CDRHNew - News and Updates
A comprehensive list of the latest CDRH updates.
This Week in CDRH
February 15, 2024
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
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
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- 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)
- 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
- CDRH's Experiential Learning Program (ELP) (Updated)
- COVID-19 Tests Granted Traditional Marketing Authorization by the FDA (Updated)
- 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
- 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
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)
- 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)
- 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)
- Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee
January 18, 2024
- FDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made
- CDRH Learn (Updated)
- 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
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
January 10, 2024
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
January 8, 2024
- Revised Emergency Use Authorization
- 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
January 4, 2024
-
ASCA-Accredited Testing Laboratories (Updated)
January 3, 2024
- Updated Emergency Use Authorizations
- Evaluation of Airborne Chemicals from Neonatal Incubators - Letter to Health Care Providers (Updated)
- Do Not Use Synovo Total Hip Resurfacing System: FDA Safety Communication
January 2, 2024
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