CDRHNew - News and Updates
A comprehensive list of the latest CDRH updates.
This Week in CDRH
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
- Updated Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- 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
- Digital Health Policy Navigator (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
- 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
- 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
- Revoked Emergency Use Authorizations
- 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
- 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
November 30, 2022
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
- Medical Device Development Tools (MDDT): CHemical RISk Calculator (CHRIS) - Color Additives
November 25, 2022
- Revised Emergency Use Authorization
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
- Updated Emergency Use Authorizations
- 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
- Updated Emergency Use Authorization
- 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
- 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
- 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
- Class I Recall - Insulet Recalls Omnipod DASH Insulin Management System's Personal Diabetes Manager (PDM)
November 15, 2022
- New Emergency Use Authorization
- 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
- 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)
- Federal Register: Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents
November 9, 2022
- New Emergency Use Authorization
- Updated Emergency Use Authorizations
November 8, 2022
- New Emergency Use Authorization
- Meeting Materials for November 10, 2022 Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting
November 7, 2022
- Updated Emergency Use Authorizations
- 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
- Updated Emergency Use Authorizations
- 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)
- Federal Register: Postmarket Surveillance of Medical Devices
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)
- Breakthrough Devices Program (Updated)
October 27, 2022
- Revised Emergency Use Authorizations
- 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
October 20, 2022
- Updated Emergency Use Authorizations
- Revoked Emergency Use Authorizations
- 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
- 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
- Revised Emergency Use Authorization
- 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
October 13, 2022
- Updated Emergency Use Authorizations
- 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
- Revised Emergency Use Authorization
- 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
- 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
- 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