CDRHNew - News and Updates
A comprehensive list of the latest CDRH updates.
This Week in CDRH
April 17, 2024
- CDRH Statement: CDRH Issues 2024 Safety and Innovation Reports
- Medical Device Safety and Innovation Reports (Updated)
- Current Career Opportunities at CDRH (Updated)
- Class I Recall: Boston Scientific Recalls Obsidio Conformable Embolic for Increased Bowel Ischemia Risk When Used for Lower GI Bleeding
- Class I Recall: Fresenius Kabi USA, LLC Recalls Ivenix Infusion Pump LVP Software for Anomalies That Have the Potential to Cause Serious Patient Harm or Death
April 16, 2024
- CDRH Unveils New Dataset to Help Improve Chemical Characterization Methods for Biocompatibility of Medical Devices
- Manufacturer and User Facility Device Experience (MAUDE) (Updated)
- CDRH Petitions (Updated)
April 15, 2024
- Revised Emergency Use Authorization
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- Class I Recall: Abbott/Thoratec Corp. Recalls HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to Long-term Buildup Causing an Obstruction
- Medical Device Sterilization Town Hall: Topics and Formats for the Continuing Sterilization Series, April 29, 2024
- Sterilization for Medical Devices (Updated)
April 11, 2024
- MedSun Newsletter - April 2024
- Stress Urinary Incontinence: Surgical Mesh Considerations and Recommendations (Updated)
April 10, 2024
- New Emergency Use Authorization
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- FDA Activities Related to Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines (Updated)
- Foam Testing Summary for Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines (Updated)
- UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication (Updated)
- COVID-19 Tests Granted Traditional Marketing Authorization by the FDA (Updated)
- ASCA-Accredited Testing Laboratories (Updated)
April 9, 2024
- Problems Reported With Essure (Updated)
- Information for Patients and Health Care Providers: Essure (Updated)
- FDA Activities Related to Essure (Updated)
April 8, 2024
- New Emergency Use Authorization
- Re-issued Emergency Use Authorizations
April 4, 2024
- New Emergency Use Authorization
- ASCA-Accredited Testing Laboratories (Updated)
- Class I Recall: Smiths Medical ASD Recalls PneuPac ParaPAC Plus 300 and 310 Ventilator Kits for a Malfunction Causing Non-Cycling, Continuous Positive Gas Flow and Preventing Proper Ventilation
- Class I Recall: Medos International Sàrl Recalls Cerenovus CEREBASE DA Guide Sheath due to Cracking of the Distal Catheter Shaft
- Federal Register: Device Good Manufacturing Practice Advisory Committee
- Federal Register: Voting Members for the Patient Engagement Advisory Committee
April 3, 2024
- UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication (Updated)
- Class I Recall: Teleflex and Arrow International Recall ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits for Increased Resistance That May Lead to Vessel Injuries, Narrowing, or Blockage
- Reports to Congress (Updated)
- FY 2021 Premarket Approval of Pediatric Uses of Devices
- Medical Device Development Tools (MDDT) (Updated)
April 2, 2024
- Current Career Opportunities at CDRH (Updated)
- Evaluation of Automatic Class III Designation (De Novo) Summaries - Sleep Apnea Feature - DEN230041
April 1, 2024
- CDRH Learn (Updated)
- Presentation and Transcript for Medical Device Sterilization Town Hall: The Value and Use of Recognized Consensus Standards in Premarket Submissions - March 21, 2024
- Standards Newsletter from the Division of Standards and Conformity Assessment
- MQSA National Statistics (Updated)
March 29, 2024
- eSTAR Program (Updated)
March 28, 2024
- Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff
- Co-sponsored Public Meeting - Food and Drug Administration/Medical Device Innovation Consortium Symposium on Computational Modeling and Simulation - April 16-17, 2024
- Mammography Quality Standards Act and Program (Updated)
- Mammography Quality Standards Act - Facility Accreditation and Certification (Updated)
- Mammography Quality Standards Act - Inspection Resources
- Federal Register: Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions
March 27, 2024
- ASCA Consolidated Pilot Final Report and 2023 Annual Report
- Evaluation of Automatic Class III Designation (De Novo) Summaries - Invitae Common Hereditary Cancers Panel (DEN210011)
March 26, 2024
- New Emergency Use Authorizations
- Evaluation of Automatic Class III Designation (De Novo) Summaries - Body Temperature Software (BTS) (DEN230050), Sonu (DEN230045), X100 with Full Field Bone Marrow Aspirate (BMA) Application, X100HT with Full Field Bone Marrow Aspirate (BMA) Application (DEN230034)
- Total Product Life Cycle Advisory Program (TAP) (Updated)
March 25, 2024
- CDRH Statement: FDA Proposes New Ban of Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
- Medical Device Bans (Updated)
- Class I Recall: Medline Industries Recalls Certain Kits and Trays Containing Sterile Water Based Products Under Recall by Nurse Assist
- 24 Hour Summary and Presentations for March 21, 2024 Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting
- Federal Register: Banned Devices: Proposal to Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
March 21, 2024
- Class I Recall: Abiomed Recalls the Instructions for Use for Impella Left Sided Blood Pumps due to Perforation Risks
- Class I Recall: Vyaire Medical, Inc. Recalls AirLife Manual Resuscitators Due to Manufacturing Defect That Can Lead to Injury or Death
- Breakthrough Devices Program (Updated)
March 20, 2024
- New Emergency Use Authorization
- Transcript and Summary Minutes for February 13, 2024 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
- Federal Register: Emergency Use Authorization: In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Revocation
- Federal Register: Voluntary Total Product Life Cycle Advisory Program Pilot
March 19, 2024
- CDRH Statement: FDA Provides Update on Plastic Syringes Made in China, Issues Warning Letters Related to Violative Products
- UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication
- Materials for March 21, 2024 Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting
March 18, 2024
March 15, 2024
- Artificial Intelligence and Machine Learning in Software as a Medical Device (Updated)
- Consumer Information: Belotero Balance® (+) - P090016/S050 (Merz North America, Inc.)
March 14, 2024
- Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling - Guidance for Industry and Food and Drug Administration Staff
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Draft Guidance for Industry and Food and Drug Administration Staff
- Medical Device Sterilization Town Hall: The Value and Use of Recognized Consensus Standards in Premarket Submissions - March 21, 2024
- Sterilization for Medical Devices (Updated)
- Class I Recall: Avanos Recalls MIC Gastric – Jejunal Feeding Tube Kits Containing Sterile Water Based Products Under Recall by Nurse Assist
- Federal Register: Medical Devices; Technical Amendments
- Federal Register: Evaluation of Thermal Effects of Medical Devices That Produce Tissue Heating and/or Cooling
- Federal Register: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
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
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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