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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.
| April 19, 2024 - FDA
Roundup: April 19, 2024 |
| April 16, 2024 - FDA
Roundup: April 16, 2024 |
| April 12, 2024 - FDA
Roundup: April 12, 2024 |
| April 9, 2024 - Federal
Court Enters Consent Decree Against Philips Respironics Following
Recall of Certain Sleep Therapy Machines |
| April 9, 2024 - FDA
Roundup: April 9, 2024 |
| April 5, 2024 - FDA
Roundup: April 5, 2024 |
| April 3, 2024 - FDA
Approves New Antibiotic for Three Different Uses |
| April 2, 2024 - FDA
Roundup: April 2, 2024 |
| March 29, 2024 - FDA
Roundup: March 29, 2024 |
| March 26, 2024 - FDA
Warns Consumers to Avoid Certain Topical Pain Relief Products Due
to Potential for Dangerous Health Effects |
| March 26, 2024 - FDA
Roundup: March 26, 2024 |
| March 22, 2024 - FDA
Roundup: March 22, 2024 |
| March 21, 2024 - FDA
Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy |
| March 19, 2024 - FDA
Roundup: March 19, 2024 |
| March 18, 2024 - FDA
Approves First Gene Therapy for Children with Metachromatic Leukodystrophy |
|
March 15, 2024 - FDA
Roundup: March 15, 2024
|
| March 14, 2024 - FDA
Approves First Treatment for Patients with Liver Scarring Due to Fatty
Liver Disease |
| March 12, 2024 - FDA
Roundup: March 12, 2024 |
| March 11, 2024 - FDA
Seeks $7.2 Billion to Enhance Food Safety and Nutrition, Advance Medical
Product Safety, and Strengthen Public Health |
| March 8, 2024 - FDA
Approves First Treatment to Reduce Risk of Serious Heart Problems
Specifically in Adults with Obesity or Overweight |
| March 8, 2024 - FDA
Roundup: March 8, 2024 |
| March 6, 2024 - FDA
Takes Steps to Ensure Safety of Cinnamon Products Sold in the US |
| March 5, 2024 - FDA
Roundup: March 5, 2024 |
| March 5, 2024 - FDA
Clears First Over-the-Counter Continuous Glucose Monitor |
| March 1, 2024 - FDA
Roundup: March 1, 2024 |
| February 28, 2024 - FDA,
Industry Actions End Sales of PFAS Used in US Food Packaging |
| February 27, 2024 - FDA
Roundup: February 27, 2024 |
| February 23, 2024 - FDA
Roundup: February 23, 2024 |
| February 20, 2024 - FDA
Roundup: February 20, 2024 |
| February 16, 2024 - FDA
Approves First Cellular Therapy to Treat Patients with Unresectable
or Metastatic Melanoma |
| February 16, 2024 - FDA
Approves First Medication to Help Reduce Allergic Reactions to Multiple
Foods After Accidental Exposure |
| February 16, 2024 - FDA
Roundup: February 16, 2024 |
| February 14, 2024 - FDA
Approves First Medication to Treat Severe Frostbite |
| February 13, 2024 - FDA
Roundup: February 13, 2024 |
| February 9, 2024 - FDA
Roundup: February 9, 2024 |
| February 6, 2024 - FDA
Roundup: February 6, 2024 |
| February 2, 2024 - FDA
Roundup: February 2, 2024 |
| January 30, 2024 - FDA
Roundup: January 30, 2024 |
| January 26, 2024 - FDA
Roundup: January 26, 2024 |
| January 23, 2024 - FDA
Roundup: January 23, 2024 |
| January 19, 2024 - FDA
Roundup: January 19, 2024 |
| January 16, 2024 - FDA
Roundup: January 16, 2024 |
| January 12, 2024 - FDA
Roundup: January 12, 2024 |
| January 9, 2024 - FDA
Roundup: January 9, 2024 |
| January 8, 2024 - FDA
Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical
Device Sterilization |
| January 5, 2024 - FDA
Authorizes Florida’s Drug Importation Program |
| January 5, 2024 - FDA
Roundup: January 5, 2024 |
| January 2, 2024 - FDA
Roundup: January 2, 2024 |
For the most up to date FDA headlines, see the FDA
Medical Device News page.
| April 19, 2024
Updated Emergency Use Authorization
- The
AscencioDx COVID-19 Test and The AscencioDx Molecular Detector (ADL
Diagnostics, Inc., dba Anavasi Diagnostics)
Revoked Emergency Use Authorization
- FTD
SARS-CoV-2 (Fast Track Diagnostics Luxembourg S.à.r.l.)
Risks
with Exactech Equinoxe Shoulder System with Defective Packaging
- FDA Safety Communication (Updated)
|
|
April 17, 2024
CDRH
Statement: CDRH Issues 2024 Safety and Innovation Reports
Medical
Device Safety and Innovation Reports (Updated)
Current
Career Opportunities at CDRH (Updated)
Class
I Recall: Boston Scientific Recalls Obsidio Conformable Embolic
for Increased Bowel Ischemia Risk When Used for Lower GI Bleeding
Class
I Recall: Fresenius Kabi USA, LLC Recalls Ivenix Infusion Pump LVP
Software for Anomalies That Have the Potential to Cause Serious
Patient Harm or Death
|
|
April 16, 2024
CDRH
Unveils New Dataset to Help Improve Chemical Characterization Methods
for Biocompatibility of Medical Devices
Manufacturer
and User Facility Device Experience (MAUDE) (Updated)
CDRH
Petitions (Updated)
|
|
April 15, 2024
Revised Emergency Use Authorization
- Aptitude
Medical Systems Inc.: Metrix COVID-19 Test
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
Class
I Recall: Abbott/Thoratec Corp. Recalls HeartMate II and HeartMate
3 Left Ventricular Assist System (LVAS) due to Long-term Buildup
Causing an Obstruction
Medical
Device Sterilization Town Hall: Topics and Formats for the Continuing
Sterilization Series, April 29, 2024
Sterilization
for Medical Devices (Updated)
|
| April 11, 2024
MedSun
Newsletter - April 2024
Stress
Urinary Incontinence: Surgical Mesh Considerations and Recommendations
(Updated)
|
|
April 10, 2024
New Emergency Use Authorization
- CorDx
TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
FDA
Activities Related to Recalled Philips Ventilators, BiPAP Machines,
and CPAP Machines (Updated)
Foam
Testing Summary for Recalled Philips Ventilators, BiPAP Machines,
and CPAP Machines (Updated)
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
COVID-19
Tests Granted Traditional Marketing Authorization by the FDA (Updated)
ASCA-Accredited
Testing Laboratories (Updated)
|
|
April 9, 2024
Problems
Reported With Essure (Updated)
Information
for Patients and Health Care Providers: Essure (Updated)
FDA
Activities Related to Essure (Updated)
|
|
April 8, 2024
New Emergency Use Authorization
- QuickFinder
COVID-19/Flu Antigen Self Test (OSANG LLC)
Re-issued Emergency Use Authorizations
- ePlex
Respiratory Pathogen Panel (GenMark Diagnostics, Inc.)
|
|
April 4, 2024
New Emergency Use Authorization
- SalivaNow
SARS-CoV-2 Assay (LMSI, LLC d/b/a Lighthouse Lab Services)
ASCA-Accredited
Testing Laboratories (Updated)
Class
I Recall:
Smiths Medical ASD Recalls PneuPac ParaPAC Plus 300 and 310 Ventilator
Kits for a Malfunction Causing Non-Cycling, Continuous Positive
Gas Flow and Preventing Proper Ventilation
Class
I Recall: Medos International Sàrl Recalls Cerenovus CEREBASE
DA Guide Sheath due to Cracking of the Distal Catheter Shaft
Federal
Register: Device Good Manufacturing Practice Advisory Committee
Federal
Register: Voting Members for the Patient Engagement Advisory Committee
|
|
April 3, 2024
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
Class
I Recall: Teleflex and Arrow International Recall ARROW QuickFlash
Radial Artery and Radial Artery/Arterial Line Catheterization Kits
for Increased Resistance That May Lead to Vessel Injuries, Narrowing,
or Blockage
Reports
to Congress (Updated)
- FY 2021 Premarket Approval of Pediatric Uses of Devices
Medical
Device Development Tools (MDDT) (Updated)
|
|
April 2, 2024
Current
Career Opportunities at CDRH (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries - Sleep Apnea
Feature - DEN230041
|
|
April 1, 2024
CDRH
Learn (Updated)
- Presentation and Transcript for Medical Device Sterilization Town
Hall: The Value and Use of Recognized Consensus Standards in Premarket
Submissions - March 21, 2024
Standards
Newsletter from the Division of Standards and Conformity AssessmentExternal
Link Disclaimer
MQSA
National Statistics (Updated)
|
| March 29, 2024
eSTAR
Program (Updated)
|
|
March 28, 2024
Animal
Studies for Dental Bone Grafting Material Devices - Premarket Notification
(510(k)) Submissions - Draft Guidance for Industry and Food and
Drug Administration Staff
Co-sponsored
Public Meeting - Food and Drug Administration/Medical Device Innovation
Consortium Symposium on Computational Modeling and Simulation -
April 16-17, 2024
Mammography
Quality Standards Act and Program (Updated)
Mammography
Quality Standards Act - Facility Accreditation and Certification
(Updated)
Mammography
Quality Standards Act - Inspection Resources
Federal
Register: Animal Studies for Dental Bone Grafting Material Devices
- Premarket Notification (510(k)) Submissions
|
|
March 27, 2024
ASCA
Consolidated Pilot Final Report and 2023 Annual Report
Evaluation
of Automatic Class III Designation (De Novo) Summaries - Invitae
Common Hereditary Cancers Panel (DEN210011)
|
|
March 26, 2024
New Emergency Use Authorizations
- Labcorp
Monkeypox PCR Test Home Collection Kit (LabCorp)
- Non-variola
Orthopoxvirus Real-time PCR Primer and Probe Set - EUA (Centers
for Disease Control and Prevention (CDC))
Evaluation
of Automatic Class III Designation (De Novo) Summaries - Body Temperature
Software (BTS) (DEN230050), Sonu (DEN230045), X100 with Full Field
Bone Marrow Aspirate (BMA) Application, X100HT with Full Field Bone
Marrow Aspirate (BMA) Application (DEN230034)
Total
Product Life Cycle Advisory Program (TAP) (Updated)
|
|
March 25, 2024
CDRH
Statement: FDA Proposes New Ban of Electrical Stimulation Devices
for Self-Injurious or Aggressive Behavior
Medical
Device Bans (Updated)
Class
I Recall: Medline Industries Recalls Certain Kits and Trays Containing
Sterile Water Based Products Under Recall by Nurse Assist
24
Hour Summary and Presentations for March 21, 2024 Ophthalmic Devices
Panel of the Medical Devices Advisory Committee Meeting
Federal
Register: Banned Devices: Proposal to Ban Electrical Stimulation
Devices for Self-Injurious or Aggressive Behavior
|
| March 21, 2024
Class
I Recall: Abiomed Recalls the Instructions for Use for Impella Left
Sided Blood Pumps due to Perforation Risks
Class
I Recall: Vyaire Medical, Inc. Recalls AirLife Manual Resuscitators
Due to Manufacturing Defect That Can Lead to Injury or Death
Breakthrough
Devices Program (Updated)
|
|
March 20, 2024
New Emergency Use Authorization
- EZ-SARS-CoV-2
Real-Time RT-PCR (Tetracore, Inc.)
Transcript
and Summary Minutes for February 13, 2024 Circulatory System Devices
Panel of the Medical Devices Advisory Committee Meeting
Federal
Register: Emergency Use Authorization: In Vitro Diagnostic Device
for Detection and/or Diagnosis of COVID-19; Revocation
Federal
Register: Voluntary Total Product Life Cycle Advisory Program Pilot
|
|
March 19, 2024
CDRH
Statement: FDA Provides Update on Plastic Syringes Made in China,
Issues Warning Letters Related to Violative Products
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication
Materials
for March 21, 2024 Ophthalmic Devices Panel of the Medical Devices
Advisory Committee Meeting
|
|
March 18, 2024
Co-sponsored
Public Conference – Food and Drug Administration/Advanced Medical
Technology Association Medical Device Statistical Issues - April
2-3, 2024
|
| March 15, 2024
Artificial
Intelligence and Machine Learning in Software as a Medical Device
(Updated)
Consumer Information: Belotero
Balance® (+) - P090016/S050
(Merz North America, Inc.)
|
|
March 14, 2024
Evaluation
of Thermal Effects of Medical Devices that Produce Tissue Heating
and/or Cooling - Guidance for Industry and Food and Drug Administration
Staff
Requests
for Feedback and Meetings for Medical Device Submissions: The Q-Submission
Program - Draft Guidance for Industry and Food and Drug Administration
Staff
Medical
Device Sterilization Town Hall: The Value and Use of Recognized
Consensus Standards in Premarket Submissions - March 21, 2024
Sterilization
for Medical Devices (Updated)
Class
I Recall: Avanos Recalls MIC Gastric – Jejunal Feeding Tube
Kits Containing Sterile Water Based Products Under Recall by Nurse
Assist
Federal
Register: Medical Devices; Technical Amendments
Federal
Register: Evaluation of Thermal Effects of Medical Devices That
Produce Tissue Heating and/or Cooling
Federal
Register: Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program
|
|
March 13, 2024
Federal
Register: Select Updates for the Premarket Cybersecurity Guidance:
Section 524B of the Federal Food, Drug, and Cosmetic Act; Draft
Guidance for Industry and Food and Drug Administration Staff
|
|
March 12, 2024
Select
Updates for the Premarket Cybersecurity Guidance: Section 524B of
the FD&C Act - Draft Guidance for Industry and Food and Drug
Administration Staff
Webinar
- Draft Guidance: Select Updates for the Premarket Cybersecurity
Guidance: Section 524B of the FD&C Act - April 30, 2024
Cybersecurity
(Updated)
|
|
March 11, 2024
CDRH
Statement: CDRH Welcomes 25th Session of the International Medical
Device Regulators Forum
Collaborative
Communities: Addressing Health Care Challenges Together (Updated)
Class
I Recall: Windstone Medical Packaging, Inc. Recalls Local Lower
Extremity Pack, In House Ocular Pack and Closure Kit Containing
Sterile Water Based Products Under Recall by Nurse Assist
Class
I Recall: Abbott Recalls HeartMate Touch Communication System for
Unintentional Pump Start and Stop
|
| March 8, 2024
CDRH's
Experiential Learning Program (ELP) (Updated)
MDUFA
Reports (Updated)
- March 8, 2024, MDUFA V Performance Report
|
|
March 7, 2024
Updated Emergency Use Authorization
- The
AscencioDx COVID-19 Test and The AscencioDx Molecular Detector (ADL
Diagnostics, Inc., dba Anavasi Diagnostics)
MedSun
Newsletter - March 2024
Class
I Recall: Medtronic Neurosurgery Recalls Duet External Drainage
and Monitoring System Catheter Tubing due to a Potential for the
Catheter Disconnection from the Patient Line Stopcock Connectors
Class
I Recall: Ventec Life Systems Recalls VOCSN Patient Breathing Package
(Pediatric, Active, Oxygen, Blue) for Manufacturing Issue with Bonded
Spiral Wrap
Class
I Recall: Cardinal Health Recalls Sterile Monoject Luer-Lock and
Enteral Syringes Due to a Change in Manufacturing (Updated)
CDRH
Learn (Updated)
- Presentation and Transcript for Medical Device Sterilization Town
Hall: FDA’s Modifications Guidances and the Use of Device Master
Files in Reviews - February 29, 2024
|
|
March 6, 2024
Dispositivos
médicos de realidad aumentada y realidad virtual: preguntas
que debe considerar
Augmented
Reality and Virtual Reality Medical Devices: Questions to Consider
(Updated)
Class
I Recall: Baxter Healthcare Recalls ExactaMix Pro 1200 and Pro 2400
Due to a Software Error
|
|
March 5, 2024
Medical
Device Single Audit Program (MDSAP) (Updated)
Class
I Recall: Smiths Medical ASD Inc. Recalls Medfusion Model 3500 Syringe
Pump Due to Issues Associated with Earlier Software Versions
Explore
Life at CDRH (Updated)
|
|
March 4, 2024
Federal
Register Documents (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries - OMNIgeneGUT
DX (DEN200040)
|
|
March 1, 2024
New Emergency Use Authorization
- OSOM
Flu SARS-CoV-2 Combo Test (SEKISUI Diagnostics, LLC)
- OSOM
Flu SARS-CoV-2 Combo Home Test (SEKISUI Diagnostics, LLC.)
Class
I Recall: Megadyne Medical Products, Inc. Recalls Mega Soft Universal
Patient Return Electrode Due to Reports of Patient Burns (Updated)
Class
I Recall: Datex-Ohmeda Recalls EVair Air Compressors Due to Formaldehyde
Emissions Found in Specific Conditions When Used with CARESCAPE
R860, Engstrom Carestation or Pro Ventilators
MQSA
National Statistics (Updated)
|
| February 29, 2024
Follow
Instructions for Safe Use of Electrical Operating Room Tables -
Letter to Health Care Providers
COVID-19
Tests Granted Traditional Marketing Authorization by the FDA (Updated)
Transcript:
February 6, 2024 General Hospital and Personal Use Devices Panel
of the Medical Devices Advisory Committee Meeting
Class
I Recall: Wipro GE Healthcare Private Ltd. Recalls Care Plus, Care
Plus models 1000-4000 and Lullaby Incubators Due to Problems with
Door Latch
Hintermann
Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk
of Device Failure: FDA Safety Communication
Federal
Register: Food and Drug Administration Modernization Act: List of
Recognized Standards, Recognition List Number: 061
|
|
February 28, 2024
Virtual
Public Workshop – Accreditation Scheme for Conformity Assessment
Expansion - April 17, 2024
Class
I Recall: Olympus Corporation of the Americas Recalls Bronchofiberscopes
and Bronchovideoscopes Because They Can Lead to Burns and Fire (Updated)
CDRH
Statement: CDRH’s Continued Commitment to Breast Implant Safety
Transcript
and Summary Minutes for February 2, 2024 Anesthesiology and Respiratory
Therapy Devices Panel of the Medical Devices Advisory Committee
Meeting
Federal
Register: Medical Device User Fee Cover Sheet and Device Facility
User Fee Cover Sheet
|
|
February 27, 2024
BioZorb
Markers and Potential Risks with Use in Breast Tissue: FDA Safety
Communication
|
|
February 26, 2024
Updated Emergency Use Authorization
- Abbott
RealTime Zika (Abbott Molecular Inc.)
Medical
Device Sterilization Town Hall: FDA’s Modifications Guidances
and the Use of Device Master Files in Reviews
|
| February 23, 2024
Revoked Emergency Use Authorizations
- xMAP
SARS-CoV-2 Multi-Antigen IgG Assay (Luminex Corporation)
|
|
February 22, 2024
Diagnostic
Data Program (Updated)
Systemic
Harmonization and Interoperability Enhancement for Laboratory Data
(SHIELD) (Updated)
Digital
Diagnostics: Over-the-Counter (OTC) and Point-of-Care (POC) (Updated)
|
|
February 21, 2024
Select
Updates for the Medical Device User Fee Small Business Qualification
and Certification Guidance - Guidance for Industry and Food and
Drug Administration Staff
Reduced
Medical Device User Fees: Small Business Determination (SBD) Program
(Updated)
Update:
Recommendations for Certain Medtronic Electromyogram Endotracheal
Tubes and Risk of Airway Obstruction - Letter to Health Care Providers
(Updated)
Do
Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels:
FDA Safety Communication
Federal
Register: List of Standing Committees: Digital Health Advisory Committee
Federal
Register: Select Updates for the Medical Device User Fee Small Business
Qualification and Certification Guidance; Agency Information Collection
Activities
|
|
February 20, 2024
Fraudulent
and Unreliable Laboratory Testing Data in Premarket Submissions:
FDA Reminds Medical Device Manufacturers to Scrutinize Third-Party-Generated
Data
|
| February 15, 2024
Class
I Recall: Philips Recalls BrightView Imaging Systems Due to the
Detector Unexpectedly Falling
|
|
February 14, 2024
Class
I Recall: Smiths Medical ASD Inc. Recalls Medfusion Model 4000 Syringe
Pump Due to Issues Associated with Earlier Software Versions
|
|
February 13, 2024
Presentations
for February 2, 2024 Anesthesiology and Respiratory Therapy Devices
Panel of the Medical Devices Advisory Committee Meeting
|
| February 9, 2024
Materials
for February 13, 2024 Circulatory System Devices Panel of the Medical
Devices Advisory Committee Meeting
Presentations
for February 6, 2024 General Hospital and Personal Use Devices Panel
of the Medical Devices Advisory Committee Meeting
MedSun
Newsletter - February 2024
|
|
February 8, 2024
Current
Career Opportunities at CDRH
24
Hour Summary for February 2, 2024 Anesthesiology and Respiratory
Therapy Devices Panel of the Medical Devices Advisory Committee
Meeting
24
Hour Summary for February 6, 2024 General Hospital and Personal
Use Devices Panel of the Medical Devices Advisory Committee Meeting
|
|
February 7, 2024
International
Medical Device Regulators Forum (IMDRF) (Updated)
CDRH
International Affairs (Updated)
Consumer Information: Edwards
EVOQUE Tricuspid Valve Replacement System - P230013
(Edwards Lifesciences, LLC)
|
|
February 6, 2024
Updated Emergency Use Authorization
- The
AscencioDx COVID-19 Test and The AscencioDx Molecular Detector (ADL
Diagnostics, Inc.)
- iHealth
COVID-19 Antigen Rapid Test Pro (iHealth Labs, Inc.)
At-Home OTC COVID-19 Diagnostic Tests (Updated)
- BinaxNOW
COVID-19 Antigen Self Test (Abbott Diagnostics Scarborough, Inc.)
- Extended Expiration Date
Meeting
Notice: March 21, 2024 Ophthalmic Devices Panel of the Medical Devices
Advisory Committee
Recall
of Certain Saline and Sterile Water Medical Products Associated
with Nurse Assist: FDA Safety Communication (Updated)
Class
I Recall: Percussionaire Recalls High Frequency Transport Phasitron
Breathing Circuit Kits for Over-Pressurization
|
|
February 5, 2024
CDRH Learn (Updated)
- Presentation
and Transcript for Medical Device Sterilization Town Hall: FDA Activities
and Challenges in Reducing Reliance on Ethylene Oxide (EtO) - January
26, 2024
Federal
Register: Emergency Use Authorization: In Vitro Diagnostic Device
for Detection and/or Diagnosis of COVID-19; Revocation
Federal
Register: Hearings, Meetings, Proceedings, etc.: Ophthalmic Devices
Panel of the Medical Devices Advisory Committee, FSYX Ocular Pressure
Adjusting Pump System
|
|
February 2, 2024
Do
Not Use Certain Cardinal Health Monoject Luer-Lock and Enteral Syringes
- FDA Safety Communication
At-Home
OTC COVID-19 Diagnostic Tests (Updated Xiamen Boson Biotech Co.,
Ltd. Rapid SARS-CoV-2 Antigen Test Card)
Materials
for February 6, 2024 General Hospital and Personal Use Devices Panel
of the Medical Devices Advisory Committee Meeting
|
|
February 1, 2024
Re-issued Emergency Use Authorizations
- Respiratory
SARS-CoV-2 RT-PCR Panel 1 (Revvity, Inc.)
- New
Coronavirus Nucleic Acid Detection Kit (Revvity, Inc.)
CDRH's
Experiential Learning Program (ELP) (Updated)
COVID-19 Tests Granted Traditional Marketing Authorization by the
FDA (Updated)
- Biofire®
Spotfire® Respiratory (R) Panel Mini (Biofire Diagnostics, LLC)
MQSA
National Statistics (Updated)
Total
Product Life Cycle Advisory Program (TAP) (Updated)
Medical
Device Shortages List (Updated)
Medical
Device Sterilization Town Hall: Discussion of Premarket Submission
Expectations and Additional Considerations for Sterility Review
- February 7, 2024
Federal
Register: Medical Devices; Quality System Regulation Amendments
|
| January 31, 2024
Materials
for February 2, 2024 Anesthesiology and Respiratory Therapy Devices
Panel of the Medical Devices Advisory Committee Meeting
Mammography
Quality Standards Act and Program (Updated)
Quality
Management System Regulation: Final Rule Amending the Quality System
Regulation – Frequently Asked Questions (Updated)
Quality
and Compliance (Medical Devices) (Updated)
Overview
of Device Regulation (Updated)
Quality
System (QS) Regulation/Medical Device Current Good Manufacturing
Practices (CGMP) (Updated)
Class
I Recall: Maquet Cardiovascular, LLC Recalls Atrium Express Dry
Suction Dry Seal Chest Drain Containing Sterile Water Based Products
Under Recall by Nurse Assist
Consumer Information: Aurora
EV-ICD System - P220012
(Medtronic, Inc.)
Problems
Reported with Recalled Philips Ventilators, BiPAP Machines, and
CPAP Machines (Updated)
CDRH
Announces Intent to Initiate the Reclassification Process for Most
High Risk IVDs
Federal
Register: Medical Devices; Quality System Regulation Amendments
|
|
January 30, 2024
Class
I Recall: Globus Medical, Inc. Recalls ExcelsiusGPS Flat Panel Fluoroscopy
Registration Fixture Due to a Calibration Error
|
|
January 29, 2024
Updated Emergency Use Authorization
- UOL
COVID-19 Test (Uh-Oh Labs Inc.)
CDRH
Statement on Philips’ Announcement
|
| January 26, 2024
ASCA-Accredited
Testing Laboratories (Updated)
Consumer Information - OncomineTM
Dx Target Test - P160045/S025
(Life Technologies Corporation)
|
|
January 25, 2024
Revised Emergency Use Authorization
- Rapid
SARS-CoV-2 Antigen Test Card (Xiamen Boson Biotech Co., Ltd.)
|
|
January 24, 2024
FDA
Elevates Office of Strategic Partnerships and Technology Innovation
to Super Office in CDRH
Recall of Certain Saline and Sterile Water Medical Products Associated
with Nurse Assist: FDA Safety Communication (Updated)
- Windstone
Medical Packaging dba Aligned Medical Solutions
Federal
Register: Emergency Use Authorization: Certain Medical Devices during
COVID-19
|
|
January 23, 2024
CLIA
Waiver by Application Decision Summaries (Updated)
Medical
Device Sterilization Town Hall: FDA Activities and Challenges in
Reducing Reliance on Ethylene Oxide (EtO)
|
|
January 22, 2024
Characterization
of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic
Devices - Draft Guidance for Industry and Food and Drug Administration
Staff
ASCA-Accredited
Testing Laboratories (Updated)
CDRH Learn (Updated)
- Presentation
and Transcript for Webinar - Assessing the Credibility of Computational
Modeling and Simulation in Medical Device Submissions Final Guidance
- January 11, 2024
Federal
Register: Characterization of Metallic Coatings and/or Calcium Phosphate
Coatings on Orthopedic Devices
|
| January 19, 2024
Meeting
Notice: February 13, 2024 Circulatory System Devices Panel of the
Medical Devices Advisory Committee
Ventilators
and Ventilator Accessories EUAs (Updated)
|
|
January 18, 2024
FDA
and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests,
Wherever They Are Made
CDRH Learn (Updated)
- Presentation
and Transcript for Medical Device Sterilization Town Hall: Overview
of Sterilization Landscape and Role of Ethylene Oxide - January
10, 2024
Certain
ResMed Ltd Masks for BiPAP, CPAP Machines Recalled Due to Safety
Issue with Magnets That May Affect Certain Medical Devices: FDA
Safety Communication
Historical
Information about Device Emergency Use Authorizations (Updated)
|
|
January 17, 2024
CDRH
2023 Annual Report
Recall
of Certain Saline and Sterile Water Medical Products Associated
with Nurse Assist: FDA Safety Communication (Updated)
CDRH
Petitions (Updated)
CLIA
Waiver by Application Decision Summaries (Updated)
|
|
January 16, 2024
Megadyne
Medical Products, Inc. Recalls Mega Soft Universal Patient Return
Electrode Due to Reports of Patient Burns (Updated)
Class
I Recall: ROi CPS, LLC Recalls Regard Operative Lap P&S Surgical
Kit Due to Possible Lack of Sterility
Risks
with Exactech Equinoxe Shoulder System with Defective Packaging
- FDA Safety Communication
|
| January 12, 2024
Important
Information: Final Rule to Amend the Mammography Quality Standards
Act (MQSA)
Class
I Recall: Fresenius Kabi USA, LLC Recalls Ivenix Large Volume Pump
(LVP) of the Ivenix Infusion System Due to Mechanical Interference
Report
to Congress: Device Pilot Projects FY 2022
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January 11, 2024
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Class
I Recall: Busse Hospital Disposables, Inc. Recalls Care Trays and
Kits Containing Sterile Water Based Products Under Recall by Nurse
Assist
Class
I Recall: ResMed Ltd. Recalls Continuous Positive Airway Pressure
(CPAP) Masks with Magnets due to Possible Magnetic Interference
with Certain Medical Devices
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January 10, 2024
V-CHAMPS
Challenge Winners
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January 9, 2024
Potential
Exposure to Certain Chemicals with Use of GE HealthCare EVair and
EVair03 Compressors with Certain Ventilators – Letter to Health
Care Providers
Transcript
and Summary Minutes: November 29, 2023 Molecular and Clinical Genetics
Panel of the Medical Devices Advisory Committee Meeting
Transcript
and Summary Minutes: AMENDED INFORMATION: October 20, 2022 Clinical
Chemistry and Clinical Toxicology Devices Panel of the Medical Devices
Advisory Committee Meeting Announcement
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
- InteliSwab COVID-19 Rapid Test (OraSure Technologies, Inc.) -
Extended Expiration Date
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January 8, 2024
Revised Emergency Use Authorization
- Advin
COVID-19 Antigen Test @Home (Advin Biotech Inc.)
Submission
and Review of Sterility Information in Premarket Notification (510(k))
Submissions for Devices Labeled as Sterile - Guidance for Industry
and Food and Drug Administration Staff (Updated)
Sterilization
for Medical Devices (Updated)
Transcript:
September 6, 2023 Patient Engagement Advisory Committee Meeting
Class
I Recall: Insulet Corporation Recalls Omnipod 5 Android App due
to a Software Error
Class
I Recall: Megadyne Medical Products, Inc. Recalls Mega Soft Universal
Patient Return Electrode Due to Reports of Patient Burns
Medical
Device Sterilization Town Hall: Overview of Sterilization Landscape
and Role of Ethylene Oxide - January 10, 2024
|
|
January 5, 2024
Recall
of Certain Saline and Sterile Water Medical Products Associated
with Nurse Assist: FDA Safety Communication (Updated)
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|
January 4, 2024
ASCA-Accredited
Testing Laboratories (Updated)
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|
January 3, 2024
Updated Emergency Use Authorizations
- Rapid
SARS-CoV-2 Antigen Test Card (Xiamen Boson Biotech Co., Ltd.)
- Lucira
by Pfizer COVID-19 & Flu Home Test (Pfizer Inc.)
Evaluation
of Airborne Chemicals from Neonatal Incubators - Letter to Health
Care Providers (Updated)
Do
Not Use Synovo Total Hip Resurfacing System: FDA Safety Communication
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|
January 2, 2024
Transition
to Electronic Export Documents - Letter to Industry
MedSun
Newsletter - January 2024
MQSA
National Statistics (Updated)
|
See the current
MedSun newsletter at the FDA website for Recalls and Safety Alerts,
Highlighted Reports, and Links to FDA/CDRH Databases and Other Information
Sources.
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