CDRHNew - News and Updates
A comprehensive list of the latest CDRH updates.
This Week in CDRH
March 13, 2024
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- Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act - Draft Guidance for Industry and Food and Drug Administration Staff
- Webinar - Draft Guidance: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act - April 30, 2024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
- 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
- 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
February 26, 2024
- Updated Emergency Use Authorization
- 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
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
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