CDRHNew - News and Updates
A comprehensive list of the latest CDRH updates.
This Week in CDRH
December 27, 2023
December 22, 2023
- Consumer Information: RHA 3 dermal filler - P170002/S030 (Teoxane SA)
December 21, 2023
- Medical Device Coverage Initiatives: Connecting with Payors via the Payor Communication Task Force (Updated)
- Network of Experts Program: Connecting the FDA with External Expertise (Updated)
- 2024 OSEL Summer Research Program (Updated)
- COVID-19 Tests Granted Traditional Marketing Authorization by the FDA (Updated)
- Xpert® Xpress CoV-2 plus (Cephid)
December 20, 2023
- 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations
- Federal Register: 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability
- Class I Recall: Philips North America LLC Recalls Panorama 1.0T HFO due to a Risk of Explosion During a Quench Procedure Caused by Excessive Pressure Buildup of Helium Gas
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- Pilot COVID-19 At-Home Test (SD Biosensor, Inc.) - Extended Expiration Dates
December 19, 2023
- CDRH Statement: FDA Approves First Test to Help Identify Elevated Risk of Developing Opioid Use Disorder
- Class I Recalls:
- Becton Dickinson (BD)/Carefusion 303 Recalls Alaris Infusion Pumps Due to Compatibility Issues with Cardinal Health Monoject Syringes (Updated)
- Olympus Corporation of the Americas Recalls Bronchofiberscopes and Bronchovideoscopes Because They Can Lead to Burns and Fire
- Medtronic Navigation Inc. Recalls StealthStation S8 Application Version 2.0 and 2.0.1 Due to a Software Glitch
- Summary Minutes: November 7, 2023 Radiological Devices Panel of the Medical Devices Advisory Committee Meeting
December 18, 2023
- Federal Register: Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- CDRH Learn (Updated)
- Send and Track Medical Device Premarket Submissions Online: CDRH Portal (Updated)
- Total Product Life Cycle Advisory Program (TAP) (Updated)
- Recognized Consensus Standards Database (Updated)
December 15, 2023
- Breast Implants (Updated)
- Risks and Complications of Breast Implants (Updated)
- Labeling for Approved 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 Implant Postmarket Safety Information (Updated)
December 14, 2023
- New Emergency Use Authorizations
- Revised Emergency Use Authorization
- How to Prepare a Traditional 510(k) (Updated)
December 12, 2023
- Webinar - Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program - 12/12/23 (Printable Slides added)
- CDRH Learn - Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program (New Module 12/11/23)
December 8, 2023
- Class I Recall: Getinge Recalls CARDIOHELP Emergency Drive due to an Impaired or Inability to Turn the Drive
- MedSun Newsletter - December 2023
December 7, 2023
December 6, 2023
- eSTAR Program (Updated)
December 5, 2023
- Class I Recall: Cordis US Corp Recalls INFINITI Angiographic Catheter due to Products Being Shipped Without Undergoing Sterilization Procedures
December 4, 2023
- Transcript for November 7, 2023 Radiological Devices Panel of the Medical Devices Advisory Committee Meeting
- 24 Hour Summary and Presentations for November 29, 2023 Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting
- Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication (Updated)
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Devices; Device Tracking
December 1, 2023
- Class I Recall: Eitan Medical Ltd Recalls Sapphire Infusion Pumps for Failure to Detect Air in the Line
- MQSA National Statistics (Updated)
- Total Product Life Cycle Advisory Program (TAP) (Updated)
- Class I Recall: Becton Dickinson (BD)/Carefusion 303 Recalls Alaris Infusion Pumps Due to Compatibility Issues with Cardinal Health Monoject Syringes
November 30, 2023
- FDA Safety Communication: Evaluating Plastic Syringes Made in China for Potential Device Failures
November 29, 2023
- Antimicrobial Resistance Information from FDA (Updated)
- Federal Register: Effective Date of Requirement for Premarket Approval Applications for Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Cream, or Ointment; and Liquid Wound Washes Containing Medically Important Antimicrobials
- Federal Register: Classification of Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes
- Left Atrial Appendage Occlusion (LAAO) Devices Potentially Associated with Procedural Outcome Differences Between Women and Men – Letter to Health Care Providers (Updated)
- ASCA-Accredited Testing Laboratories (Updated)
November 28, 2023
- Updated Emergency Use Authorization
- Medical Device Single Audit Program (MDSAP) (Updated)
- Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety Communication
November 27, 2023
- The FDA Withdraws as a Member of the Global Harmonization Working Party
- Class I Recall: Unomedical A/S Recalls VariSoft Infusion Sets Due to Damage to the Connector Piece Causing Unexpected Disconnections
- Webinar - Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program - 12/12/2023
- Materials for November 29, 2023 Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Shortages Data Collections
November 21, 2023
- Current Career Opportunities at CDRH (Updated)
- ASCA-Accredited Testing Laboratories (Updated)
November 20, 2023
- Letter to Health Care Providers: Do Not Use Cardinal Health Monoject Syringes with Syringe Pumps and PCA Pumps
- At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated)
- CDRH Learn (Updated)
- Presentation and Transcript for Webinar: Breakthrough Devices Program Updated Final Guidance, November 14, 2023
- Scientific Research Jobs, Fellowships, and Collaborations on Medical Devices (Updated)
- FDA Safety Communication: Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories
November 17, 2023
- Meeting Notice: February 2, 2024: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee
- Meeting Notice: February 6, 2024 General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee
- Class I Recall: B. Braun Medical, Inc. Recalls Infusomat Space Large Volume Pump, Wireless and Infusomat Space Large Volume Pump, Non-Wireless BATTERY PACK Due to Faulty Occlusion Alarm
- MedSun Newsletter - November 2023
November 16, 2023
- New Emergency Use Authorization
- Updated Emergency Use Authorization
- MDUFA Reports (Updated)
- Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act - Guidance for Industry and Food and Drug Administration Staff
- Select Updates for the 506J Guidance: 506J Device List and Additional Notifications - Draft Guidance for Industry and Food and Drug Administration Staff
- Supply and Shortages of Medical Devices: Frequently Asked Questions (Updated)
- Medical Device Supply Chain and Shortages (Updated)
- 506J Device List
- Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff
- Credibility of Computational Models Program: Research on Computational Models and Simulation Associated with Medical Devices (Updated)
- Webinar - Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Final Guidance - January 11, 2024
- CDRH Petitions (Updated)
- Artificial Intelligence Program: Research on AI/ML-Based Medical Devices (Updated)
- CDRH Statement: CDRH Takes Steps to Advance Further Discussions on Pulse Oximeters
- Pulse Oximeters
- Pulse Oximeter Accuracy and Limitations: FDA Safety Communication (Updated)
- Class I Recall: Asensus Surgical Inc. Recalls Senhance Surgical System Due to Malfunctions with Unintended Movement of the Robotically-Assisted Surgical Device
- Federal Register: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee, Pulse Oximeters
- Federal Register: General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee
- Federal Register: Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device under the Federal Food, Drug, and Cosmetic Act and Select Updates
- Federal Register: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions
- Federal Register: Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220087, DEN220090, DEN220091 and DEN230002 added)
November 15, 2023
- Collaborative Communities: Addressing Health Care Challenges Together (Updated)
- CDRH Petitions (Updated)
- 24 Hour Summary and Presentations for November 7, 2023 Radiological Devices Panel of the Medical Devices Advisory Committee Meeting
- Cybersecurity (Updated)
- Class I Recall: Baxter Healthcare Corporation Recalls Novum IQ Syringe Pump for Potential Underdosing
- Class I Recall: Fresenius Medical Care Recalls Sanxin Single Use Syringes for Leakages
November 14, 2023
- Meeting Notice: November 29, 2023 Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee
- Total Product Life Cycle Advisory Program (TAP) (Updated)
- Class I Recall: Cardinal Health Recalls Monoject Disposable Syringes for Incompatibilities with Syringe Pumps
November 13, 2023
- Class I Recall: Covidien LLC Recalls McGRATH MAC Video Laryngoscope Due to Stolen Defective Products
November 10, 2023
November 9, 2023
November 8, 2023
- Withdrawn or Expired Guidance (Updated)
- Coronavirus (COVID-19) and Medical Devices (Updated)
- Emergency Use Authorizations for Medical Devices (Updated)
- FAQs on Testing for SARS-CoV-2 (Updated)
- Importing Medical Devices Relating to COVID-19 (Updated)
- Ventilators and Ventilator Accessories EUAs (Updated)
- Ventilators and Ventilator Accessories for COVID-19 (Updated)
- FAQs on Viral Transport Media During COVID-19 (Updated)
- Registration and Listing of Medical Devices Relating to COVID-19 (Updated)
- Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19 (Updated)
- Contacts for Medical Devices Related to COVID-19 (Updated)
- Federal Register: Hematology and Pathology Devices; Classification of the Container System for the Processing and Storage of Red Blood Cell Components Under Reduced Oxygen Conditions
November 7, 2023
November 6, 2023
- Recognized Consensus Standards: Medical Devices
- Class I Recall: Teleflex, and Arrow International, Recall Pressure Injectable Catheter Kits for Mislabeling
- Do Not Use Certain Brands of Saline and Sterile Water Medical Products by Nurse Assist Because They May Not Be Sterile: FDA Safety Communication
November 3, 2023
- Consumer Information: Boston Scientific Cardiac Cryoablation System - P220032 (Boston Scientific Corporation)
- Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices - Guidance for Industry and Food and Drug Administration Staff
- CDRH Learn (Updated)
- Transcript for Webinar: CDRH's New Draft Guidances to Continue to Modernize the 510(k) Program - October 26, 2023
- Meeting materials for November 7, 2023 Radiological Devices Panel of the Medical Devices Advisory Committee
- Transcript and Summary Minutes for September 7-8, 2023 Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting
- Medical Device Single Audit Program (MDSAP) (Updated)
- Federal Commission for Protection from Sanitary Risks (COFEPRIS) of Mexico (NEW)
November 2, 2023
- Enforcement Policy for Clinical Electronic Thermometers - Guidance for Industry and Food and Drug Administration Staff
- Non-contact Infrared Thermometers (Updated)
- MQSA National Statistics (Updated)
- Consumer Information: LimFlowTM System - P220025 (LimFlow, Inc.)
- Federal Register: Enforcement Policy for Clinical Electronic Thermometers
- Federal Register: Exemptions from Premarket Notification: Class II Devices; Clinical Electronic Thermometers
- CDRH seeks public comment: Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes
November 1, 2023
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- MaximBio ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.) - Extended Expiration Dates
- Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions - Guidance for Industry and Food and Drug Administration Staff
- Webinar - Immediately-in-effect guidance: Antimicrobial Susceptibility Test System Devices - Updating Breakpoints in Device Labeling - December 5, 2023 (Date Changed)
- Federal Register: Enforcement Policy for Certain Supplements for Approved Premarket Approval or Humanitarian Device Exemption Submissions
- Federal Register: Charter Amendments, Establishments, Renewals and Terminations: Patient Engagement Advisory Committee
October 31, 2023
- Updated Emergency Use Authorizations
- CDRH Petitions (updated)
- Explore Life at CDRH
- Federal Register: Requests for Nominations: Public Advisory Panels of the Medical Devices Advisory Committee
October 30, 2023
- FDA Activities Related to Essure (Updated)
- Information for Patients and Health Care Providers: Essure (Updated)
- Laboratory Developed Tests (Updated)
- Class I Recall: Olympus Recalls Olympus High Flow Insufflation Unit Due to Over-Inflation
October 27, 2023
- Revised Emergency Use Authorization
October 24, 2023
- Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
- CDRH Issues Guiding Principles for Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices
- CDRH Learn (Updated)
- Presentation and Transcript for 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
- Class I Recall: Fresenius Medical Care Recalls Some Hemodialysis Machines for Potential Exposure to Toxic Compounds
October 23, 2023
- CDRH Trade Press Contact Information
- About Manufacturer and User Facility Device Experience (MAUDE) (Updated)
October 20, 2023
- Class I Recall: Philips Respironics Recalls V60 and V60 Plus Ventilators due to Power Management Printed Circuit Board Assemblies (PM PCBAs) Not Meeting Ventilator Standards
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210011, DEN210056, DEN220023, DEN220026, DEN220052, DEN220073,
DEN230006, DEN230007, DEN230019, and DEN230021 added)
October 19, 2023
- Medical Device Shortages List (Updated)
- Consumer Information: PALMAZ MULLINS XD Pulmonary Stent - P220004 (Cordis US Corp.)
- Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices (Updated)
October 18, 2023
- Class I Recall: Hamilton Medical Inc. Recalls HAMILTON-C1, T1, MR-1 Ventilators for Capacitator Leaks and Short Circuits
- Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring - Guidance for Industry and Food and Drug Administration Staff
- Do Not Use Tests Manufactured by Universal Meditech, Inc.: FDA Safety Communication (Updated)
- Total Product Life Cycle Advisory Program (TAP) (Updated)
October 17, 2023
October 16, 2023
- New Emergency Use Authorization
- Evaluation of Airborne Chemicals from Neonatal Incubators - Letter to Health Care Providers (Updated)
- Webinar - Proposed Rule: Medical Devices; Laboratory Developed Tests - 10/31/2023
October 13, 2023
- Consumer Information: CRCdx(R) RAS Mutation Detection Kit - P220005 (EntroGen, Inc.)
October 12, 2023
- Updated Emergency Use Authorization
- Public Webinar – Breakthrough Devices Program Updated Final Guidance – November 14, 2023
- Center for Devices and Radiological Health (CDRH) Compliance Programs (Updated)
October 11, 2023
- Digital Health Advisory Committee
- MedSun Newsletter - October 2023
- Federal Register: Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health
- Federal Register: Requests for Nominations: Individuals and Consumer Organizations for the Digital Health Advisory Committee
- Federal Register: Requests for Nominations: Individuals and Industry Organizations for the Digital Health Advisory Committee
- Federal Register: Requests for Nominations: Voting Members for the Digital Health Advisory Committee
October 10, 2023
- Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff
- Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff
- CDRH Proposed Guidances for Fiscal Year 2024 (FY2024)
- CDRH Proposed Guidance Development
October 6, 2023
- Revoked Emergency Use Authorization
- List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)
- Federal Register: Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of Mpox
October 5, 2023
- CDRH Provides Update on Philips June 2021 Recall and Maintains Recommendations Related to Potential Health Risks of PE-PUR Foam
- Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
- Third Party Performance Report - FY23, Q4
October 4, 2023
- Virtual Public Workshop – Extended Reality in Orthopedic Surgical Devices: Insights into User Experience and Adverse Event Reporting for Patient Safety - November 2, 2023
- Medical Devices Cybersecurity: Infographic
- MQSA National Statistics (Updated)
- CDRH Statement: CDRH Recognizes 10-Year Anniversary of Cybersecurity Program and Continued Steps to Help Ensure Medical Device Cybersecurity
- Federal Register: Emergency Use Authorization: In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19
- Federal Register: Meetings: Radiological Devices Panel of the Medical Devices Advisory Committee
October 3, 2023
- At-Home OTC COVID-19 Diagnostic Tests - Shelf Life Extended
- Catalog of Regulatory Science Tools to Help Assess New Medical Devices (Updated)
- Federal Register: Revocation of Authorization of Emergency Use: Becton, Dickinson and Company Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site)
October 2, 2023
- Revised Emergency Use Authorizations
- Electronic Submission Template for Medical Device 510(k) Submissions - Guidance for Industry and Food and Drug Administration Staff
- eSTAR Program (Updated)
- CDRH Statement: CDRH Provides Update on the Total Product Life Cycle Advisory Program Pilot
- Total Product Life Cycle Advisory Program (TAP) (Updated)
September 29, 2023
- New Emergency Use Authorizations
- Revised Emergency Use Authorizations
- 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.)
- MaximBio ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.)
- OHC COVID-19 Antigen Self Test (OSANG LLC)
- Revoked Emergency Use Authorization
- Laboratory Developed Tests (Updated)
- Recommendations for Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2 (Updated)
- Federal Register: Medical Devices: Laboratory Developed Tests
September 28, 2023
- Updated Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Electronic Submission Template for Medical Device De Novo Requests - Draft Guidance for Industry and Food and Drug Administration Staff
- SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests
- Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling - Guidance for Industry and Food and Drug Administration Staff
- Webinar – Immediately-in-effect guidance: Antimicrobial Susceptibility Test System Devices – Updating Breakpoints in Device Labeling
- COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
- Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology - Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Antimicrobial Susceptibility Test System Devices--Updating Breakpoints in Device Labeling
- Federal Register: Electronic Submission Template for Medical Device De Novo Requests
- Federal Register: Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology
September 27, 2023
- Personal Protective Equipment EUAs (Updated)
September, 26, 2023
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff
- Cybersecurity (Updated)
- Cybersecurity in Medical Devices Frequently Asked Questions (FAQs) (Updated)
- Webinar - Final Guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - November 2, 2023
- Federal Register: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
September 22, 2023
- New Emergency Use Authorization
- Consumer Information on: AAV5 DetectCDx – P190033 (ARUP Laboratories)
- CDRH Recruitment Calendar
September 21, 2023
- Revised Emergency Use Authorizations
- At-Home OTC COVID-19 Diagnostic Tests (Updated Lucira by Pfizer COVID-19 & Flu Home Test)
September 20, 2023
- Class I Recall: Medline Industries Recalls Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Due to Being Non-Sterile
- Catalog of Regulatory Science Tools to Help Assess New Medical Devices (Updated)
September 19, 2023
- CDRH Statement: CDRH Announces International Harmonization Strategic Plan
- CDRH International Affairs (Updated)
- CDRH Learn (Updated)
- Presentation and Transcript for Webinar: Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder: Draft Guidance
- Presentation and Transcript for Webinar: Qualification of Medical Device Development Tools: Final Guidance
- Standards and Conformity Assessment Program (Updated)
- Accreditation Scheme for Conformity Assessment (ASCA) (Updated)
- Accreditation Bodies: How to Participate in ASCA (Updated)
- Manufacturers: How to Participate in ASCA (Updated)
- ASCA-Accredited Testing Laboratories (Updated)
- ASCA-Recognized Accreditation Bodies (Updated)
- Testing Laboratories: How to Participate in ASCA (Updated)
- How to Study and Market Your Device (Updated)
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.)