Sense
COVID-19 Molecular Testing Kit 1.0 (OnsiteGene, Inc.)
Updated Emergency Use Authorizations
- 1copy
COVID-19 qPCR Multi Kit (1drop Inc.)
- CorDx
COVID-19 Ag Test (CorDX, Inc.)
Revised Emergency Use Authorizations
- MaximBio
ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.)
Reissued Emergency Use Authorizations
- Nano-Check
COVID-19 Antigen Test (Nano-Ditech Corp.)
CDRH
Management Directory by Organization (Updated)
|
|
December 20, 2022
Class
I Recall: Arrow International, LLC, subsidiary of Teleflex,
Inc Recalls Arrow AutoCAT 2, AC3 Intra-Aortic Balloon Pumps for
Unexpectedly Short Battery Run Times
Transcript
and Summary Minutes: November 10, 2022 Ophthalmic Devices Panel
of the Medical Devices Advisory Committee Meeting
Transcript
and Summary Minutes: November 1, 2022 Anesthesiology and Respiratory
Therapy Devices Panel of the Medical Devices Advisory Committee
Meeting
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN220012
added)
Exemptions,
Variances, and Alternative Forms of Adverse Event Reporting for
Medical Devices
|
|
December 19, 2022
Revoked Emergency Use Authorizations
- DETECTR
BOOST SARS-CoV-2 Reagent Kit (Mammoth Biosciences, Inc.)
- SARS-CoV-2
DETECTR Reagent Kit (Mammoth Biosciences, Inc.)
- COVID-19
ELISA pan-Ig Antibody Test (University of Arizona Genetics Core
for Clinical Services)
Personal
Protective Equipment EUAs: Surgical Masks Removed from Appendix
A (Updated)
Virtual
Town Hall Series - Test Development and Validation During Public
Health Emergencies Monkeypox (mpox) and COVID-19 - January 11, 2023
|
| December 16, 2022
2023
OSEL Summer Research Program
Ventilators
and Ventilator Accessories EUAs (Updated)
Class
I Recall: Teleflex and Arrow International, LLC Recall Arrow MAC
Two-Lumen Central Venous Access and Pressure Injectable Arrowg+ard
Blue Plus Three-Lumen Central Venous Catheter (CVC) Kits
Personal
Protective Equipment EUAs: Surgical Masks Removed from Appendix
A (Updated)
|
|
December 15, 2022
New Emergency Use Authorizations
- TaqPath
Monkeypox/Orthopox Virus DNA Kit (Life Technologies Corporation
(a part of Thermo Fisher Scientific Inc.))
- Flowflex
COVID-19 Antigen Rapid Test (ACON Laboratories, Inc.)
Updated Emergency Use Authorizations
- ASSURE-100
Rapid COVID-19 Test (Oceanit Foundry LLC)
- Lucira
CHECK-IT COVID-19 Test Kit (Lucira Health, Inc.)
Reissued Emergency Use Authorizations
- cobas
MPXV for use on the cobas 6800/8800 Systems (cobas MPXV) (Roche
Molecular Systems, Inc.)
- Pilot
COVID-19 At-Home Test (SD Biosensor, Inc.)
Revised Emergency Use Authorizations
- Allplex
2019-nCoV Assay (Seegene, 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)
CDRH
Learn
- Postmarket Activities - Risk Basics for Medical Devices (New
Module)
- Postmarket Activities - Application of Risk Management Principles
for Medical Devices (New Module)
- How to Study and Market Your Device - Post-Approval Study Requirements
and Postmarket Surveillance under Section 522 of the Federal Food,
Drug, and Cosmetic Act, Final Guidances (Updated Module)
|
|
December 14, 2022
Revised Emergency Use Authorization
- Quest
Diagnostics Monkeypox Virus Qualitative Real-Time PCR (Quest Diagnostics
Nichols Institute)
Digital
Health Policy Navigator (Updated)
- Step
6: Is the Software Function Intended to Provide Clinical Decision
Support? (Updated)
Monkeypox
and Medical Devices: Lists of Laboratories Offering Notified Laboratory-Developed
Monkeypox Tests (Updated)
Understanding
At-Home OTC COVID-19 Antigen Diagnostic Test Results
|
|
December 13, 2022
CDRH
Learn (Updated)
- Specialty Technical Topics - Targeted Box and Blocks Test (tBBT)
SARS-CoV-2
Viral Mutations: Impact on COVID-19 Tests: Clip COVID Rapid Antigen
Test (Luminostics, Inc.)
ASCA-Accredited
Testing Laboratories (Updated)
|
|
December 12, 2022
Revised Emergency Use Authorization
- 1copy
COVID-19 qPCR Multi Kit (1drop Inc.)
Transcript
and Presentation: COVID-19 and and Monkeypox Test Development and
Validation Virtual Town Hall Series - November 30, 2022
Medical
Gloves for COVID-19 (Updated)
Medical
Device Shortages During the COVID-19 Public Health Emergency (Updated)
Supplies
of Medical Devices for COVID-19: Frequently Asked Questions (Updated)
Federal
Register: Agency Information Collection Activities; Submission
for Office of Management and Budget Review; Comment Request; Quality
System Regulation
|
| December 9, 2022
Class
I Recall: Remel, Inc Recalls Thermo Scientific Gram Negative IVD
AST Sensititre Plate for risk of potential false susceptible results
CDRH
Learn (Updated)
- November 2022 Industry Basics Workshop: Understanding Risk with
Medical Devices
|
|
December 8, 2022
Chocolate
Touch Paclitaxel Coated PTA Ballon Catheter - P210039 (TriReme Medical,
LLC)
Content
of Human Factors Information in Medical Device Marketing Submissions
- Draft Guidance for Industry and Food and Drug Administration Staff
Voluntary
Malfunction Summary Reporting (VMSR) Program for Manufacturers -
Draft Guidance for Industry and Food and Drug Administration Staff
Class
I Recall: Dewei Medical Equipment Co. Recalls DNA/RNA Preservation
Kits That Are Not Authorized, Cleared, or Approved by the FDA
Federal
Register: Content of Human Factors Information in Medical Device
Marketing Submissions
Federal
Register: Voluntary Malfunction Summary Reporting Program for
Manufacturers
|
|
December 7, 2022
New Emergency Use Authorization
- Diazyme
SARS-CoV-2 Neutralizing Antibody CLIA Kit (Diazyme Laboratories,
Inc.)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Virtual
Town Hall Series - Test Development and Validation During Public
Health Emergencies Monkey pox (mpox) and COVID-19 - 12/14/2022
Augmented
Reality and Virtual Reality in Medical Devices
Non-Invasive
Body Contouring Technologies
|
|
December 6, 2022
Revised Emergency Use Authorization
- ASSURE-100
Rapid COVID-19 Test (Oceanit Foundry LLC)
Revoked Emergency Use Authorizations
- Visby
Medical COVID-19 Point of Care Test (Visby Medical, Inc.)
- Visby
Medical COVID-19 (Visby Medical, Inc.)
Update
on Endologix AFX Endovascular AAA Graft Systems and Risk of Type
III Endoleak: FDA Safety Communication
VENTANA
FOLR1 (FOLR-2.1) RxDx Assay - P220006 (Ventana Medical Systems,
Inc.)
|
|
December 5, 2022
UPDATE:
Impella RP System Post-Approval Study Results and Updated Labeling
- Letter to Health Care Providers
Printable
Slides: Webinar – Final Guidances on Post-Approval Study Requirements
and Postmarket Surveillance under Section 522 of the Federal Food,
Drug, and Cosmetic Act
|
|
December 2, 2022
Updated Emergency Use Authorizations
- SalivaDirect
DTC Saliva Collection Kit (Yale School of Public Health, Department
of Epidemiology of Microbial Diseases)
- SalivaDirect
At-Home Collection Kit (Yale School of Public Health, Department
of Epidemiology of Microbial Diseases)
Getinge
Maquet/Datascope Intra-Aortic Balloon Pump (IABP) Shortage - Letter
to Health Care Providers
Getinge’s
Maquet/Datascope IABP Devices: Update on Device Failure – Letter
to Health Care Providers (Updated)
Medical
Device Shortages During the COVID-19 Public Health Emergency (Updated)
MedSun
Newsletter, December 2022
Medical
Device Accessory Classification Request Granting Decisions (Updated)
List
of Cleared or Approved Companion Diagnostic Devices (In Vitro and
Imaging Tools) (Updated)
|
|
December 1, 2022
Revoked Emergency Use Authorization
- MD
Anderson High-throughput SARS-CoV-2 RT-PCR Assay (University of
Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory)
Webinar
- Final Guidances on Post-Approval Study Requirements and Postmarket
Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic
Act - December 6, 2022
Recalls
Related to the HVAD System (Updated)
|
| November 30, 2022
Federal
Register: Voting Members on a Public Advisory Committee; Technical
Electronic Product Radiation Safety Standards Committee
|
|
November 29, 2022
EUA
Template for Developers of Antigen Diagnostic Tests
EUA
Summary Template for Developers of Antigen Diagnostic Tests for
Monkeypox
Avive
Automated External Defibrillator (AED) and Accessories - P210015
(Avive Solutions, Inc.)
ASCA-Accredited
Testing Laboratories (Updated)
CDRH
Petitions (Updated)
Extended
Expiration Date for Flowflex COVID-19 Antigen Home Test
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190022,
DEN200015, DEN200016, DEN200055, and DEN200066 added)
|
|
November 28, 2022
The
Spanner Temporary Prostatic Stent - P060010/S013 (SRS Medical Systems,
Inc.)
Delisted Emergency Use Authorization
- SARS-Cov-2
Assay (Diagnostic Molecular Laboratory - Northwestern Medicine)
Medical
Device Development Tools (MDDT): CHemical RISk Calculator (CHRIS)
- Color Additives
|
| November 25, 2022
Revised Emergency Use Authorization
- DxLab
COVID-19 Test (DxLab Inc.)
|
|
November 23, 2022
Virtual
Town Hall Series - Test Development and Validation During Public
Health Emergencies (Monkeypox and COVID-19) - November 30, 2022
Class
I Recall: Baxter Hillrom Recalls WatchCare Incontinence Management
System (IMS) for Risk of RF Interference with Nearby Medical Equipment
|
|
November 22, 2022
New Emergency Use Authorizations
- CorDx
COVID-19 Ag Test (CorDx, Inc.)
- Fastep
COVID-19 Antigen Home Test (Azure Biotech Inc.)
- Lucira
COVID-19 & Flu Test (Lucira Health, Inc.)
Updated Emergency Use Authorizations
- BinaxNOW
COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.)
- Verily
COVID-19 RT-PCR Test (Verily Life Sciences)
Update:
Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP
Machines Recalled Due to Potential Health Risks: FDA Safety Communication
FAQs
on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine
Recalls (Updated)
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
|
|
November 21, 2022
New Emergency Use Authorization
- Diversified
Medical Healthcare SARS-CoV-2 Assay (Premier Medical Laboratory
Services)
Updated Emergency Use Authorization
- Flowflex
COVID-19 Antigen Home Test (ACON Laboratories, Inc)
- Hotgen
COVID-19 Antigen Home Test (Beijing Hotgen Biotech Co., Ltd.)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190020,
DEN190056, DEN200059, DEN210003, and DEN210013 added)
|
| November 18, 2022
New Emergency Use Authorization
- Hotgen
COVID-19 Antigen Home Test (Beijing Hotgen Biotech Co., Ltd.)
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
Automated
External Defibrillators (AEDs) (Updated)
Monkeypox
and Medical Devices (Updated)
Hearing
Aids (Updated)
|
|
November 17, 2022
New Emergency Use Authorization
- NIDS
COVID-19 Antigen Home Test (ANP Technologies, Inc.)
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
At-Home
COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative
Results: FDA Safety Communication (Updated)
At-Home
COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated)
Legacy
Identification Number (NDC/NHRIC): Frequently Asked Questions (Updated)
MDUFA
IV Performance Report - November 16, 2022
October
2022 Device Approval List
Automated
External Defibrillators (AEDs) (Updated)
Medtronic
HeartWare Ventricular Assist Device (HVAD) System (Updated)
Summary
Minutes for October 26-27, 2022 General and Plastic Surgery Devices
Panel of the Medical Devices Advisory Committee Meeting
Update:
Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP
Machines Recalled Due to Potential Health Risks: FDA Safety Communication
(Updated)
FAQs
on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine
Recalls (Updated)
|
|
November 16, 2022
Updated Emergency Use Authorizations
- RealStar
SARS-CoV02 RT-PCR Kits U.S. (altona Diagnostics GmbH)
- Lucira
COVID-19 All-In-One Test Kit (Lucira Health, Inc.)
Class
I Recall - Insulet Recalls Omnipod DASH Insulin Management System's
Personal Diabetes Manager (PDM)
|
|
November 15, 2022
New Emergency Use Authorization
- cobas
MPXV for use on the cobas 6800/8800 Systems (cobas MPXV) (Roche
Molecular Systems, Inc.)
Cybersecurity
(Updated)
Public
Workshop - Appropriate Use of Consensus Standards, Dec. 7, 2022
Standards
and Conformity Assessment Program (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190031,
DEN190042, DEN200006, DEN200018, DEN200042, and DEN200044 added)
|
|
November 14, 2022
Voluntary
eSTAR Program (Updated)
Monkeypox
and Medical Devices (Updated)
|
| November 10, 2022
Revised Emergency Use Authorizations
- UOL
COVID-19 Test (Uh-Oh Labs Inc.)
- Amplitude
Solution with the TaqPath COVID-19 High-Throughput Combo Kit (Thermo
Fisher Scientific Inc.)
Referencing
the Definition of "Device" in the Federal Food, Drug,
and Cosmetic Act in Guidance, Regulatory Documents, Communications,
and Other Public Documents - Guidance for Industry and Food and
Drug Administration Staff
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
CDRH
Petitions (Updated)
|
|
November 9, 2022
New Emergency Use Authorization
- The
Nano Test for COVID-19 (Nanobiosym Precision Testing Services)
Updated Emergency Use Authorizations
- Xpert
Xpress CoV-2 plus (Cepheid)
|
|
November 8, 2022
New Emergency Use Authorization
- Rize
Laboratory SARS nCoV-2019 Multiplexed Assay (Rize Laboratory)
Meeting
Materials for November 10, 2022 Ophthalmic Devices Panel of the
Medical Devices Advisory Committee Meeting
|
|
November 7, 2022
Updated Emergency Use Authorizations
- Celltrion
DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.)
- Celltrion
DiaTrust COVID-19 Ag Home Test (Celltrion USA, Inc.)
Summary
Minutes: October 20, 2022 Clinical Chemistry and Clinical Toxicology
Devices Panel of the Medical Devices Advisory Committee Meeting
24
Hour Summary and Presentations: November 1, 2022 Anesthesiology
and Respiratory Therapy Devices Panel of the Medical Devices Advisory
Committee Meeting
Pulse
Oximeter Accuracy and Limitations: FDA Safety Communication (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200005
and DEN210014 added)
CDRH
Statement: CDRH Hosts Workshop in Partnership with NIH, Continues
Commitment to Advance Medical Device Innovation to Help Mitigate
Opioid Crisis
CDRH
Petitions (Updated)
|
|
November 4, 2022
Revised Emergency Use Authorizations
- Pixel
by LabCorp COVID-19 Test Home Collection Kit (Laboratory Corporation
of America (LabCorp))
- BioGX
Xfree COVID-19 Direct RT-PCR (BioGX, Inc.)
Updated Emergency Use Authorizations
- OPTI
SARS-CoV-2 RT PCR Test (OPTI Medical Systems, Inc.)
- PhoenixDx
SARS-CoV-2 Multiplex (Trax Management Services Inc.)
Virtual
Town Hall Series - Test Development and Validation During Public
Health Emergencies (Monkeypox and COVID-19) - November 9, 2022
Activities
to Support Medical Device Innovators (Updated)
|
|
November 3, 2022
CDRH
Petitions (Updated)
Do
Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical
Condition: FDA Safety Communication
CDRH
Learn (Updated)
- Specialty Technical Topics - Presentation and Transcript: Clinical
Decision Support Software Final Guidance - October 18, 2022
- In Vitro Diagnostics - Presentation and Transcript: COVID-19 and
and Monkeypox Test Development and Validation Virtual Town Hall
Series - October 26, 2022
|
|
November 2, 2022
Monkeypox
and Medical Devices (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN220024
added)
|
|
November 1, 2022
MQSA
National Statistics (Updated)
In
Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2
(Updated)
Class
I Recall: Teleflex Recalls Iso-Gard Filter S for Risk of Splitting
or Detaching That May Cause Leakage and Insufficient Air Supply
to Patients
24
Hour Summary and Presentations for October 26-27, 2022 General and
Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
meeting
Federal
Register: Testing Communications by the Food and Drug Administration's
Center for Devices and Radiological Health
|
|
October 31, 2022
Consider
Alternatives for MRI-Guided Breast Biopsy Grid Plates Due to Shortage
- Letter to Health Care Providers
Reuse
Tracheostomy Tubes or Switch to Appropriate Alternatives During
Shortage: FDA Safety Communication
Medical
Device Shortages During the COVID-19 Public Health Emergency (Updated)
MedSun
Newsletter - November 2022
|
| October 28, 2022
COVID-19
Test Development and Review: FAQs on Testing for SARS-CoV-2 (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Potential
Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis
Machines Manufactured by Fresenius Medical Care - Letter to Health
Care Providers (Updated)
Meeting
Materials for November 1, 2022 Anesthesiology and Respiratory Therapy
Devices Panel of the Medical Devices Advisory Committee
Virtual
Public Workshop - CDRH Industry Basics: Understanding Risk with
Medical Devices - November 15, 2022
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200046,
DEN210024 and DEN210034 added)
|
|
October 27, 2022
Revised Emergency Use Authorizations
- cobas
SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the
cobas Liat System (Roche Molecular Systems, Inc.)
- cobas
SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas
SARS-CoV-2) (Roche Molecular Systems, Inc.)
Updated Emergency Use Authorizations
- Omnia
SARS-CoV-2 Antigen Test (Qorvo Biotechnologies, LLC.)
- Atellica
IM SARS-CoV-2 Antigen (CoV2Ag) (Siemens Healthcare Diagnostics,
Inc.)
- ADVIA
Centaur SARS-CoV-2 Antigen (CoV2Ag) (Siemens Healthcare Diagnostics,
Inc.)
- Bio-Rad
Reliance SARS-CoV-2 RT-PCR Assay Kit (Bio-Rad Laboratories, Inc.)
- TaqPath
COVID-19 RNase P Combo Kit 2.0 (Thermo Fisher Scientific Inc.)
Third
Party Review Organization Performance Report - FY2022, Q4
Digital
Health Research and Partnerships
|
|
October 26, 2022
Developing
and Responding to Deficiencies in Accordance with the Least Burdensome
Provisions - Guidance for Industry and Food and Drug Administration
Staff (Updated)
Table
of Pharmacogenetic Associations (Updated)
|
|
October 25, 2022
Do
Not Use Certain Mighty Bliss Electric Heating Pads Due to Risk of
Injury: FDA Safety Communication
24
Hour Summary and Presentations for October 20, 2022 Clinical Chemistry
and Clinical Toxicology Devices Panel of the Medical Devices Advisory
Committee Meeting
|
|
October 24, 2022
Consumer
Information on: PATHWAY anti-HER2/neu Rabbit Monoclonal Primary
Antibody - P990081/S047 (Ventana Medical Systems, Inc.)
Consumer
Information on: Oncomine Dx Target Test - P160045/S031 (Life Technologies
Corporation)
Meeting
Materials: October 26-27, 2022 General and Plastic Surgery Devices
Panel of the Medical Devices Advisory Committee Meeting
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
|
| October 21, 2022
Updated Emergency Use Authorizations
- iHealth
COVID-19 Antigen Rapid Test (iHealth Labs, Inc.)
|
|
October 20, 2022
Updated Emergency Use Authorizations
- SelfCheck
cobas SARS-CoV-2 Assay (Cleveland Clinic Robert J. Tomsich Pathology
and Laboratory Medicine Institute)
- NxTAG
CoV Extended Panel Assay (Luminex Molecular Diagnostics, Inc.)
- CareStart
COVID-19 Antigen Home Test (Access Bio, Inc.)
Revoked Emergency Use Authorizations
- Cleveland
Clinic SARS-CoV-2 Assay (Cleveland Clinic Robert J. Tomsich Pathology
and Laboratory Medicine Institute)
- SelfCheck
COVID-19 TaqPath Multiplex PCR (Cleveland Clinic Robert J. Tomsich
Pathology and Laboratory Medicine Institute)
Select
Updates for the Breakthrough Devices Program Guidance: Reducing
Disparities in Health and Health Care - Draft Guidance for Industry
and Food and Drug Administration Staff
Consumer
Information on: LungFit PH - P200044 (Beyond Air, Inc.)
FDA
Provides Lists of Laboratories Offering Notified Laboratory-Developed
Monkeypox Tests
|
|
October 19, 2022
Revised Emergency Use Authorization
- Rapid
SARS-CoV-2 Antigen Test Card (Xiamen Boson Biotech Co., Ltd.)
Legacy
Identification Number (NDC/NHRIC): Frequently Asked Questions
UPC
Alternatives UDI-A160001 and UDI-A160002: Frequently Asked Questions
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200050
and DEN200069 added)
|
|
October 18, 2022
New Emergency Use Authorization
- Metrix
COVID-19 Test (Aptitude Medical Systems Inc.)
Revised Emergency Use Authorization
- Pilot
COVID-19 At-Home Test (SD Biosensor, Inc.)
CDRH
Proposed Guidance Development
CDRH
Proposed Guidances for Fiscal Year 2023 (FY2023)
Meeting
Materials for October 20, 2022 Clinical Chemistry and Clinical Toxicology
Devices Panel of the Medical Devices Advisory Committee
|
|
October 17, 2022
Medtronic
HeartWare Ventricular Assist Device (HVAD) System (Updated)
FDA's
Activities: Urogynecologic Surgical Mesh (Updated)
Printable
Slides: Webinar - Clinical Decision Support Software Final Guidance
- October 18, 2022
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200046
and DEN210027 added)
|
| October 14, 2022
Updated Emergency Use Authorization
- CLINITEST
Rapid COVID-19 Antigen Self-Test (Siemens Healthineers)
|
| October 13, 2022
Updated Emergency Use Authorizations
- CLINITEST
Rapid COVID-19 Antigen Self-Test (Siemens Healthineers)
- NeoPlex
COVID-19 Detection Kit (GeneMatrix, Inc.)
- Xpert
Xpress SARS-CoV-2 DoD (Cepheid)
- AvellinoCoV2
test (Avellino Lab USA, Inc.)
PASCAL
Precision Transcatheter Valve Repair System - P220003 (Edward Lifesciences,
LLC)
Webinar
- Computer Software Assurance for Production and Quality System
Software Draft Guidance - October 27, 2022
Federal
Register: Request for Nominations for Individuals and Consumer Organizations
for Advisory Committees
|
|
October 12, 2022
Class
I Recall: Jiangsu Well Biotech Co., Ltd. Recalls COVID-19 Ag Rapid
Test Devices That Are Not Authorized, Cleared, or Approved by the
FDA
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN210005
added)
MedSun
Newsletters (October 2022)
|
|
October 11, 2022
CDRH
Statement: CDRH Launches the Total Product Life Cycle Advisory Program
Pilot
Cybersecurity:
Tips for Clinicians - Keeping Your Patients’ Connected Medical
Devices Safe
|
|
October 7, 2022
New Emergency Use Authorization
- Alinity
m MPXV (Abbott Molecular, Inc.)
Revised Emergency Use Authorization
- Quest
COVID-19 PCR DTC (Quest Diagnostics Nichols Institute)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
November
10, 2022: Ophthalmic Devices Panel of the Medical Devices Advisory
Committee Meeting Announcement
LASIK
(Updated)
Federal
Register: Guidance: Laser-Assisted In Situ Keratomileusis Lasers--Patient
Labeling Recommendations
|
|
October 6, 2022
Updated Emergency Use Authorizations
- ID
NOW Covid-19 2.0 (Abbott Diagnostics Scarborough)
- Clip
COVID Rapid Antigen Test (Luminostics, Inc.)
- Rapid
SARS-CoV-2 Antigen Test Card (Xiamen Boson Biotech Co., Ltd.)
- OHC
COVID-19 Antigen Self Test (OSANG LLC)
- Speedy
Swab Rapid COVID-19 Antigen Self-Test (Watmind USA)
FDA
Activities Related to Essure (Updated)
Information
for Patients and Health Care Providers: Essure (Updated)
October
26-27, 2022: General and Plastic Surgery Devices Panel of the Medical
Devices Advisory Committee Meeting Announcement
Postmarket
Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic
Act - Guidance for Industry and Food and Drug Administration Staff
522
Postmarket Surveillance Studies Program (Updated)
Procedures
for Handling Post-Approval Studies Imposed by PMA Order - Guidance
for Industry and Food and Drug Administration Staff
Post-Approval
Studies Program (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200017
and DEN200041 added)
|
|
October 5, 2022
Medical
Device User Fee Amendments (MDUFA) | FDA
Device
Registration and Listing | FDA
User
Fees and Refunds for De Novo Classification Requests
User
Fees and Refunds for Premarket Approval Applications and Device
Biologics License Applications
User
Fees and Refunds for Premarket Notification Submissions (510(k)s)
User
Fees and Refunds for 513(g) Requests for Information
Aptima
CMV Quant Assay (Hologic, Inc.) - P210029
At-Home
OTC COVID-19 Diagnostic Tests (Extended Expiration Date for QuickVue
At-Home OTC COVID-19 Test)
Artificial
Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
(Updated)
MQSA
National Statistics (Updated)
|
|
October 4, 2022
Appendix
B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator
Accessories (Updated)
Transcript,
Presentation, and Slides: COVID-19 and and Monkeypox Test Development
and Validation Virtual Town Hall Series - September 28, 2022
|
|
October 3, 2022
IC-8
Apthera Intraocular Lens (AcuFocus, Inc.) - P210005
Updated Emergency Use Authorization
- Lyra
SARS-CoV-2 Assay (Quidel Corporation)
eCopy
Medical Device Submissions (Updated)
Send
and Track Medical Device Premarket Submissions Online: CDRH Portal
(Updated)
Voluntary
eSTAR Program (Updated)
FDA
and Industry Actions on De Novo Classification Requests: Effect
on FDA Review Clock and Goals
FDA
and Industry Actions on Premarket Notification (510(k)) Submissions:
Effect on FDA Review Clock and Goals
FDA
and Industry Actions on Premarket Approval Applications (PMAs):
Effect on FDA Review Clock and Goals
|
| September 30, 2022
LivaNova
(TandemLife) Recalls LifeSPARC System for Risk of Unintentional
Extended Pump Stop During Controller Critical Failure
Medical
Devices and Radiation-Emitting Products Committee Vacancies (Updated)
Roster
for the Ophthalmic Devices Panel (Updated)
Roster
of the Immunology Devices Panel (Updated)
Roster
of the Medical Devices Dispute Resolution Panel (Updated)
Roster
of the Anesthesiology and Respiratory Therapy Devices Panel (Updated)
|
|
September 29, 2022
Virtual
Town Hall Series - Test Development and Validation (COVID-19 and
Monkeypox) - September 28, 2022 (Updated)
Joint
Public Workshops - Medical Devices for Opioid Use
NeVa
VS - H210004 (Versalio)
Oncomine
Dx Target Test - P160045/S035
Revised Emergency Use Authorization
- SCoV-2
Ag Detect Rapid Self-Test (InBios International Inc.)
Device
Software Functions Including Mobile Medical Applications (Updated)
Examples
of Device Software Functions the FDA Regulates (Updated)
Examples
of Software Functions That Are NOT Medical Devices (Updated)
Examples
of Software Functions for Which the FDA Will Exercise Enforcement
Discretion (Updated)
How
to Determine if Your Product is a Medical Device (Updated)
Digital
Health Terms (Updated)
Ask
a Question About Digital Health Regulatory Policies (Updated)
|
|
September 28, 2022
Revised Emergency Use Authorization
- QuickVue
At-Home OTC COVID-19 Test (Quidel Corporation)
Catalog
of Regulatory Science Tools to Help Assess New Medical Devices
Public
Workshop - Expediting Innovation of Bioelectronic Implants for Vision
Restoration - 10/24/2022 (Updated)
CDRH
Learn: Specialty Technical Topics (Updated)
- Presentation and Transcript: Policy for Monkeypox Tests, Session
2 - September 21, 2022
|
|
September 27, 2022
Policy
for Coronavirus Disease-2019 Tests During the Public Health Emergency
(Revised) - Guidance for Developers and Food and Drug Administration
Staff
COVID-19
Test Uses: FAQs on Testing for SARS-CoV-2 (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
FAQs
on Testing for SARS-CoV-2 (Updated)
COVID-19
Test Development and Review: FAQs on Testing for SARS-CoV-2 (Updated)
Webinar
- Clinical Decision Support Software Final Guidance - October 18,
2022
Clinical
Decision Support Software - Guidance for Industry and Food and Drug
Administration Staff
- Graphic: Your
Clinical Decision Support Software: Is It a Medical Device?
Digital
Health Policy Navigator
Policy
for Device Software Functions and Mobile Medical Applications -
Guidance for Industry and Food and Drug Administration Staff (Updated)
Medical
Device Data Systems, Medical Image Storage Devices, and Medical
Image Communications Devices - Guidance for Industry and Food and
Drug Administration Staff (Updated)
Clinical
Performance Assessment: Considerations for Computer-Assisted Detection
Devices Applied to Radiology Images and Radiology Device Data in
Premarket Notification (510(k)) Submissions - Guidance for Industry
and Food and Drug Administration Staff (Updated)
Computer-Assisted
Detection Devices Applied to Radiology Images and Radiology Device
Data - Premarket Notification [510(k)] Submissions (Updated)
Display
Devices for Diagnostic Radiology - Guidance for Industry and Food
and Drug Administration Staff (Updated)
List
of Cleared or Approved Companion Diagnostic Devices (In Vitro and
Imaging Tools) (Updated)
Federal
Register: Clinical Chemistry and Clinical Toxicology Devices Panel
of the Medical Devices Advisory Committee; Notice of Meeting; Establishment
of a Public Docket; Request for Comments; Amendment of Notice
Federal
Register: Policy for Coronavirus Disease-2019 Tests During the Public
Health Emergency (Revised)
Federal
Register: Guidance - Clinical Decision Support Software
|
|
September 26, 2022
Digital
Health Software Precertification (Pre-Cert) Pilot Program
|
| September 23, 2022
Philips
Respironics Recalls Certain BiPAP Machines for Plastic Issue that
May Expose Patients to Certain Chemicals of Concern
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
September 22, 2022
Revoked Emergency Use Authorization
- Laboratorio
Clinico Toledo SARS-CoV-2 Assay (Laboratorio Clinico Toledo)
Revised Emergency Use Authorization
- TaqPath
COVID-19 RNase P Combo Kit 2.0 (Thermo Fisher Scientific Inc.)
Virtual
Town Hall Series - Test Development and Validation (COVID-19 and
Monkeypox) - September 28, 2022
|
|
September 21, 2022
Electronic
Submission Template for Medical Device 510(k) Submissions - Guidance
for Industry and Food and Drug Administration Staff
eCopy
Program for Medical Device Submissions (Updated)
Tracking
Your Premarket Submission's Progress (Progress Tracker) (Updated)
Office
of Product Evaluation and Quality (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN220025
added)
|
|
September 20, 2022
Information
on Cybersecurity (Updated)
Medical
Device Development Tools (MDDT) (Updated)
|
|
September 19, 2022
Virtual
Town Hall Series - Monkeypox Test Development and Validation (Updated)
CDRH
Learn: Specialty Technical Topics (Updated)
- Presentation and Transcript: Monkeypox Test Development and Validation
Webinar - September 14, 2022
|
| September 16, 2022
Revised Emergency Use Authorization
- LumiraDx
SARS-CoV-2 RNA STAR Complete (LumiraDx UK Ltd.)
- Lyra
SARS-CoV-2 Assay (Quidel Corporation)
ASCA-Accredited
Testing Laboratories (Updated)
Recommendations
for Certain Medtronic Electromyogram Endotracheal Tubes and Risk
of Airway Obstruction – Letter to Health Care Providers
|
|
September 15, 2022
Re-issued Emergency Use Athorizations
- Quest
Diagnostics Monkeypox Virus Qualitative Real-Time PC (Quest Diagnostics
Nichols Institute)
Class
I Recall: Baxter Healthcare Corporation Recalls Clearlink Basic
Solution Set with Duovent for Risk of Leaks That May Expose Providers
and Patients to Hazardous / Toxic Substances
Pulse
Oximeter Accuracy and Limitations: FDA Safety Communication (Updated)
|
|
September 14, 2022
Re-issued Emergency Use Authorizations
- Predicine
SARS-CoV-2 RT-PCR Test (Predicine, Inc.)
- Rheonix
COVID-19 MDx Assay (Rheonix, Inc.)
Webinar
on the Policy for Monkeypox Tests (Updated)
SARS-CoV-2
Viral Mutations: Impact on COVID-19 Tests (Updated)
|
|
September 13, 2022
At-Home
OTC COVID-19 Diagnostic Tests (Extended Expiration Dates for Flowflex
COVID-19 Antigen Home Test)
Co-sponsored
Public Workshop - Expediting Innovation of Bioelectronic Implants
for Vision Restoration (Updated Agenda)
Guardant360
CDx - P200010/S008
ARCHITECT
HBsAg NEXT Qualitative Reagent Kit - P210003
|
|
September 12, 2022
Computer
Software Assurance for Production and Quality System Software -
Draft Guidance for Industry and Food and Drug Administration Staff
Class
I Recall: Medtronic Xomed Recalls NIM CONTACT Reinforced EMG Endotracheal
Tube and the NIM Standard Reinforced EMG Endotracheal Tube for Risk
of Airway Obstruction
Federal
Register: Computer Software Assurance for Production and Quality
System Software; Draft Guidance for Industry and Food and Drug Administration
Staff; Availability
Federal
Register: Policy for Monkeypox Tests To Address the Public Health
Emergency; Guidance for 4164-01-P Laboratories, Commercial Manufacturers,
and Food and Drug Administration Staff; Availability
|
| September 9, 2022
FAQs
on Testing for Monkeypox
Webinar
on the Policy for Monkeypox Tests - September 14, 2022
FAQs
on Viral Transport Media During COVID-19 (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
September 8, 2022
Reports
of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around
Implants: FDA Safety Communication
Abbott
MitraClip Device: Potential for Clip Lock Malfunctions - Letter
to Health Care Providers
Federal
Register: Emergency Use Authorization - In Vitro Diagnostic Devices
for Detection and/or Diagnosis of COVID-19; Revocation
|
|
September 7, 2022
New Emergency Use Authorization
- Quest
Diagnostics Monkeypox Virus Qualitative Real-Time PCR
Monkeypox
and Medical Devices
Monkeypox
Emergency Use Authorizations for Medical Devices
Policy
for Monkeypox Tests to Address the Public Health Emergency - Guidance
for Laboratories, Commercial Manufacturers and Food and Drug Administration
Staff
Summary
Minutes: July 12-13, 2022 Patient Engagement Advisory Committee
Meeting
|
|
September 6, 2022
Revised Emergency Use Authorization
- TaqPath
COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
- Rapid
SARS-CoV-2 Antigen Test Card (Xiamen Boson Biotech Co., Ltd.)
- Flowflex
COVID-19 Antigen Home Test (ACON Laboratories, Inc.)
- LumiraDx
SARS-CoV-2 Ab Test (LumiraDx UK Ltd.)
Updated Emergency Use Authorization
- SARS-CoV-2
real time RT-PCR test (Authorized by HHS/OASH) (University of Louisville
Infectious Diseases Laboratory)
Certain
Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due
to Safety Issue with Magnets That May Affect Certain Medical Devices:
FDA Safety Communication
Certain
Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due
to Safety Issue with Magnets That May Affect Certain Medical Devices:
Letter to Health Care Providers
Personal
Protective Equipment EUAs (Updated)
Mammography
Facility Adverse Event and Action Report – September 6, 2022:
Memorial MRI & Diagnostic, LLC
Mammography
Facility Adverse Event and Action Report – September 6, 2022:
Ste. Genevieve County Memorial Hospital
|
|
September 2, 2022
Transcript
and Presentation: Coronavirus (COVID-19) Test Development and Validation
Virtual Town Hall Series - August 24, 2022
|
|
September 1, 2022
At-Home
OTC COVID-19 Diagnostic Tests (Extended Expiration Dates for OHC
COVID-19 Antigen Self Test and CareStart COVID-19 Antigen Home Test)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN210052
added)
MQSA
National Statistics (Updated)
|
| August 31, 2022
Class
I Recall: Integra Recalls CereLink ICP Monitor for Risk of Incorrect
Intracranial Pressure Readings
MedSun
Newsletter, September 2022 (PDF - 4MB)
|
|
August 30, 2022
Revised Emergency Use Authorizations
- Elecsys
Anti-SARS-CoV-2 S (Roche Diagnostics, Inc.)
- CareStart
COVID-19 Antigen Home Test (Access Bio, Inc.)
- Genabio
COVID-19 Rapid Self-Test Kit (Genabio Diagnostics Inc.)
- NIDS
COVID-19 Antigen Rapid Test Kit (ANP Technologies, Inc.)
- BioCode
CoV-2 Flu Plus Assay (Applied BioCode, Inc.)
- MicroGEM
Sal6830 SARS-CoV-2 Saliva Test (MicroGEM U.S., Inc.)
Revoked Emergency Use Authorizations
- Talis
One COVID-19 Test System (Talis Biomedical Corporation)
Updated Emergency Use Authorizations
- SARS-CoV-2
Assay (Nationwide Children's Hospital)
Transcript
for: July 12-13, 2022 Patient Engagement Advisory Committee Meeting
Transcript
for: July 28-29, 2022 General and Plastic Surgery Devices Panel
of the Medical Devices Advisory Committee Meeting
|
|
August 29, 2022
Certain
Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue:
FDA Safety Communication
Class
I Recall: Intera Oncology Recalls Intera 3000 Hepatic Artery Infusion
Pump Due to Faster Than Expected Flow Rates That May Impact Infusion
Delivery
Class
I Recall: Hamilton Medical AG Recalls Hamilton-C6 Intensive Care
Ventilator Due to Potential Water Ingress that May Cause Breathing
Support to Stop
|
| August 26, 2022
Medical
Device Shortages During the COVID-19 Public Health Emergency (Updated)
3D
Printing of Medical Devices, Accessories, Components, and Parts
During the COVID-19 Pandemic (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
August 25, 2022
Call
I Recall: Medtronic Recalls HeartWare HVAD System Batteries for
Electrical Faults That Cause Battery Failure
Consumer
Information on: Stellarex 0.035 OTW Drug-coated Angioplasty Ballon
- P160049/S015
Medtronic
HeartWare Ventricular Assist Device (HVAD) System (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200039
added)
Transcripts for:
- Virtual
Public Workshop – Study Design Considerations for Transbronchoscopic
Thermal Ablation Devices for the Treatment of Oligometastases to
the Lung
- Virtual
Public Workshop – Animal Studies for Orthopedic Products -
06/02/2022
-
Virtual Public Workshop - Building Medical Device Supply Chain Resilience:
A Healthcare and Public Health Ecosystem-Wide Collaboration - 06/07/2022
Federal
Register: Authorization and Revocations of Emergency Use of Certain
In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19
|
|
August 24, 2022
List
of Cleared or Approved Companion Diagnostic Devices (In Vitro and
Imaging Tools) (Updated)
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Export of Medical Devices; Foreign Letters of Approval
|
|
August 23, 2022
Consumer
Information on: BioFreedom Drug Coated Coronary Stent (DCS) System
– P190020
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Medical Device Labeling Regulations
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Medical Devices; Humanitarian Use Devices
|
|
August 22, 2022
Reissued Emergency Use Authorization
- Accula
SARS-CoV-2 Test (Mesa Biotech Inc.)
Revised Emergency Use Authorizations
- LumiraDx
SARS-CoV-2 RNA STAR Complete (LumiraDx UK Ltd.)
- OHC
COVID-19 Antigen Self Test (OSANG LLC)
- SelfCheck
cobas SARS-CoV-2 + Flu Assay (Cleveland Clinic Robert J. Tomsich
Pathology and Laboratory Medicine Institute)
- Detect
Covid-19 Test (Detect Inc.)
EUA
Authorized Serology Test Performance (Updated)
eMDR
- eMDR
System Enhancements (Updated)
- Coding
Resources for Medical Device Reports (Updated)
- Health
Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files
(Updated)
|
| August 19, 2022
Class
I Recall: Medtronic Recalls Cobalt XT, Cobalt and Crome ICDs and
CRT-Ds for Risk that Devices May Issue a Short Circuit Alert and
Deliver Reduced Energy Shock During High Voltage Therapy
At-Home
OTC COVID-19 Diagnostic Tests (Extended Expiration Dates for Lucira
CHECK-IT COVID-19 Test Kit and InteliSwab COVID-19 Rapid Test)
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Center for Devices and Radiological Health Appeals
Processes
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Current Good Manufacturing Practice; Quality System
Regulation
|
|
August 17, 2022
Stop
Using Certain Syringes and Needles with Needle Safety Devices Manufactured
by Haiou – Letter to Health Care Providers (Updated)
|
|
August 16, 2022
Regulatory
Requirements for Hearing Aid Devices and Personal Sound Amplification
Products - Guidance for Industry and Food and Drug Administration
Staff
Information
on Hearing Aids (Updated)
Hydrogen
Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations
- Premarket Notification (510(k)) Submissions - Draft Guidance for
Industry and Food and Drug Administration Staff
Replacement
Reagent and Instrument Family Policy for In Vitro Diagnostic Devices
- Guidance for Industry and FDA Staff
Consumer
Information on: JUVÉDERM VOLUX XC - P110033/S065
Update:
Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP
Machines Recalled Due to Potential Health Risks: FDA Safety Communication
(Updated)
FAQs
on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine
Recalls (Updated)
Federal
Register: Regulatory Requirements for Hearing Aid Devices and Personal
Sound Amplification Products; Guidance for Industry and Food and
Drug Administration Staff; Availability
Federal
Register: Medical Devices: Ear, Nose, and Throat Devices; Establishing
Over-the-Counter Hearing Aids
|
|
August 15, 2022
Reissued Emergency Use Authorizations
- Gravity
Diagnostics COVID-19 Test Home Collection Kit (Gravity Diagnostics,
LLC)
- Gravity
Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits (Gravity Diagnostics,
LLC)
- GENETWORx
Covid-19 Nasal Swab Test (RCA Laboratory Services LLC dba GENETWORx)
- GenBody
COVID-19 Ag (GenBody Inc.)
Revised Emergency Use Authorizations
- cobas
SARS-COV-2 Nucleic acid test for use on the cobas Liat System (cobas
SARS-CoV-2) (Roche Molecular Systems, Inc.)
- cobas
SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the
cobas Liat System (Roche Molecular Systems, Inc.)
- Celltrion
DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.)
- INDICAID
COVID-19 Rapid Antigen Test (PHASE Scientific International, Ltd.)
- INDICAID
COVID-19 Rapid Antigen At-Home Test (PHASE Scientific International,
Ltd.)
|
| August 11, 2022
At-Home
COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative:
FDA Safety Communication
Becton
Dickinson Recalls Intraosseous Needle Set Kits, Intraosseous Manual
Driver Kits, and Intraosseous Powered Drivers for Issues That May
Cause Delayed Treatment Delivery
Consumer
Information on: SBL-3 Multifocal Intraocular Lens - P200020
Consumer
Information on: ADVIA Centaur HBc Total 2 (HBcT2), ADVIA Centaur
HBc Total 2 Quality Control (HBcT2 QC), Atellica IM HBc Total 2
(HBcT2), Atellica IM HBc Total 2 Quality Control (HBcT2 QC) - P210019
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Agreement for Shipment of Devices for Sterilization
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Medical Device Accessories
|
|
August 10, 2022
Color
Additives for Medical Devices (Updated)
|
|
August 9, 2022
Evaluation
of Automatic Class III Designation (De Novo) Summaries (Added DEN190039
and DEN200030)
Federal
Register: Mammography Quality Standards Act Requirements
Federal
Register: Food and Drug Administration Modernization Act: Modifications
to the List of Recognized Standards, Recognition List Number: 058
Haimen
Shengbang Laboratory Equipment Co. Ltd. Recalls Viral Transport
Media Containers That Are Not Authorized, Cleared, or Approved by
the FDA
|
|
August 8, 2022
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Q-Submission Program for Medical Devices
|
|
August 5, 2022
Updated Emergency Use Authorizations
- CLINITEST
Rapid COVID-19 Antigen Self-Test (Siemens Healthineer)
Mammography
Facility Adverse Event and Action Report - August 5, 2022: Elliott
Breast Clinic
Mammography
Facility Adverse Event and Action Report - August 5, 2022: Watson
Imaging Center
|
|
August 4, 2022
Revised Emergency Use Authorizations
- DASH
SARS-CoV-2/S Test (Minute Molecular Diagnostics, Inc.)
Breast
Implants (Updated)
Things
to Consider Before Getting Breast Implants (Updated)
Medical
Device Reports for Systemic Symptoms in Women with Breast Implants
(Updated)
Medical
Device Reports of Breast Implant-Associated Anaplastic Large Cell
Lymphoma (Updated)
Breast
Implants: Additional Resources (Updated)
CDRH’s
Experiential Learning Program - Submission Period Now Open
|
|
August 3, 2022
Revised Emergency Use Authorizations
- COVID-Flu
Multiplex Assay (Exact Sciences Laboratories)
- UOL
COVID-19 Test (Uh-Oh Labs Inc.)
- InteliSwab
COVID-19 Rapid Test (OraSure Technologies, Inc.)
- InteliSwab
COVID-19 Rapid Test Rx (OraSure Technologies, Inc.)
- InteliSwab
COVID-19 Rapid Test Pro (OraSure Technologies, Inc.)
SARS-CoV-2
Viral Mutations: Impact on COVID-19 Tests (Twist Bioscience)
In
Vitro Diagnostics EUAs - Other Tests for SARS-CoV-2 (Twist Biosciences)
Sterilization
for Medical Devices (Updated)
Transcript
and Presentation: Coronavirus (COVID-19) Test Development and Validation
Virtual Town Hall Series - July 27, 2022
Breakthrough
Devices Program (Updated)
|
|
August 2, 2022
New Emergency Use Authorizations
- Helix
Diagnostics SARS nCoV-2019 Multiplexed Assay (Helix Diagnostics)
Reissued Emergency Use Authorizations
- SARS-CoV-2
NGS Assay (Twist Bioscience Corporation)
MedSun
Newsletter: August 2022, Volume 22, Issue 8
MaximBio
ClearDetect COVID-19 Antigen Home Test (Extended Expiration Date)
Pruebas
de COVID-19 sin receta médica o de venta libre para diagnóstico
en el hogar: MaximBio ClearDetect COVID-19 Antigen Home Test (Extended
Expiration Date)
|
|
August 1, 2022
Revoked Emergency Use Authorizations
- BD
SARS-CoV-2/Flu for BD MAX System (Becton Dickenson and Company (BD))
Consumer
Information on: TactiCath Contact Force Ablation Catheter, Sensor
Enabled - P130026/S070
Class
I Recall: North American Diagnostics Recalls Oral Rapid SARS-CoV-2
Rapid Antigen Test Kits That Are Not Authorized, Cleared, or Approved
by the FDA
MQSA
National Statistics (Updated)
|
| July 29, 2022
Reissued Emergency Use Authorizations
- Predicine
SARS-CoV-2 RT-PCR Test (Predicine, Inc.)
- Revogene
SARS-CoV-2 (Meridian Bioscience, Inc.)
- Omnia
SARS-CoV-2 Antigen Test (Qorvo Biotechnologies, LLC.: For Qorvo
Biotechnologies, LLC.)
Revised Emergency Use Authorizations
- Labcorp
Seasonal Respiratory Virus RT-PCR Test (Laboratory Corporation of
America (Labcorp))
- Labcorp
Seasonal Respiratory Virus RT-PCR DTC Test (Laboratory Corporation
of America (Labcorp))
- Labcorp
SARS-CoV-2 & Influenza A/B Assay (Laboratory Corporation of
America (Labcorp))
- Lucira
CHECK-IT COVID-19 Test Kit (Lucira Health, Inc.)
- Lucira
COVID-19 All-In-One Test Kit (Lucira Health, Inc.)
|
|
July 28, 2022
Class
I Recall: Covidien, LLC (Medtronic) Recalls Palindrome and Mahurkar
Hemodialysis Catheters Due to Catheter Hub Defect
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN210032
added)
|
|
July 27, 2022
Laser-Assisted
In Situ Keratomileusis (LASIK) Lasers - Patient Labeling Recommendations
- Draft Guidance for Industry and Food and Drug Administration Staff
Updated
CDRH Learn Module: How to Get Your Electronic Product on the U.S.
Market
Federal
Register: Laser-Assisted In Situ Keratomileusis Lasers: Patient
Labeling Recommendations
|
|
July 26, 2022
Meeting
materials for July 28-29, 2022 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)
|
|
July 25, 2022
Reissued Emergency Use Authorizations
- Visby
Medical COVID-19 Point of Care Test (Visby Medical, Inc.)
- LumiraDx
SARS-CoV-2 Ag Test (LumiraDx UK Ltd.)
Revised Emergency Use Authorizations
- Color
COVID-19 Self-Swab Collection Kit (Color Health)
- PKamp
Respiratory SARS-CoV-2 RT-PCR Panel 1 (PerkinElmer, Inc)
- Nexus
High Throughput SARS-CoV-2 Assay (Nexus Medical Labs, LLC)
- QuickVue
At-Home OTC COVID-19 Test (Quidel Corporation)
- MaximBio
ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.)
- T-Detect
COVID Test - (Adaptive Biotechnologies Corporation)
Updated Emergency Use Authorizations
- Flowflex
COVID-19 Antigen Home Test (ACON Laboratories, Inc)
- Innovita
2019-nCoV Ab Test (Colloidal Gold) - (Innovita (Tangshan) Biological
Technology Co., Ltd.)
|
| July 22, 2022
Unique
Device Identification: Policy Regarding Compliance Dates for Class
I and Unclassified Devices, Direct Marking, and Global Unique Device
Identification Database Requirements for Certain Devices - Guidance
for Industry and Food and Drug Administration Staff
Co-sponsored
Public Workshop - Expediting Innovation of Bioelectronic Implants
for Vision Restoration, October 24-25, 2022
Federal
Register: Unique Device Identification: Policy Regarding Compliance
Dates for Class I and Unclassified Devices, Direct Marking, and
Global Unique Device Identification Database Requirements for Certain
Devices
|
|
July 21, 2022
New Emergency Use Authorizations
- Predicine
SARS-CoV-2 RT-PCR Test (Predicine, Inc.)
Reissued Emergency Use Authorizations
- HealthPulse@home
(Audere)
Revoked 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))
- 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))
Federal
Register: Emergency Use Authorization: Certain Medical Devices during
COVID-19
|
|
July 20, 2022
iHealth
Labs, Inc.: iHealth COVID-19 Antigen Rapid Test (Updated Expiration
Date)
Class
I Recall: Smiths Medical Recalls Certain Medfusion 3500 and 4000
Syringe Infusion Pumps for Software Issues That May Impact Infusion
Delivery
24
Hour Summary for July 12-13, 2022 Patient Engagement Advisory Committee
Meeting
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200035
added)
|
|
July 19, 2022
Supplies
of Medical Devices for COVID-19: Frequently Asked Questions (Updated)
Medical
Device Shortages During the COVID-19 Public Health Emergency (Updated)
Medical
Device Types to Help Determine Section 506J Notification Obligations
(Updated)
Medical
Gowns (Updated)
Pruebas
de COVID-19 sin receta médica o de venta libre para diagnóstico
en el hogar (Updated)
At-Home
OTC COVID-19 Diagnostic Tests (SD Biosensor updated)
|
|
July 18, 2022
Reissued Emergency Use Authorizations
- Helix
SARS-CoV-2 Test (Helix OpCo LLC (dba Helix))
Revised Emergency Use AUthorizations
- BD
SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson and Company
(BD))
Updated Emergency Use Authorizations
- Bio-Speedy
Direct RT-qPCR SARS-CoV-2 (Bioeksen R&D Technologies Inc.)
- VITROS
Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent
Pack used in combination with VITROS Immunodiagnostic Products Anti-SARS-CoV-2
IgG Quantitative Calibrator (Ortho-Clinical Diagnostics, Inc.)
Tracking
Your Premarket Submission’s Progress (Progress Tracker) (Updated)
|
| July 15, 2022
Monkeypox
Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety
Communication
CDRH
Petitions (Updated)
|
|
July 14, 2022
SARS-CoV-2
Viral Mutations: Impact on COVID-19 Tests (Updated)
Class
I Recall: American Contract Systems Recalls COVID Test Kits Nonsterile
and Clean Catch Urine Kits for Risk of False Results
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN210045
added)
|
|
July 13, 2022
Revised Emergency Use Authorizations
- iHealth
COVID-19 Antigen Rapid Test (iHealth Labs, Inc.)
|
|
July 12, 2022
New Emergency Use Authorization
- Speedy
Swab Rapid COVID-19 Antigen Self-Test (Watmind USA)
- Genabio
COVID-19 Rapid Self-Test Kit (Genabio Diagnostics Inc.)
|
|
July 11, 2022
Reissued Emergency Use Authorizations
- Rheonix
COVID-19 MDx Assay (Rheonix, Inc.)
Revised Emergency Use Authorizations
- Pixel
by Labcorp COVID-19 Test Home Collection Kit (Laboratory Corporation
of America (LabCorp))
- Quest
COVID-19 PCR Test Home Collection Kit (Quest Diagnostics Nichols
Institute)
Updated Emergency Use Authorizations
- SalivaDirect
At-Home Collection Kit (Yale School of Public Health, Department
of Epidemiology of Microbial Diseases)
- SalivaDirect
DTC Saliva Collection Kit (Yale School of Public Health, Department
of Epidemiology of Microbial Diseases)
- Procleix
SARS-CoV-2 Assay (Grifols Diagnostic Solutions, Inc.)
- Abbott
RealTime SARS-CoV-2 (Abbott Molecular Inc.)
|
|
July 8, 2022
Meeting
Materials for July 12-13, 2022 Patient Engagement Advisory Committee
Meeting
510(k)
Third Party Review Organization Performance Report FY22 - Q3
|
|
July 7, 2022
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- July 27 and August 24
Webcast
Links for July 28-29, 2022 General and Plastic Surgery Devices Panel
of the Medical Devices Advisory Committee Meeting
|
|
July 6, 2022
Class
I Recall: Getinge USA Sales Inc Recalls Flow-c and Flow-e Anesthesia
Systems for Cracked or Broken Suction System Power Switches
MedSun
Newsletter - July 2022
|
|
July 5, 2022
Updated Emergency Use Authorizations
- 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.)
At-Home
OTC COVID-19 Diagnostic Tests (InBios International and SD Biosensor
updated)
Pruebas
de COVID-19 sin receta médica o de venta libre para diagnóstico
en el hogar (InBios International and SD Biosensor actualizado)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN210004
added)
Federal
Register: Public Advisory Panels of the Medical Devices Advisory
Committee
|
| May 31, 2022
Consumer
Information on: AccelStim Bone Growth Stimulator – P210035
Federal
Register: Cardiovascular Devices; Classification of the Coronary
Artery Disease Risk Indicator Using Acoustic Heart Signals
|
| May 27, 2022
Meeting
Notice: July 28-29, 2022 General and Plastic Surgery Devices Panel
of the Medical Devices Advisory Committee
Class
I Recall: ArjoHuntleigh Polska Recalls Sara Plus Floor Lift for
Risk of Smoke or Fire When Lift Is Used with Depleted Battery
|
|
May 26, 2022
Class
I Recall: Abbott Medical Recalls Dragonfly OpStar Imaging Catheter
for Potential Loose Catheter Marker Band That May Cause Patient
Harm
Transcript
and Presentation added to Virtual Town Hall Series - Coronavirus
(COVID-19) Test Development and Validation - May 18, 2022
Federal
Register: General and Plastic Surgery Devices Panel of the Medical
Devices Advisory Committee
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Postmarket Surveillance of Medical Devices
|
|
May 25, 2022
New Emergency Use Authorizations
- AdvanSure
SARS-CoV-2 IgG(S1) ELISA (LG Chem, Ltd.)
Reissued Emergency Use Authorizations
- Celltrion
DiaTrust COVID-19 Ag Home Test (Celltrion USA, Inc.)
Updated Emergency Use Authorizations
- Atellica
IM SARS-CoV-2 Antigen (CoV2Ag) (Siemens Healthcare Diagnostics,
Inc.)
- ADVIA
Centaur SARS-CoV-2 Antigen (CoV2Ag) (Siemens Healthcare Diagnostics,
Inc.)
CDRH
Management Directory by Organization (Updated)
|
|
May 24, 2022
CDRH
Petitions (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200019,
and DEN200072 added)
List
of Cleared or Approved Companion Diagnostic Devices (In Vitro and
Imaging Tools) (Updated)
|
|
May 23, 2022
Consumer
Information on: Alinity m CMV Assay - P210022
Genetic
Non-Invasive Prenatal Screening Tests May Have False Results: FDA
Safety Communication
- Las
pruebas de detección genética prenatal no invasivas
pueden dar resultados falsos: Comunicado de seguridad de la FDA
(Spanish - New)
Federal
Register: Emergency Use Authorization: In Vitro Diagnostic Device
for Detection and/or Diagnosis of COVID-19; Revocation
|
| May 20, 2022
Consumer
Information on: Thoraflex Hybrid - P210006
Virtual
Public Workshop - Building Medical Device Supply Chain Resilience:
A Healthcare and Public Health Ecosystem-Wide Collaboration (Updated)
Medical
Devices and Radiation-Emitting Products Committee Vacancies (Updated)
Roster
of the Radiological Devices Panel (Updated)
Roster
of the General and Plastic Surgery Devices Panel (Updated)
STEM
Career Opportunities at CDRH (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
May 19, 2022
New Emergency Use Authorizations
- Labcorp
Seasonal Respiratory Virus RT-PCR Test (Laboratory Corporation of
America (Labcorp))
- Nexus
High Throughput SARS-CoV-2 Assay (Nexus Medical Labs, LLC)
Reissued Emergency Use Authorizations
- TaqPath
COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
- Accula
SARS-Cov-2 Test (Mesa Biotech Inc.)
- Celltrion
DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN210046
added)
Webinar
- Cybersecurity in Medical Devices: Quality System Considerations
and Content of Premarket Submissions - Draft Guidance - 06/14/2022
Ethylene
Oxide Sterilization for Medical Devices (Updated)
Federal
Register: 510(k) Sterility Change Master File Pilot Program
Update:
Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP
Machines Recalled Due to Potential Health Risks: FDA Safety Communication
(Updated)
FAQs
on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine
Recalls (Updated)
|
|
May 18, 2022
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN210044
added)
Transcript
added to Public Meeting - Medical Device User Fee Amendments for
Fiscal Years 2023 Through 2027 - April 19, 2022
Medical
Device Material Safety Summaries (Updated)
Catalog
of Regulatory Science Tools to Help Assess New Medical Devices (Updated)
Consumer
Information on: Organ Care System (OCS) Heart System – P180051/S001
|
|
May 17, 2022
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN180065,
DEN200038, and DEN210006 added)
|
|
May 16, 2022
New Emergency Use Authorizations
- Labcorp
Seasonal Respiratory Virus RT-PCR DTC Test (Laboratory Corporation
of America (Labcorp))
Avanos
Medical Recalls Cortrak*2 Enteral Access System for Risk of Misplaced
Enteral Tubes Could Cause Patient Harm (Updated)
Class
I Recall: Woodside Acquisitions Inc. Recalls Oral Rapid SARS-CoV-2
Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test
Kits (Colloidal Gold) That Are Not Authorized, Cleared, or Approved
by the FDA
|
| May 13, 2022
New Emergency Use Authorizations
- ID
NOW COVID-19 2.0 (Abbott Diagnostics Scarborough, Inc.)
- Xpert
Xpress CoV-2 plus (Cepheid)
Revised Emergency Use Authorizations
- INDICAID
COVID-19 Rapid Antigen At-Home Test (PHASE Scientific International,
Ltd.)
- INDICAID
COVID-19 Rapid Antigen Test (PHASE Scientific International, Ltd.)
- CareStart
COVID-19 Antigen Home Test (Access Bio, Inc.)
Updated Emergency Use Authorizations
- BinaxNOW
COVID-19 Ag Card Home Test (Abbott Diagnostics Scarborough, Inc.)
Revoked Emergency Use Authorizations
- Simoa
Semi-Quantitative SARS-CoV-2 IgG Antibody Test (Quanterix Corporation)
- Simoa
SARS-CoV-2 N Protein Antigen Test (Quanterix Corporation)
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
(Updated)
Updated
CDRH Learn Module: How is CDRH Structured?
Class
I Recall: Avanos Medical Recalls Cortrak*2 Enteral Access System
for Risk of Misplaced Enteral Tubes Could Cause Patient Harm
|
|
May 11, 2022
Consumer
Information on: CardioMEMS HF System - P100045/S056
Transcript
and Presentation added to Virtual Town Hall Series - Coronavirus
(COVID-19) Test Development and Validation - May 4, 2022
|
|
May 10, 2022
Do
Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA
Safety Communication
Class
I Recall: SML Distribution LLC Recalls Skippack Medical Lab COVID-19
Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or
Approved by the FDA
Review
Memos for Third Party 510(k) Reviewers
|
|
May 9, 2022
Class
I Recall: Mesa Biotech, Inc., Recalls Certain Accula SARS-CoV-2
Tests for Risk of False Positives Caused by Contamination
|
|
May 6, 2022
Reissued Emergency Use Authorizations
- TaqPath
COVID-19 RNase P Combo Kit 2.0 (Thermo Fisher Scientific Inc.)
Revised Emergency Use Authorizations
- Solana
SARS-CoV-2 Assay (Quidel Corporation)
- ASSURE-100
Rapid COVID-19 Test (Oceanit Foundry LLC)
- Cormeum
SARS-CoV-2 Assay (Cormeum Laboratory Services)
Revoked Emergency Use Authorizatioins
- CRSP
SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay
(Clinical Research Sequencing Platform (CRSP), LLC at theBroad Institute
of MIT and Harvard)
Updated Emergency Use Authorizations
- Biosearch
Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test (LGC,
Biosearch Technologies)
Potential
Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis
Machines Manufactured by Fresenius Medical Care – Letter to
Health Care Providers
|
|
May 5, 2022
Feasibility
and Early Feasibility Clinical Studies for Certain Medical Devices
Intended to Therapeutically Improve Glycemic Control in Patients
with Type 2 Diabetes Mellitus - Guidance for Industry and Food and
Drug Administration Staff
Virtual
Public Workshop - Animal Studies for Orthopedic Products - June
2, 2022
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200072
added)
Fostering
Medical Device Improvement: FDA Activities and Engagement with the
Voluntary Improvement Program - Draft Guidance for Industry and
Food and Drug Administration Staff
Voluntary
Medical Device Manufacturing and Product Quality Pilot Program (Updated)
Medtronic
HeartWare Ventricular Assist Device (HVAD) System
Federal
Register: Cardiovascular Devices; Classification of the Reverse
Central Venous Recanalization System
Federal
Register: Gastroenterology-Urology Devices; Classification of the
Magnetically Maneuvered Capsule Endoscopy System
Federal
Register: General and Plastic Surgery Devices; Classification of
the Mountable Electromechanical Surgical System for Transluminal
Approaches
Federal
Register: Investigational Device Exemptions
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: Fostering Medical Device Improvement: Food and Drug Administration
Activities and Engagement with the Voluntary Improvement Program
|
|
May 4, 2022
Supplements
for Approved Premarket Approval (PMA) or Humanitarian Device Exemption
(HDE) Submissions During the Coronavirus Disease 2019 (COVID-19)
Public Health Emergency (Revised) - Guidance for Industry and Food
and Drug Administration Staff
MedSun
Newsletter: May 2022, Volume 22, Issue 5
|
|
May 3, 2022
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200063
added)
MQSA
National Statistics (Updated)
|
|
May 2, 2022
New Emergency Use Authorizations
- Biosearch
Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test
(LGC, Biosearch Technologies)
- HealthPulse@home
Fusion (Audere)
Updated Emergency Use Authorizations
- Cue
COVID-19 Test for Home and Over The Counter (OTC) Use (Cue Health
Inc.)
- Flowflex
COVID-19 Antigen Home Test (ACON Laboratories, Inc.)
- OHC
COVID-19 Antigen Self Test (OSANG LLC)
- Detect
Covid-19 Test (Detect, Inc.)
- Real-Time
Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 (BGI Genomics Co.
Ltd)
- Xpert
Xpress SARS-CoV-2 test (Cepheid)
- SARS-CoV-2
(N gene detection) Test (Exact Sciences Laboratories)
- IntelliPlex
SARS-CoV-2 Detection Kit (PlexBio Co., Ltd.)
- TaqPath
COVID-19 RNase P Combo Kit 2.0 (Thermo Fisher Scientific Inc.)
Revised Emergency Use Authorizations
- Pilot
COVID-19 At-Home Test (SD Biosensor, Inc.)
- BioFire
Respiratory Panel 2.1-EZ (RP2.1-EZ (BioFire Diagnostics, LLC)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200066
added)
OHT8:
Office of Radiological Health (New)
Philips
Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked
Questions (Updated)
Medical
Device User Fee Amendments 2023 (MDUFA V)
- FDA-Industry
MDUFA V Reauthorization Meeting, March 15, 2022
Federal
Register: Administrative Detention and Banned Medical Devices
|
| April 29, 2022
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Consumer
Information on: Agili-C – P210034
Counterfeit
At-Home OTC COVID-19 Diagnostic Tests
|
|
April 28, 2022
Digital
Health Policies and Public Health Solutions for COVID-19 (Updated)
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
At-Home
COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated)
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - April 20, 2022
Potential
for Internal Pump Malfunction in the Medtronic HVAD System –
Letter to Health Care Providers
Celltrion
USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test
Kits Which May Have Been Distributed to Unauthorized, Non-CLIA-Certified
Users
|
|
April 27, 2022
Potential
Risk of Airway Obstruction When Using Certain Electromyogram Endotracheal
Tubes – Letter to Health Care Providers
|
|
April 26, 2022
Class
I Recall: Medtronic Recalls Harmony Delivery Catheter, Part of Transcatheter
Pulmonary Valve (TPV) System, for Risk of Capsule Break During Use
Medical
Device User Fee Amendments 2023 (MDUFA V) (Updated - Industry Discussions
on MDUFA V Reauthorization)
- FDA-Industry
MDUFA V Reauthorization Meeting, March 7, 2022
- FDA-Industry
MDUFA V Reauthorization Meeting, March 3, 2022
- FDA-Industry
MDUFA V Reauthorization Meeting, March 2, 2022
- FDA-Industry
MDUFA V Reauthorization Meeting, February 24, 2022
- FDA-Industry
MDUFA V Reauthorization Meeting, February 22, 2022
Medical
Device Development Tools (MDDT) (Updated)
- New tool: FACE-Q Aesthetics
Transcripts
added to Virtual Public Workshop - 3D Printing in Hospitals: Veteran’s
Health Administration’s Experiences in Point of Care 3D Printing
of Device and Implementing a Quality Management System - March 16
-17, 2022
|
|
April 25, 2022
New Emergency Use Authorizations
- OPTI
SARS-CoV-2/ Influenza A/B RT-PCR Test (Version 1 and Version 2)
(OPTI Medical Systems, Inc.)
Revoked Emergency Use Authorizations
- Linea
COVID-19 Assay Kit (Applied DNA Sciences, Inc.)
Re-issued Emergency Use Authorizations
- PMLS
SARS-CoV-2 Assay (Premier Medical Laboratory Services)
Revised Emergency Use Authorizations
- Flowflex
COVID-19 Antigen Home Test (ACON Laboratories, Inc.)
- SARS-CoV-2
RBD IgG test (Emory Medical Laboratories)
Updated Emergency Use Authorizations
- Ellume
COVID-19 Home Test (Ellume Limited)
- InteliSwab
COVID-19 Rapid Test (OraSure Technologies, Inc.)
- QuickVue
At-Home OTC COVID-19 Test (Quidel Corporation)
- INDICAID
COVID-19 Rapid Antigen At-Home Test (PHASE Scientific International,
Ltd.)
- AdviseDx
SARS-CoV-2 IgG II (Abbott Laboratories Inc.)
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- May 4, May 18, June 1, June 15, and June 29
Medical
Device User Fee Amendments 2023 (MDUFA V) (Updated - Industry Discussions
on MDUFA V Reauthorization)
- FDA-Industry
MDUFA V Reauthorization Meeting, February 15, 2022
- FDA-Industry
MDUFA V Reauthorization Meeting, February 10, 2022
- FDA-Industry
MDUFA V Reauthorization Meeting, February 8, 2022
- FDA-Industry
MDUFA V Reauthorization Meeting, February 3, 2022
- FDA-Industry
MDUFA V Reauthorization Meeting, November 18, 2021
- FDA-Industry
MDUFA V Reauthorization Meeting, November 9, 2021
- FDA-Industry
MDUFA V Reauthorization Meeting, October 20, 2021
- FDA-Industry
MDUFA V Reauthorization Meeting, October 7, 2021
- FDA-Industry
MDUFA V Reauthorization Meeting, September 22, 2021
|
| April 22,2022
FAQs
on Viral Transport Media During COVID-19 (Updated)
STEM
Career Opportunities at CDRH (Updated)
|
|
April 21,2022
Consumer
Information on: Aveir Leadless Pacing System – Aveir Leadless
Pacemaker, Model LSP112V (Right Ventricular); Aveir Delivery Catheter,
Model LSCD111; and Aveir Link Module, Module LSL02 – P150035
Refuse
to Accept Policy for 510(k)s: Guidance for Industry and Food and
Drug Administration Staff (Updated)
Federal
Register: Food and Drug Administration Modernization Act: Modifications
to the List of Recognized Standards, Recognition List Number: 057
Federal
Register: Guidance: Compliance Policy Guides; Withdrawal
|
|
April 20, 2022
Ventilators
and Ventilator Accessories EUAs - Appendix B: Authorized Ventilators
(Updated)
Ventilators
and Ventilator Accessories EUAs - Appendix B: Authorized Ventilator
Accessories (Updated)
Virtual
Public Workshop - Building Medical Device Supply Chain Resilience:
A Healthcare and Public Health Ecosystem-Wide Collaboration - June
7-9, 2022
Resilient
Supply Chain Program for Medical Devices
Transcript
for October 6, 2021 Patient Engagement Advisory Committee Meeting
|
|
April 19, 2022
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - April 6, 2022
Genetic
Non-Invasive Prenatal Screening Tests May Have False Results: FDA
Safety Communication
|
|
April 18, 2022
New Emergency Use Authorizations
-
MicroGEM Sal6830 SARS-CoV-2 Saliva Test (MicroGEM U.S., Inc.)
Revoked Emergency Use Authorizations
- Bio-Rad
Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit (Bio-Rad Laboratories,
Inc.)
Updated Emergency Use Authorizations
- EURORealTime
SARS-Cov-2 (Euroimmun US, Inc.)
- Ellume
COVID-19 Home Test (Ellume Limited)
- InteliSwab
COVID-19 Rapid Test (OraSure Technologies, Inc.)
Consumer
Information on: EVO/EVO+ VISIAN Implantable Collamer Lens –
P030016/S035
Consumer
Information on: Et Control - P210018
Public
Meeting - Medical Device User Fee Amendments for Fiscal Years 2023
Through 2027 - 04/19/2022 (Updated Agenda)
|
| April 15, 2022
Breakthrough
Devices Program
|
|
April 14, 2022
New Emergency Use Authorizations
- InspectIR
COVID-19 Breathalyzer (InspectIR Systems LLC)
In
Vitro Diagnostics EUAs - Other Diagnostic Tests for SARS-CoV-2
|
|
April 13, 2022
New Emergency Use Authorizations
- Cleveland
Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute,
SelfCheck cobas SARS-CoV-2 + Flu Assa
Re-issued Emergency Use Authorizations
- For
Detect, Inc., Detect Covid-19 Test
Updated Emergency Use Authorizations
- Biomeme,
Inc., Biomeme SARS-CoV-2 Real-Time RT-PCR Test
- Abbott
Diagnostics Scarborough, Inc., BinaxNOW COVID-19 Ag Card Home Test
- iHealth
Labs, Inc., iHealth COVID-19 Antigen Rapid Test
- InBios
International Inc., SCoV-2 Ag Detect Rapid Self-Test
CDRH
Patient Engagement Advisory Committee (Updated)
July
12-13, 2022: Patient Engagement Advisory Committee Meeting Announcement
Federal
Register: Meetings: Patient Engagement Advisory Committee
Federal
Register: Performance Criteria for Safety and Performance Based
Pathway
|
|
April 12, 2022
Denture
Base Resins - Performance Criteria for Safety and Performance Based
Pathway - Guidance for Industry and Food and Drug Administration
Staff
Facet
Screw Systems - Performance Criteria for Safety and Performance
Based Pathway - Guidance for Industry and Food and Drug Administration
Staff
|
|
April 11, 2022
New Emergency Use Authorizations
- UCSD
BCG EXCITE , COVID-19 EL Test
- DC
Department of Health, Test Yourself DC At-Home COVID-19 Collection
Kit
Revised Emergency Use Authorizations
- Biomeme,
Inc., SARS-CoV-2 Real-Time RT-PCR Test
- Laboratory
Corporation of America (Labcorp), COVID-19 RT-PCR Test
Updated Emergency Use Authorizations
- Avellino
Lab USA, Inc., Biomeme SARS-CoV-2 Real-Time RT-PCR Test
- Abbott
Laboratories Inc., AdviseDx SARS-CoV-2 IgG II
Intended
Use of Imaging Software for Intracranial Large Vessel Occlusion
- Letter to Health Care Providers
|
| April 8, 2022
Surgical
Sutures - Performance Criteria for Safety and Performance Based
Pathway - Guidance for Industry and Food and Drug Administration
Staff
Orthopedic
Fracture Fixation Plates - Performance Criteria for Safety and Performance
Based Pathway - Guidance for Industry and Food and Drug Administration
Staff
510(k)
Third Party Performance Metrics and Accreditation Status (Added
Performance Report for FY22, Q2)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
April 7, 2022
New Emergency Use Authorizations
- OSANG
LLC, OHC COVID-19 Antigen Self Test
- Xiamen
Boson Biotech Co., Ltd., Rapid SARS-CoV-2 Antigen Test Card
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
Cybersecurity
in Medical Devices: Quality System Considerations and Content of
Premarket Submissions - Draft Guidance for Industry and Food and
Drug Administration Staff
Federal
Register: Cybersecurity in Medical Devices: Quality System Considerations
and Content of Premarket Submissions
|
|
April 6, 2022
Public
Meeting - Medical Device User Fee Amendments for Fiscal Years 2023
Through 2027
Federal
Register: Medical Devices; Humanitarian Use Devices
Federal
Register: Medical Device User Fee Amendments
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
April 5, 2022
Reissued Emergency Use Authorizations
- BinaxNOW
COVID-19 Antigen Self Test (Abbott Diagnostics Scarborough, Inc.)
- Pilot
COVID-19 At-Home Test (SD Biosensor, Inc.)
Revised Emergency Use Authorizations
- Pixel
by LabCorp COVID-19 Test Home Collection Kit (Laboratory Corporation
of America (LabCorp))
- Quest
COVID-19 PCR Test Home Collection Kit (Quest Diagnostics Nichols
Institute)
- iHealth
COVID-19 Antigen Rapid Test (iHealth Labs, Inc.)
Medical
Device Interoperability (Updated)
Use
Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety
Communication
Infections
Associated with Reprocessed Duodenoscopes (Updated)
Working
Together to Improve Reusable Medical Device Reprocessing (Updated)
MedSun
Newsletter: April 2022, Volume 22, Issue 4
Roster
of the National Mammography Quality Assurance Advisory Committee
(Updated)
|
|
April 4, 2022
UPDATE:
Change in Reprocessing Methods with Certain Karl Storz Urological
Endoscopes – Letter to Health Care Providers
ASCA-Accredited
Testing Laboratories (Updated)
|
| April 1, 2022
MQSA
National Statistics (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Scientific
Fellowships at CDRH (Updated)
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - March 23, 2022
CDRH
Management Directory by Organization (Updated)
|
| March 31, 2022
Revised Emergency Use Authorizations
- Alinity
m Resp-4-Plex (Abbott Molecular Inc.)
- iHealth
COVID-19 Antigen Rapid Test (iHealth Labs, Inc.)
- MaximBio
ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.
Updated Emergency Use Authorizations
- Rapid
COVID-19 IgM/IgG Combo Test Kit (Megna Health, Inc.)
- Lucira
CHECK-IT COVID-19 Test Kit (Lucira Health, Inc.)
Magellan
Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra
Blood Lead Tests Due to Risk of Falsely Low Results (Updated)
List
of Cleared or Approved Companion Diagnostic Devices (In Vitro and
Imaging Tools) (Updated)
Consumer
Information on: Evoke Spinal Cord Stimulation (SCS) System –
P190002
|
|
March 30, 2022
At-Home OTC COVID-19 Diagnostic Tests
- Pruebas
de COVID-19 sin receta médica o de venta libre para diagnóstico
en el hogar (Spanish)
|
|
March 29, 2022
COVID-19
Test Development and Review: FAQs on Testing for SARS-CoV-2 (Updated)
Device
Evaluation Intern Program (CDRH) (Updated)
|
|
March 28, 2022
Reissued Emergency Use Authorizations
- Clear
Dx SARS-CoV-2 Test (Clear Labs, Inc.)
- Labcorp
SARS-CoV-2 & Influenza A/B Assay (Laboratory Corporation of
America (Labcorp))
Revised Emergency Use Authorizations
- Molecular
Diagnostic Tests for SARS-CoV-2 (Uh-Oh Labs Inc.)
- Novel
Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence
Probing) (Sansure BioTech Inc.)
Updated Emergency Use Authorizations
- cobas
SARS-CoV-2 & Influenza A/B Nucleic Acid Test (Roche Molecular
Systems, Inc.)
- CareStart
COVID-19 Antigen Home Test (For Access Bio, Inc.)
- BD
Veritor At-Home COVID-19 Test (Becton, Dickinson and Company (BD))
Consumer
Information on: Prometra Programmable Infusion Pump System - P080012/S068
Requesting
Speakers from CDRH (Updated)
Federal
Register: Technical Amendments
|
| March 25, 2022
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
March 24, 2022
Reissued Emergency Use Authorizations
- Aptima
SARS-CoV-2 assay (Hologic, Inc.)
- Aptima
SARS-CoV-2/Flu assay (Hologic, Inc.)
- Panther
Fusion SARS-CoV-2 Assay (Hologic, Inc.)
Updated Emergency Use Authorizations
- Helix
SARS-CoV-2 Test (Helix OpCo LLC (dba Helix))
- Quest
COVID-19 PCR DTC (Quest Diagnostics Nichols Institute)
- Celltrion
DiaTrust COVID-19 Ag Home Test (Celltrion USA, Inc.)
- CLINITEST
Rapid COVID-19 Antigen Self-Test (Siemens Healthineers)
- MaximBio
ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.)
|
|
March 23, 2022
Automated
External Defibrillators (AEDs) (Updated)
Class
I Recall: Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19
Ag Rapid Test Kits Labeled for Research Use Only
|
|
March 22, 2022
New Emergency Use Authorizations
- Quest
COVID-19 PCR Test Home Collection Kit (Quest Diagnostics Nichols
Institute)
- Quest
RC COVID-19 PCR DTC (Quest Diagnostics Nichols Institute)
- Quest
PF COVID-19 PCR DTC (Quest Diagnostics Nichols Institute)
- Quest
COVID-19 PCR DTC (Quest Diagnostics Nichols Institute)
Reissued Emergency Use Authorization
- iC
SARS-CoV2 Test (Tempus Labs, Inc.)
Updated Emergency Use Authorization
- Ellume
COVID-19 Home Test (Ellume Limited)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
March 21, 2022
Class
I Recall: Philips Respironics Recalls Certain V60 and V60 Plus Ventilators
for Expired Adhesive that May Cause Ventilator to Stop Working With
or Without an Alarm
Prefilled
Saline Flush Syringe Conservation Strategies - Letter to Health
Care Personnel
Medical
Device Shortages During the COVID-19 Public Health Emergency (Updated)
|
| March 18, 2022
New Emergency Use Authorizations
- Helix
SARS-CoV-2 Test (Helix OpCo LLC (dba Helix))
Revoked Emergency Use Authorizations
- qSanger-COVID-19
Assay (BillionToOne, Inc.)
- Diagnovital
SARS-CoV-2 Real-Time PCR Kit (RTA Laboratories Biological Products
Pharmaceutical and Machinery Industry)
- CentoFast-SARS-CoV-2
RT-PCR Assay (CENTOGENE US, LLC)
- CentoSure
SARS-CoV-2 RT-PCR Assay (CENTOGENE US, LLC)
- DiaSorin
LIAISON SARS-CoV-2 IgM Assay (DiaSorin Inc.)
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
Use
and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm:
FDA Safety Communication
At-Home
COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - March 9, 2022
Consumer
Information on: eCoin Peripheral Neurostimulator – P200036
Consumer
Information on: FoundationOne CDx – P170019/S029
|
|
March 17, 2022
New Emergency Use Authorizations
- Atellica
IM SARS-CoV-2 Antigen (CoV2Ag) (Siemens Healthcare Diagnostics,
Inc.)
- ADVIA
Centaur SARS-CoV-2 Antigen (CoV2Ag) (Siemens Healthcare Diagnostics,
Inc.)
- DASH
SARS-CoV-2/S Test (Minute Molecular Diagnostics, Inc.)
Reissued Emergency Use Authorizations
- Ellume
COVID-19 Home Test (Ellume Limited)
Revised Emergency Use Authorizations
- TaqPath
COVID-19, FluA, FluB Combo Kit (Thermo Fisher Scientific)
- Bio-Rad
SARS-CoV-2 ddPCR Test (Bio-Rad Laboratories, Inc.)
Updated Emergency Use Authorizations
- MaximBio
ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.)
List
of Cleared or Approved Companion Diagnostic Devices (In Vitro and
Imaging Tools) (FoundationOne CDx updated)
Celltrion
USA Recalls Certain Celltrion DiaTrust COVID-19 Ag Rapid Tests for
False Positive Test Results and Unauthorized Shelf Life (Updated)
Fact
Sheet: Mitigating and Preventing Medical Device Shortages and Prioritizing
Public Health
|
|
March 16, 2022
New Emergency Use Authorization
-
INDICAID COVID-19 Rapid Antigen At-Home Test (PHASE Scientific International,
Ltd.)
Stop
Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication
(Updated)
Class
I Recall: SD Biosensor Recalls STANDARD Q COVID-19 Ag Home Tests
That Are Not Authorized, Cleared, or Approved by the FDA and May
Give False Results
CDRH
Learn Module Updates:
- Presentation and Transcript added for COVID-19 Transition Policy
for Devices, Draft Guidances
- Presentation and Transcript added for Patient-Reported Outcome
Instruments for Use in Medical Device Evaluation, Final Guidance
24
Hour Summary and Presentations for March 2, 2022 Device Good Manufacturing
Practice Advisory Committee Meeting
|
|
March 15, 2022
Reissued Emergency Use Authorizations
- RapidRona,
Inc. – RapidRona Self-Collection Kit
Revised Emergency Use Authorizations
- Premier
Medical Laboratory Services – PMLS SARS-CoV-2 Assay
- BioFire
Defense, LLC – BioFire COVID-19 Test
- Thermo
Fisher Scientific Inc. – Amplitude Solution with the TaqPath
COVID-19 High-Throughput Combo Kit
Updated Emergency Use Authorizations
- For
Uh-Oh Labs Inc. – UOL COVID-19 Test
Presentation
and Transcript added to: Webinar on Draft Guidances on Transition
Plans for COVID-19 Related Medical Devices - February 22, 2022
February
2022 PMA Approval List
Children
and Teens and Cell Phones (Updated)
Scientific
Research Jobs, Fellowships, and Collaborations on Medical Devices
(Updated)
Science
and Research | Medical Devices (Updated)
Class
I Recall: Celltrion USA Recalls Celltrion DiaTrust COVID-19 Ag Rapid
Tests for False Positive Test Results and Unauthorized Shelf Life
Federal
Register: Medical Device Accessories
|
|
March 14, 2022
Reissued Emergency Use Authorizations
- Clip
COVID Rapid Antigen Test (Luminostics, Inc.)
Revised Emergency Use Authorizations
- Rapid
COVID-19 IgM/IgG Combo Test Kit (Megna Health, Inc.)
- SCoV-2
Ag Detect Rapid Self-Test (InBios International Inc.)
- SCoV-2
Ag Detect Rapid Test (InBios International Inc.)
- COVID-19
At-Home Test (SD Biosensor, Inc.)
Updated Emergency Use Authorizations
-
xMAP SARS-CoV-2 Multi-Antigen IgG Assay (Luminex Corporation)
- Dimension
Vista SARS CoV 2 IgG (COV2G) (Siemens Healthcare Diagnostics Inc.)
- Dimension
EXL SARS CoV 2 IgG (CV2G) (Siemens Healthcare Diagnostics Inc.)
- CLINITEST
Rapid COVID-19 Antigen Self-Test (Siemens Healthineers)
- MaximBio
ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.)
Essure
Permanent Birth Control (Updated)
- Essure
Benefits and Risk (Updated)
- Information
for Patients and Health Care Providers: Essure (Updated)
- FDA
Activities Related to Essure (Updated)
- Problems
Reported with Essure (Updated)
Philips
Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked
Questions (Updated)
Update:
Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines
Recalled Due to Potential Health Risks: FDA Safety Communication
(Updated)
FDA
Warns Against Use of Renuvion/J-Plasma Device for Certain Aesthetic
Procedures: FDA Safety Communication
LuSys
Laboratories, Inc Recalls COVID-19 Antigen Tests (Nasal/Saliva)
and COVID-19 IgG/IgM Antibody Tests Because They Are Not Authorized,
Cleared, or Approved by the FDA
Federal
Register: Agreement for Shipment of Devices for Sterilization
|
| March 11, 2022
Voluntary
eSTAR Program (Updated)
Do
Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication
(Updated)
Class
I Recall: Baxter recalls SIGMA Spectrum Infusion Pumps with Master
Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose
IQ Safety Software (Version 9) due to the risk of not alarming for
repeated upstream occlusion events
|
|
March 10, 2022
Philips
Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked
Questions (Updated)
Update:
Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines
Recalled Due to Potential Health Risks: FDA Safety Communication
(Updated)
|
|
March 9, 2022
Class
I Recall: Medtronic Recalls TurboHawk Plus Directional Atherectomy
System Due to Risk of Tip Damage During Use
Umbrella
EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing
(Updated)
Job
Opportunities at OSEL (Updated)
|
|
March 8, 2022
Cybersecurity
Alert: Vulnerabilities identified in medical device software components:
PTC Axeda agent and Axeda Desktop Server
|
|
March 7, 2022
New Emergency Use Authorizations
- Surgical
Mask, Model Numbers 2110 and 2120 (Supermax Healthcare Canada -
Supermax Medical)
MedSun
Newsletter: March 2022, Volume 22, Issue 3
|
|
March 3, 2022
New Emergency Use Authorizations
- ASSURE-100
Rapid COVID-19 Test (Oceanit Foundry LLC)
Revised Emergency Use Authorizations
- TaqPath
COVID-19 RNase P Combo Kit (Thermo Fisher Scientific Inc.)
- Platelia
SARS-CoV-2 Total Ab assay (Bio-Rad Laboratories, Inc.)
- QIAreach
Anti-SARS-CoV-2 Total Test (QIAGEN, GmbH)
- EUROIMMUN
Anti-SARS-CoV-2 S1 Curve ELISA (IgG) (EUROIMMUN US, Inc.)
Reissued Emergency Use Authorizations
- SalivaDirect
At-Home Collection Kit (Yale School of Public Health, Department
of Epidemiology of Microbial Diseases)
Updated Emergency Use Authorizations
- Cue
COVID-19 Test (Cue Health Inc.)
- Orawell
IgM/IgG Rapid Test (Jiangsu Well Biotech Co., Ltd.)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Federal
Register: In Vitro Diagnostic Devices for Detection and/or Diagnosis
of COVID-19; Revocation
|
|
March 2, 2022
Virtual
Public Workshop - 3D Printing in Hospitals: Veteran’s Health
Administration’s Experiences in Point of Care 3D Printing of
Device and Implementing a Quality Management System - 03/16/2022
(Updated Agenda)
Scientific
Fellowships at CDRH (Updated)
Consumer
Information on: Eversense E3 Continuous Glucose Monitoring System
- P160048/S016
Do
Not Use Certain Celltrion DiaTrust COVID-19 Tests: FDA Safety Communication
(Updated)
|
|
March 1, 2022
Appeal
Options Available to Mammography Facilities Concerning Adverse Accreditation
Decisions, Suspension/Revocation of Certificates, or Patient and
Physician Notification Orders - Guidance for Mammography Facilities
and Food and Drug Administration Staff
Center
for Devices and Radiological Health (CDRH) Appeals Processes - Guidance
for Industry and Food and Drug Administration Staff
Do
Not Use Certain Celltrion DiaTrust COVID-19 Tests: FDA Safety Communication
Do
Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests: FDA Safety
Communication
Do
Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication
MQSA
National Statistics (Updated)
Federal
Register: Appeal Options Available to Mammography Facilities Concerning
Adverse Accreditation Decisions, Suspension/Revocation of Certificates,
etc.
|
| February 28, 2022
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN170070
added)
Meeting
materials posted: March 2, 2022 Device Good Manufacturing Practice
Advisory Committee
FDA
Advisory Panel Recommendations on Lifelong Surveillance and Long-Term
Postmarket Data Collection for Patients with AAA Endovascular Aortic
Repair – Letter to Health Care Providers
Federal
Register: Orthopedic Devices; Classification of the Screw Sleeve
Bone Fixation Device
|
| February 25, 2022
Revised Emergency Use Authorizations
- INDICAID
COVID-19 Rapid Antigen Test (PHASE Scientific International, Ltd.)
Revoked Emergency Use Authorizations
- BinaxNOW
COVID-19 Ag Card 2 Home Test (Abbott Diagnostics Scarborough, Inc.)
Reissued Emergency Use Authorizations
- Assurance
SARS-CoV-2 Panel (Assurance Scientific Laboratories)
- Assurance
SARS-CoV-2 Panel DTC (Assurance Scientific Laboratories)
- SalivaDirect
for use with DTC Kits (Yale School of Public Health, Department
of Epidemiology of Microbial Diseases)
- SalivaDirect
DTC Saliva Collection Kit (Yale School of Public Health, Department
of Epidemiology of Microbial Diseases)
1st
Q FY 2022 MDUFA IV Performance Report
|
|
February 24, 2022
Antibody
(Serology) Testing for COVID-19: Information for Patients and Consumers
(Updated)
COVID-19
Test Development and Review: FAQs on Testing for SARS-CoV-2 (Updated)
COVID-19
Test Uses: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
February 23, 2022
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - February 9, 2022
Class
I and Class II Device Exemptions
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN210034
added)
Arrow
International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola
Percutaneous Thrombolytic Device Due to Risk of Tip Damage During
Use
|
|
February 22, 2022
Reissued Emergency Use Authorizations
- LumiraDx
SARS-CoV-2 RNA STAR Complete (LumiraDx UK Ltd.)
- Sherlock
CRISPR SARS-CoV-2 Kit (Sherlock BioSciences, Inc.)
- Flowflex
COVID-19 Antigen Home Test (ACON Laboratories, Inc.)
Updated Emergency Use Authorizations
- BD
SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson and Company
(BD))
Revised Emergency Use Authorizations
- LIAISON
SARS-CoV-2 Ag (DiaSorin, Inc.)
- LumiraDx
SARS-CoV-2 Ag Test (LumiraDx UK Ltd.)
Scientific
Fellowships at CDRH (Updated)
Quality
System (QS) Regulation/Medical Device Good Manufacturing Practices
(Updated)
Proposed
Rule: Quality System Regulation Amendments – Frequently Asked
Questions
At-Home
OTC COVID-19 Diagnostic Tests
Federal
Register: Proposed Rule: Medical Devices: Quality System Regulation
|
| February 18, 2022
E25Bio
Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized,
Cleared, or Approved by the FDA and May Give False Results
BASE10
Genetics Recalls RNAstill MTM Specimen Collection Kits That Are
Not Authorized, Cleared, or Approved by the FDA, May Give False
Results, and Require Special Training for Safe Handling
Do
Not Use E25Bio COVID-19 Tests: FDA Safety Communication (Updated)
About
Manufacturer and User Facility Device Experience (MAUDE) (Updated)
MDR
Data Files (Updated)
Medical
Device Reporting (MDR): How to Report Medical Device Problems (Updated)
Jobs
at the Center for Devices and Radiological Health (CDRH) (Updated)
- Scientific
Fellowships at CDRH
- STEM
Career Opportunities at CDRH
|
|
February 17, 2022
Meeting
Announcement: March 2, 2022 Device Good Manufacturing Practice Advisory
Committee
Class
I Recall: Vyaire Medical Recalls bellavista 1000 and 1000e Series
Ventilators Due to Issues with Software Configurations
Virtual
Public Workshop - 3D Printing in Hospitals: Veteran’s Health
Administration’s Experiences in Point of Care 3D Printing of
Device and Implementing a Quality Management System - March 16-17,
2022
Federal
Register: Cardiovascular Devices; Classification of the Percutaneous
Catheter for Creation of an Arteriovenous Fistula for Hemodialysis
Access
Federal
Register: Clinical Chemistry and Clinical Toxicology Devices; Classification
of the Integrated Continuous Glucose Monitoring System
Federal
Register: Ophthalmic Devices; Classification of the Electromechanical
Tear Stimulator
Federal
Register: Center for Devices and Radiological Health Appeals Processes
|
|
February 16, 2022
Reissued Emergency Use Authorizations
- BD
SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson and Company
(BD))
- HDPCR
SARS-CoV-2 Assay (ChromaCode Inc.)
Updated Emergency Use Authorizations
- LYHER
Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal
Gold) (Hangzhou Laihe Biotech Co., Ltd.)
- cobas
SARS-CoV-2 (Roche Molecular Systems, Inc.)
- cobas
SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.)
- COVID-Flu
Multiplex Assay (Exact Sciences Laboratories)
Revised Emergency Use Authorizations
- Quick
SARS-CoV-2rRT-PCR Kit (Zymo Research Corporation)
Revoked Emergency Use Authorization
- Omni
COVID-19 Assay by RT-PCR (Omnipathology Solutions Medical Corporation)
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- February 23, 2022
Federal
Register: Device Good Manufacturing Practice Advisory Committee
|
|
February 15, 2022
Consumer
Information on: Senza Spinal Cord Stimulation (SCS) System –
P130022/S042
Federal
Register: Technical Electronic Product Radiation Safety Standards
Committee
|
|
February 14, 2022
Updated Emergency Use Authorizations
- 1copy
COVID-19 qPCR Multi Kit (1drop Inc.)
Tracking
Your Premarket Submission's Progress (Progress Tracker) (Updated)
FDA
Activities Related to Essure (Updated)
Information
for Patients and Health Care Providers: Essure (Updated)
|
| February 11, 2022
FAQs
on Viral Transport Media During COVID-19 (Updated)
ASCA-Accredited
Testing Laboratories (Updated)
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - January 26, 2022
Federal
Register: Cardiovascular Devices; Classification of the Adjunctive
Predictive Cardiovascular Indicator
Federal
Register: General Hospital and Personal Use Devices; Classification
of the Spore Test Strip
|
|
February 10, 2022
New Emergency Use Authorizations
- Advanta
Dx COVID-19 EASE Assay (Fluidigm Corporation)
- UOL
COVID-19 Test (Uh-Oh Labs Inc.)
Reissued Emergency Use Authorizations
- CLINITEST
Rapid COVID-19 Antigen Self-Test (Siemens Healthineers)
Updated Emergency Use Authorizations
- Elecsys
Anti-SARS-CoV-2 S (Roche Diagnostics, Inc.)
- Anti-SARS-CoV-2
ELISA (IgG) (EUROIMMUN US Inc.)
- Cue
COVID-19 Test for Home and Over The Counter (OTC) Use (Cue Health
Inc.)
- Appendix
A: Authorized Molecular-Based Laboratory Developed Tests for Detection
of Nucleic Acid from SARS-CoV-2 - Removal of SARS-CoV-2 Test (Biocerna)
Revised Emergency Use Authorizations
- Alinity
m Resp-4-Plex (Abbott Molecular Inc.)
Revoked Emergency Use Authorization
- LifeHope
2019-nCoV Real-Time RT-PCR Diagnostic Panel (LifeHope Labs)
|
|
February 8, 2022
January
2022 PMA Approval List
Potential
Risk of Strangulation in Children Who Use Enteral Feeding Delivery
Sets - FDA Safety Communication
|
|
February 7, 2022
New Emergecy Use Authorization
- ViroKey
SARS-CoV-2 RT-PCR Test v2.0 (ViroKey SARS-CoV-2 RT-PCR Test v2.0)
Reissued Emergency Use Authorizations
- BinaxNOW
COVID-19 Ag Card Home Test (Abbott Diagnostics Scarborough, Inc.)
- BinaxNOW
COVID-19 Ag 2 Card (Abbott Diagnostics Scarborough, Inc.)
- ADEXUSDx
COVID-19 Test (NOWDiagnostics, Inc.)
- LetsGetChecked
Coronavirus (COVID-19) (LetsGetChecked, Inc.)
- PMLS
SARS-CoV-2 Assay (Premier Medical Laboratory Services)
Revised Emergency Use Authorizations
- BinaxNOW
COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.)
- Nano-Check
COVID-19 Antigen Test (Nano-Ditech Corp.)
- Assure
COVID-19 IgG/IgM Rapid Test Device (Assure Tech. (Hangzhou Co.,
Ltd))
- cPass
SARS-CoV-2 Neutralization Antibody Detection Kit (GenScript USA
Inc.)
- PerkinElmer
New Coronavirus Nucleic Acid Detection Kit (PerkinElmer, Inc.)
- Advanta
Dx SARS-CoV-2 RT-PCR Assay (Fluidigm Corporation)
- Color
COVID-19 Self-Swab Collection Kit with Saline (Color Health, 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)
- GWU
SARS-CoV-2 RT-PCR Test (George Washington University Public Health
Laboratory)
Federal
Register: Establishment Registration and Device Listing for Manufacturers
and Importers of Devices
|
|
February 4, 2022
Consumer
Information on: Nucleus 24 Cochlear Implant System - P970051/S205
Do
Not Use E25Bio COVID-19 Tests: FDA Safety Communication
MedSun
Newsletter, February 2022
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200080
Decision Summary Added)
Federal
Register: Notifying the Food and Drug Administration of a Permanent
Discontinuance or Interruption in Manufacturing of a Device Under
Section 506J of the Federal Food, Drug, and Cosmetic Act
|
|
February 3, 2022
CDRH
Strategic Priorities and Updates (Updated)
- 2022-2025
Strategic Priorities
Federal
Register: Cardiovascular Devices; Classification of the Photoplethysmograph
Analysis Software for Over-the-Counter Use
Federal
Register: General and Plastic Surgery Devices; Classification of
the Carbon Dioxide Gas Controlled Tissue Expander
Federal
Register: General Hospital and Personal Use Devices; Classification
of the Alternate Controller Enabled Infusion Pump
Federal
Register: Immunology and Microbiology Devices; Classification of
the System for Detection of Microorganisms and Antimicrobial Resistance
Using Reporter Expression
|
|
February 2, 2022
MQSA
Inspection Billing Invoice Process
eMDR
System Status (Updated)
|
|
February 1, 2022
MQSA
National Statistics
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- February 9, 2022
|
| January 31, 2022
Reissued Emergency Use Authorizations
- SalivaDirect
(Yale School of Public Health, Department of Epidemiology of Microbial
Diseases)
- 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 (STS Lab Holdco (a
subsidiary of Amazon.com Services LLC))
- COVID-19
IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) (Healgen
Scientific 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.)
- SCoV-2
Ag Detect Rapid Self-Test (InBios International Inc.)
Revised Emergency Use Authorization
- Amazon
Multi-Target SARS-CoV-2 Real-Time RT-PCR Test (STS Lab Holdco (a
subsidiary of Amazon.com Services LLC))
- Amazon
Real-Time RT-PCR Test for Detecting SARS-CoV-2 (STS Lab Holdco (a
subsidiary of Amazon.com Services LLC))
- Color
COVID-19 Self-Swab Collection Kit (Color Health, Inc.)
- Color
COVID-19 Self-Swab Collection Kit DTC (Color Health, Inc.)
- Psoma
COVID-19 RT Test (Psomagen, Inc.)
Updated Emergency Use Authorizations
- SARS-CoV-2
MassArray Test (National Jewish Health)
CDRH
2021 Annual Report
|
| January 28, 2022
Stop
Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication
Class
I Recall: Empowered Diagnostics Recalls COVID-19 Tests due to Risk
of False Results
|
|
January 27, 2022
Assessing
the Credibility of Computational Modeling and Simulation in Medical
Device Submissions - Draft Guidance for Industry and Food and Drug
Administration Staff (Comment period extended)
Credibility
of Computational Models Program: Research on Computational Models
and Simulation Associated with Medical Devices (Updated)
Federal
Register: Assessing the Credibility of Computational Modeling and
Simulation in Medical Device Submissions
Federal
Register: Export of Medical Devices; Foreign Letters of Approval
|
|
January 26, 2022
ASCA
2021 Annual Report
Philips
Respironics Recalls Certain Trilogy EVO Ventilators for Potential
Health Risks from PE-PUR Foam
Update:
Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines
Recalled Due to Potential Health Risks: FDA Safety Communication
(Updated)
Philips
Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked
Questions (Updated)
|
|
January 25, 2022
Principles
for Selecting, Developing, Modifying, and Adapting Patient-Reported
Outcome Instruments for Use in Medical Device Evaluation - Guidance
for Industry and Food and Drug Administration Staff, And Other Stakeholders
Patient
Engagement in the Design and Conduct of Medical Device Clinical
Studies - Guidance for Industry, Food and Drug Administration Staff,
and Other Stakeholders
CDRH
Patient Engagement (Updated)
Clinical
Outcome Assessments (COAs) in Medical Device Decision Making (Updated)
Webinar
- Principles for Selecting, Developing, Modifying, and Adapting
Patient-Reported Outcome Instruments for Use in Medical Device Evaluation
- Final Guidance - March 1, 2022
Webinar
- Patient Engagement in the Design and Conduct of Medical Device
Clinical Studies - Final Guidance - March 22, 2022
Federal Register: Principles for Selecting, Developing, Modifying,
and Adapting Patient-Reported Outcome Instruments for Use in Medical
Device Evaluation
Federal
Register: Patient Engagement in the Design and Conduct of Medical
Device Clinical Studies
Virtual
Public Workshop –– Study Design Considerations for Transbronchoscopic
Thermal Ablation Devices for the Treatment of Oligometastases to
the Lung; April 5 & 6, 2022
|
|
January 24, 2022
New Emergency Use Authorizations
- DETECTR
BOOST SARS-CoV-2 Reagent Kit (Mammoth Biosciences, Inc.)
- MaximBio
ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.)
Updated Emergency Use Authorizations
- CareStart
COVID-19 Antigen Home Test (Access Bio, Inc.)
- Fast
Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers
Company)
- QuantiVirus
SARS-CoV-2 Multiplex Test Kit (DiaCarta, Inc.)
- Illumina
COVIDSeq Test (Illumina, Inc.)
- Viracor
SARS-CoV-2 assay DTC (Viracor Eurofins Clinical Diagnostics)
- Viracor
SARS-CoV-2 assay (Viracor Eurofins Clinical Diagnostics
- Diazyme
DZ-Lite SARS-CoV-2 IgG CLIA Kit (Diazyme Laboratories, Inc.)
- Diazyme
DZ-Lite SARS-CoV-2 IgM CLIA Kit (Diazyme Laboratories, Inc.)
- Dimension
Vista SARS-CoV-2 Total antibody assay (COV2T) (Siemens Healthcare
Diagnostics Inc.)
- Dimension
EXL SARS-CoV-2 Total antibody assay (CV2T) (Siemens Healthcare Diagnostics
Inc.)
- Atellica
IM SARS-CoV-2 IgG (sCOVG) (Siemens Healthcare Diagnostics Inc.)
Reissued Emergency Use Authorizations
- KPMAS
COVID-19 Test (Kaiser Permanente Mid-Atlantic States)
Revised Emergency Use Authorizations
- PKamp
Respiratory SARS-CoV-2 RT-PCR Panel 1 (PerkinElmer, Inc.)
- SARS-CoV-2
MassArray Test (National Jewish Health)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200059
added)
Federal
Register: Guidance on Reagents for Detection of Specific Novel Influenza
A Viruses
|
| January 22, 2022
At-Home
COVID-19 Diagnostic Tests: Frequently Asked Questions
|
|
January 21, 2022
Class
I Recall: Medtronic Inc. Recalls HawkOne Directional Atherectomy
System Due to Risk of Tip Damage During Use
In
Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2
(Added Single or Multiple Targets to the Attributes column)
In
Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2
(Added Single or Multiple Targets to the Attributes column)
COVID-19
Test Development and Review: FAQs on Testing for SARS-CoV-2 (Updated)
Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators
for COVID-19
- Mascarillas
faciales, cubiertas faciales de barrera, mascarillas quirúrgicas
y respiradores para el COVID-19 (Spanish)
- Yòng
yú 2019 xinguan fèiyán de miànzhào,
zugé xìng miànzhào, wàike kouzhào
hé huxi qì - Face shields, barrier masks, surgical
masks and respirators for COVID-19 (Simplified Chinese)
|
|
January 20, 2022
Federal
Register: Ophthalmic Devices; Classification of the Retinal Diagnostic
Software Device
Federal
Register: Immunology and Microbiology Devices; Classification of
Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests
Federal
Register: Emergency Use Authorization: In Vitro Diagnostic Devices
for Detection and/or Diagnosis of COVID-19; Revocation
|
|
January 19, 2022
Consumer
Information on: Optilume® Urethral Drug Coated Balloon –
P210020
Consumer
Information on: RHA Redensity - P170002/S012 (Dermal Filler)
Class
I Recall: Getinge USA Sales, LLC Recalls the Vaporizer Sevoflurane
Maquet Filling for Flow Family Anesthesia Systems Due to a Risk
of Harmful Chemical Exposure
UPDATE:
Blood Specimen Collection Tube Conservation Strategies - Letter
to Health Care and Laboratory Personnel
Blood
Specimen Collection Tube Shortage: Frequently Asked Questions (Updated)
Medical
Device Shortages During the COVID-19 Public Health Emergency (Updated)
|
|
January 18, 2022
New Emergency Use Authorizations
- iHealth
COVID-19 Antigen Rapid Test Pro (iHealth Labs, Inc.)
Reissued Emergency Use Authorizations
- covidSHIELD
(University of Illinois Office of the Vice President for Economic
Development and Innovation)
Updated Emergency Use Authorizations
- Detect
Covid-19 Test (Detect, Inc.)
- cobas
SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas
SARS-CoV-2) (Roche Molecular Systems)
- Viracor
SARS-CoV-2 assay (Viracor Eurofins Clinical Diagnostics)
- QuantiVirus
SARS-CoV-2 Test kit (DiaCarta, Inc)
- U-TOP
COVID-19 Detection Kit (SEASUN BIOMATERIALS)
- AQ-TOP
COVID-19 Rapid Detection Kit PLUS (SEASUN BIOMATERIALS, Inc.)
- INDICAID
COVID-19 Rapid Antigen Test (PHASE Scientific International, Ltd.)
Revoked Emergency Use Authorizations
- MosaiQ
COVID-19 Antibody Magazine (Quotient Suisse SA)
- BioPlex
2200 SARS-CoV-2 IgG (Bio-Rad Laboratories)
CDRH
Health of Women Program (Updated)
- Health
of Women 2022 Strategic Plan
Personal
Protective Equipment EUAs - Appendix A: Authorized Surgical Masks
(Updated)
Consumer
Information on: SLENDER Sirolimus-Eluting Coronary Stent Integrated
Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid
Exchange Delivery System – P210014
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|
January 15, 2022
Consumer
Information on: 4Kscore Test - P190022
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| January 14, 2022
Personal
Protective Equipment EUAs - Appendix A: Authorized Surgical Masks
(Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Consumer
Information on: SCOREFLEX NC SCORING PTCA CATHETER – P200041
Consumer
Information on: Edwards SAPIEN 3 Transcatheter Pulmonary Valve System
with Alterra Adaptive Prestent – P200015/S011
Medical
Device Types to Help Determine Section 506J Notification Obligations
(Updated)
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January 13, 2022
Update
on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular
AAA Graft Systems - FDA Safety Communication
510(k)
Third Party Performance Metrics and Accreditation Status (Updated)
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January 12, 2022
Updated Emergency Use Authorizations
- Personal
Protective Equipment EUAs Appendix A: Authorized Surgical Masks
Medical
Device Material Safety Summaries: ECRI Reports (Updated)
Federal
Register: Procedures for the Announcement of Approvals and Denials
of Premarket Approval Applications and Humanitarian Device Exemption
Applications
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January 11, 2022
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Stop
Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication
Consumer
Information on: OrganOx metra® System - P200035
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January 10, 2022
New Emergency Use Authorization
- PMLS
SARS-CoV-2 Assay (Premier Medical Laboratory Services)
Reissued Emergency Use Authorizations
- GWU
SARS-CoV-2 RT-PCR Test (George Washington University Public Health
Laboratory)
- COVID-19
At-Home Test (SD Biosensor, Inc.)
Updated Emergency Use Authorizations
- AQ-TOP
COVID-19 Rapid Detection Kit (Seasun Biomaterials, Inc.)
- cobas
SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas
SARS-CoV-2) (Roche Molecular Systems)
- cobas
SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the
cobas Liat System (Roche Molecular Systems, Inc.)
- FastPlex
Triplex SARS-CoV-2 detection kit (RT-Digital PCR) (PreciGenome LLC)
- PowerChek
2019-nCoV Real-time PCR Kit (KogeneBiotech Co., Ltd.)
- PKamp
Respiratory SARS-CoV-2 RT-PCR Panel 1 (PerkinElmer, Inc.)
- BinaxNOW
COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.)
- BinaxNOW
COVID-19 Ag Card Home 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.)
Notifying
FDA of a Permanent Discontinuance or Interruption in Manufacturing
of a Device Under Section 506J of the FD&C Act - Draft Guidance
for Industry and Staff
Class
I Recall: Cardiovascular Systems, Inc Recalls WIRION Embolic Protection
Device Due to Complaints of Filter Breakage During Retrieval
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN210015
added)
Federal
Register: Permanent Discontinuance or Interruption in Manufacturing
of a Device under the Federal Food, Drug, and Cosmetic Act
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|
January 7, 2022
Revoked Emergency Use Authorizations
- Xpert
Omni SARS-CoV-2 (Cepheid)
Revised Emergency Use Authorizations
- BinaxNOW
COVID-19 Antigen Self Test (Abbott Diagnostics Scarborough, Inc.)
Medical
Device Shortages During the COVID-19 Public Health Emergency (Updated)
Medical
Device Types to Help Determine Section 506J Notification Obligations
(Updated)
Consumer
Information on: SoftVue Automated Whole Breast Ultrasound System
with Sequr Breast Interface Assembly – P200040
|
|
January 6, 2022
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Class
I Recall: Medtronic Recalls Synergy Cranial and StealthStation S7
Cranial Software Due to Potential Risk of Inaccurate Biopsy Depth
Gauge Cycle View
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|
January 5, 2022
MedSun
Newsletter, January 2022
Summary
Minutes for October 6, 2021 Patient Engagement Advisory Committee
Meeting
|
|
January 4, 2022
GUDID
Data Trends - November 2021
Webinar
- Content of Premarket Submissions for Device Software Functions,
Draft Guidance - Presentation and Transcript added
|
|
January 3, 2022
Consumer Information on:
- Exablate
Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)
– P150038/S014
- VENTANA
PD-L1 (SP263) Assay – P160046/S010
- Oncomine
Dx Target Test – P160045/S029
Class
I Recall: Covidien, LP Recalls Puritan Bennett 980 Series Ventilator
Due to Manufacturing Assembly Error
MQSA
National Statistics as of January 1, 2022
|
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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