CDRHNew - News and Updates
A comprehensive list of the latest CDRH updates.
This Week in CDRH
September 15, 2023
- Digital Health Frequently Asked Questions (FAQs)
- Virtual Public Workshop – Patient-Reported Outcomes and Vision Related Quality of Life Questionnaires, September 29, 2023 - 09/29/2023
September 14, 2023
- Medical Devices with Indications Associated with Weight Loss - Clinical Study and Benefit-Risk Considerations - Draft Guidance for Industry and Food and Drug Administration Staff
- Medical Devices with Indications Associated with Weight Loss - Non-Clinical Recommendations - Draft Guidance for Industry and Food and Drug Administration Staff
- Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program - Guidance for Industry and Food and Drug Administration Staff
- Weight-Loss and Weight-Management Devices (Updated)
- Breakthrough Devices Program - Guidance for Industry and Food and Drug Administration Staff
- Breakthrough Devices Program (Updated)
- CDRH Statement: CDRH Issues Updated Final Guidance on Breakthrough Devices Program
- Webinar - Breakthrough Devices Program Updated Final Guidance - November 14, 2023
- Federal Register: Medical Devices with Indications Associated with Weight Loss Guidances
- Federal Register: Fostering Medical Device Improvement: Food and Drug Administration Activities and Engagement with the Voluntary Improvement Program
- Federal Register: Breakthrough Devices Program
September 13, 2023
- MDUFA Reports (Updated)
- September 11, 2023 MDUFA V Performance Report
- September 11, 2023 MDUFA IV Performance Report
- Class I Recall: Abbott Medical Recalls Proclaim and Infinity IPGs for Inability to Exit Magnetic Resonance Imaging (MRI) Mode
September 12, 2023
September 8, 2023
- New Emergency Use Authorization
- ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test (Princeton BioMeditech Corp.)
- Updated Emergency Use Authorizations
- Voluntary eSTAR Program (Templates updated)
- Postmarket Device Safety-Related Communications Report to Congress
- Total Product Life Cycle Advisory Program (TAP) (Updated)
- Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication (Updated)
- MedSun Newsletter - September 2023
September 7, 2023
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff
- Webinar - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Final Guidance - October 12, 2023
- Basics of Biocompatibility: Information Needed for Assessment by the FDA (Updated)
- Glossary of Biocompatibility Terms (Updated)
- What Should I Put in a Test Report? (Updated)
- Biocompatibility Evaluation Endpoints by Device Category (Updated)
- Biocompatibility Evaluation Endpoints by Contact Duration Periods (Updated)
- Component and Device Documentation Examples for Test Articles or Previously Marketed Devices (Updated)
- Consumer Information: CraniSeal Dural Sealant - P220014 (Pramand, LLC)
- August 2023 PMA Approval Listing (Updated)
September 6, 2023
- Evidentiary Expectations for 510(k) Implant Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions - Draft Guidance for Industry and Food and Drug Administration Staff
- Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission - Draft Guidance for Industry and Food and Drug Administration Staff
- Webinar - CDRH's New Draft Guidances to Continue to Modernize the 510(k) Program - October 26, 2023
- CDRH Statement: FDA Continues to Take Steps to Strengthen the Premarket Notification [510(k)] Program
- FDA Continues to Take Steps to Strengthen the Premarket Notification [510(k)] Program - Program Updates
- 510(k) Program Evaluations and Reports
- Total Product Life Cycle for Medical Devices
- 510(k) Clearances
- Medical Device Safety and the 510(k) Clearance Process
- STEM Career Opportunities at CDRH (Updated)
- Federal Register: Modernizing the Premarket Notification Program
September 5, 2023
- Enforcement Policy for Face Masks and Barrier Face Coverings for Coronavirus Disease (COVID-19) Response - Guidance for Industry and Food and Drug Administration Staff
- Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19 (Updated)
- STEM Career Opportunities at CDRH (Added Executive Officer / Office Director (OM) - CURES)
- FDA Offers Tips about Medical Devices and Natural Disasters (Updated)
- Emergency Preparedness and Medical Devices: Supply Chain Recommendations for Health Care Providers, Device Manufacturers, and Distributors (Updated)
- eMDR System Enhancements (Updated)
- Coding Resources for Medical Device Reports (Updated)
- Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files (Updated)
- Consumer Information on: HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads – P200007
September 1, 2023
- Augmented Reality and Virtual Reality Medical Devices: Questions to Consider
- Materials posted for September 6, 2023 Patient Engagement Advisory Committee Meeting
- Webinar - Qualification of Medical Device Development Tools - September 12, 2023
- Total Product Life Cycle Advisory Program (TAP) (Updated)
- MQSA National Statistics (Updated)
- 510(k) Third Party Performance Metrics and Accreditation Status (Updated)
- Consumer Information: Minitouch 3.8 Era System - P230002 (MicroCube, LLC)
- Consumer Information: SurVeil Drug-Coated Ballon - P210025 (Surmodics, Inc.)
August 31, 2023
- Reissued Emergency Use Authorization
- Updated Emergency Use Authorization
- Revised Emergency Use Authorization
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- UPDATE: Risk of Device Failures for Getinge’s Maquet/Datascope Cardiosave Intra-Aortic Balloon Pump (IABP) – Letter to Health Care Providers
- Class I Recalls:
- Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for System Over Temperature Alarms Causing Pump Stops
- Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Autofill Failure Alarms Resulting in Pump Stops
- Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Gas Loss and Gas Gain Failures
- Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Power Failures When Device is Unseated from Cart
August 30, 2023
August 29, 2023
- STEM Career Opportunities at CDRH (Updated)
- Reminder: Patient Engagement Advisory Committee (PEAC) Virtual Meeting on Advancing Health Equity in Medical Devices
August 25, 2023
- Medical Device Development Tools (MDDT) (Added Accelerated Testing to Prove Long-Term Material Biostability - Summary of Evidence and Basis of Qualification (SEBQ))
- Medtronic HeartWare Ventricular Assist Device (HVAD) System (Updated)
- Recommendations for Patients and Health Care Providers: HVAD System (Updated)
- Recalls Related to the HVAD System (Updated)
August 24, 2023
- Updated Emergency Use Authorizations
- Revoked Emergency Use Authorizations
August 23, 2023
August 22, 2023
- Medical Device User Fee Amendments 2022 (MDUFA V) (Added "An Introduction to the Medical Device User Fee Program: MDUFA V")
- Mammography Facility Adverse Event and Action Report – August 22, 2023: Phelps Memorial Health Center
August 21, 2023
August 18, 2023
- Meeting materials posted for August 22-23, 2023 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
- CDRH Petitions (updated)
August 17, 2023
- Do Not Use Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation: FDA Safety Communication (Updated)
- Class I Recall: Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for PCBA Failures Affecting the Ability to Charge the Batteries Leading to Unexpected Shutdowns
- Class I Recall: Abiomed Recalls the Labeling for Impella RP Flex with SmartAssist for Risk of Blood Clots
August 16, 2023
August 15, 2023
August 14, 2023
- Global Unique Device Identification Database (GUDID) (Updated)
- Meeting Notice: September 7-8, 2023 Microbiology Devices Panel of the Medical Devices Advisory Committee
- FY 2019-FY 2020 Pediatric Report to Congress
- At-Home OTC COVID-19 Diagnostic Tests (Updated Lucira by Pfizer COVID-19 & Flu Home Test - Shelf Life Extension)
- Class I Recall: Philips Respironics Recalls Trilogy Evo, Evo O2, EV300, and Evo Universal Ventilators After Finding Dust and Dirt in Air Path That Can Reduce Air Flow to Patients
August 11, 2023
- Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- ASCA-Accredited Testing Laboratories (Updated)
- Do Not Use Tests Manufactured by Universal Meditech, Inc.: FDA Safety Communication
- Federal Register: Microbiology Devices Panel of the Medical Devices Advisory Committee
August 10, 2023
- Catalog of Regulatory Science Tools to Help Assess New Medical Devices (Updated)
- CDRH Petitions (Updated)
- Class I Recall: Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Unexpected Shutdowns
- Federal Register: Medical Devices; Reports of Corrections and Removals
August 9, 2023
- Revised Emergency Use Authorization
- Device Registration and Listing (Updated)
- Medical Device User Fee Amendments (MDUFA) (Updated)
- Consumer Information: TOPS System – P220002
August 7, 2023
August 4, 2023
- New Emergency Use Authorization
- Revised Emergency Use Authorizations
- Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 060
August 3, 2023
- Updated Emergency Use Authorizations
- Revoked Emergency Use Authorization
- MedSun Newsletter - August 2023
- CDRH's Experiential Learning Program (ELP) (Updated)
August 1, 2023
- CDRH Learn (Updated)
- Presentation and Transcript for Webinar: Content of Premarket Submissions for Device Software Functions, Final Guidance
- Class I Recall: Baxter Healthcare Corporation Recalls SIGMA Spectrum Infusion Pumps with Master Drug Library and Spectrum IQ Infusion Systems with Dose IQ Safety Software for Repeat Upstream Occlusion False Alarms
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- MQSA National Statistics (Updated)
- Federal Register: Modifications to the List of Recognized Standards, Recognition List Number: 059
July 31, 2023
- Consumer Information: Perclose ProStyle Suture-Mediated Closure and Repair System and Perclose ProGlide Suture-Mediated Closure Systems - P960043/S118
- List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)
- Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration - Letter to Health Care Providers
- Total Product Life Cycle Advisory Program (TAP) (Updated)
July 28, 2023
- GE HealthCare Recalls TruSignal SpO2 Sensors for Issues That May Reduce Defibrillation Energy, Expose Patients to Unintended Voltage, or Give Inaccurate Readings
- Consumer Information: LiquiFix FIX8 and LiquiFix Precision Hernia Mesh Fixation Devices - P220024 (Advanced Medical Solutions, Limited)
- CDRH Petitions (Updated)
July 27, 2023
- Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder - Draft Guidance for Industry and Food and Drug Administration Staff
- Webinar - Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder - Draft Guidance - September 14, 2023
- Class I Recall: Abiomed Recalls All Impella Left Sided Blood Pumps for Risk of Motor Damage After Contact with Transcatheter Aortic Valve Replacement (TAVR) Stent
- Federal Register: Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder
- Federal Register: Medical Devices--Voluntary Improvement Program
- Federal Register: Medical Device User Fee Rates for Fiscal Year 2024
- Federal Register: Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations--Premarket Notification (510(k)) Submissions
July 26, 2023
- Intended Use of Imaging Software for Intracranial Large Vessel Occlusion - Letter to Health Care Providers (Updated)
- Registration and Listing of Medical Devices Relating to COVID-19 (Updated)
- Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff
- Class I Recall: Abbott Recalls Amplatzer Steerable Delivery Sheath for Increased Risk of Air Embolism
- Hydrogen Peroxide Solution (Updated)
July 25, 2023
- Revised Emergency Use Authorization
- Consumer Information: DETOUR Systems - P220021 (Endologix, LLC)
- Consumer Information: FoundationOne Liquid CDx (F1 Liquid CDx) - P190032/S010 (Foundation Medicine, Inc.)
July 24, 2023
- CDRH Announces New Standards Recognition to Support Innovation in Medical Device Sterilization
- Sterilization for Medical Devices (Updated)
July 21, 2023
- New Emergency Use Authorization
- Class I Recall: Megadyne Recalls MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes for Risk of Serious Burn Injuries to Patients (Updated)
July 20, 2023
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- New Emergency Use Authorization
- Revised Emergency Use Authorization
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
July 19, 2023
- Consumer Information: Optilume BPH Catherter System - P220029 (Urotronic, Inc.)
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorization
- Use Alternative Testing Method for the Quidel Cardiovascular Inc. Quidel Triage Cardiac Panel - Letter to Health Care Providers
- CDRH Learn (Updated)
- Device Registration and Listing: An Introduction – Part 1
- Device Registration and Listing: An Introduction – Part 2
- An Introduction to the Medical Device User Fee Program: MDUFA V
July 18, 2023
- Revoked Emergency Use Authorization
- Medtronic Recalls Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with Glassed Feedthrough for Risk of Low or No Energy Output During High Voltage Therapy
- Consumer Information: Eversense E3 Continuous Glucose Monitoring (CGM) System - P160048/S021 (Senseonics, Incorporated)
- CDRH Learn (Updated)
- Printable Slides for Content of Premarket Submissions for Device Software Functions, Final Guidance
- List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)
- At-Home OTC COVID-19 Diagnostic Tests
- Expiration Dates Extended: MaximBio ClearDetect COVID-19 Antigen Home Test
July 17, 2023
- Class I Recall: Quidel Cardiovascular Inc. Recalls Quidel Triage Cardiac Panels for Risk of False Negative Troponin Results that Could Cause Delayed Diagnosis or Missed Myocardial Infarction
- Qualification of Medical Device Development Tools - Guidance for Industry, Tool Developers, and Food and Drug Administration Staff
- Medical Device Development Tools (MDDT) (Updated)
- Medical Device Development Tool (MDDT) Proposal Submission Content (Updated)
- Do Not Use RoyalVibe Health, CellQuicken, or Well-Being Reality Ultrasound Medical Devices: FDA Safety Communication
- Clinical Laboratory Improvement Amendments (CLIA) (Updated)
- CLIA Categorizations (Updated)
- CLIA Waiver by Application (Updated)
July 14, 2023
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated)
- Medical Device Shortages List (Updated)
- Supply and Shortages of Medical Devices: Frequently Asked Questions (Updated)
July 13, 2023
- Surgical Mesh Used for Hernia Repair (Updated)
- Information for Patients (Updated)
- FDA Activities (Updated)
- Reporting Problems to the FDA (Updated)
- CDRH Petitions (Updated)
- U.S.-Japan Regulatory Collaboration (Updated)
- Class I Recalls:
- Consumer Information: Inspire Upper Airway Stimulation - P130008/S090 (Inspire Medical Systems, Inc.)
- Consumer Information: VEGA Steroid-Eluting Endocardial Leads (VEGA R45, VEGA R52, and VEGA R58) - P130010 (MicroPort CRM)
- Federal Register: Charter Amendments, Establishments, Renewals and Terminations: National Mammography Quality Assurance Advisory Committee
July 12, 2023
- Breakthrough Devices Program (Updated)
- Consumer Information: TactiFlex Ablation Catheter, Sensor Enabled - P220013 (Abbott Medical)
July 11, 2023
- MedSun Newsletter - July 2023
- Class I Recall: Megadyne Recalls MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes for Risk of Serious Burn Injuries to Patients
- UPDATE: Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease Unlikely to Increase Risk of Mortality - Letter to Health Care Providers
- Paclitaxel-Coated Balloons and Stents for Peripheral Arterial Disease (Updated)
July 10, 2023
- Revised Emergency Use Authorization
- Consumer Information:
- SKINVIVE by JUVÉDERM – P110033/S059 (Allergan Aesthetics)
- Restylane Eyelight – P040024/S135 (Galderma Laboratories, L.P.)
- Electronic Export Documents – Letter to Industry
- CDRH Petitions (Updated)
July 7, 2023
- Revised Emergency Use Authorization
July 6, 2023
- Revised Emergency Use Authorization
- Updated Emergency Use Authorizations
- Dermal Fillers (Soft Tissue Fillers) (Updated)
- Automated External Defibrillators (AEDs) (Updated)
July 5, 2023
- Updated Emergency Use Authorization
- OHC COVID-19 Antigen Self Test (Osang, LLC.)
- SPERA COVID-19 Ag Test (Xtrava Health)
- Revoked Emergency Use Authorization
- CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3) (Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard)
- MQSA National Statistics (Updated)
July 3, 2023
- New Emergency Use Authorization
- Revised Emergency Use Authorization
- At-Home OTC COVID-19 Diagnostic Tests
- iHealth COVID-19 Antigen Rapid Test (iHealth Labs, Inc.)
- Status COVID-19 Antigen Rapid Test for Home Use (Princeton BioMeditech Corp.)
- Updated Emergency Use Authorization