CDRHNew - News and Updates
A comprehensive list of the latest CDRH updates.
This Week in CDRH
May 23, 2024
- UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication (Updated)
- Co-sponsored Public Workshop - Using Patient-Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Lifecycle - June 26-27, 2024
May 22, 2024
- Consumer Information: TZ Medical Adult and Pediatric Multi-Function Defibrillation Electrodes and Adaptors - P200005 (TZ Medical, Inc.)
- Class I Recall: Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices
- ASCA-Accredited Testing Laboratories (Updated)
- Consumer Information: Duo Venous Stent System - P230021 (Vesper Medical, Inc.)
May 21, 2024
- Consumer Information: restor3d Total Talus Replacement - H230003 (restor3d, Inc.)
- Materials for May 23, 2024 Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting
- UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication (Updated)
- Influenza Diagnostic Tests
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation B12 Pediatric Device Survey
May 20, 2024
- CDRH Learn (Updated)
- Presentation and Transcript for Webinar - Final Rule: Medical Devices; Laboratory Developed Tests - May 14, 2024
May 17, 2024
May 16, 2024
- Revised Emergency Use Authorization
- Qualification of New Medical Device Development Tools (MDDT)
- UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication (Updated)
- Federal Register: Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
May 15, 2024
- Webinar - Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances - June 5, 2024
- Class I Recall: Abbott Recalls HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit for Risk of Blood Leakage or Air Entering System Between Inflow Cannula and Apical Cuff
- Class I Recall: Draeger, Inc. Recalls Perseus A500 Anesthesia System for Risk of Sudden Unexpected Shutdown When Used on Battery Power (Updated)
- Federal Register: Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
May 14, 2024
- Laboratory Developed Tests (Updated)
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
May 13, 2024
- Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices (Updated)
- Class I Recall: Philips Respironics, Inc. Recalls Trilogy Evo Continuous Ventilators due to a Software-Related Possible Power Malfunction
- Medical Device Sterilization Town Hall: Sterilization Method Selection for New and Existing Devices - 05/23/2024
- Sterilization for Medical Devices (Updated)
- Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication
May 10, 2024
- New Emergency Use Authorization
- Updated Emergency Use Authorization
- Class I Recall: Route 92 Medical Inc. Recalls Catheter due to Distal Tip Separation at the Proximal Marker Band
May 9, 2024
- UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication (Updated)
- Remanufacturing of Medical Devices - Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff
- Webinar: Final Guidance: Remanufacturing of Medical Devices - 06/27/2024
- Remanufacturing and Servicing Medical Devices (Updated)
- Tips to Help Charge Medical Devices Safely and Avoid Overheating
- CDRH Learn (Updated)
- Presentation and Transcript for Medical Device Sterilization Town Hall: Topics and Formats for the Continuing Town Hall Series - April 29, 2024
- Presentation and Transcript for Draft Guidance: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act - April 30, 2024
- Federal Register: Remanufacturing of Medical Devices; Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff; Availability
May 8, 2024
- Why Choose CDRH for Your Career? (Updated)
- Explore Life at CDRH (Updated)
- Class I Recall: Tandem Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ Technology Prompted by a Software Problem Leading to Pump Battery Depletion
- Safety and Quality Concerns with Getinge Cardiovascular Devices - Letter to Health Care Providers
- MedSun Newsletter - May 2024
May 7, 2024
- New Emergency Use Authorization
- Revised Emergency Use Authorization
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- CDRH Petitions (Updated)
May 6, 2024
May 3, 2024
- Consumer Information: XACT Carotid Stent System - P040038/S043 (Abbott Vascular Inc.)
May 2, 2024
- 2024 Regulatory Education for Industry (REdI) Conference
- Consumer Information: Paradise Ultrasound Renal Denervation System - P220023 (Recor Medical, Inc.)
May 1, 2024
- Revoked Emergency Use Authorization
- Consumer Information: FoundationOne CDx Liquid (F1 Liquid CDx) - P190032/S011 (Foundation Medicine, Inc.)
- List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)
- Qualification of New Medical Device Development Tools (MDDT)
April 30, 2024
- Class I Recall: BioMérieux Inc. Recalls VITEK 2 AST Kit due to Incorrect Ceftriaxone Concentrations
- Collaborative Communities: Addressing Health Care Challenges Together (Updated)
- Federal Register: Laboratory Developed Tests
- Federal Register: Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564
April 29, 2024
- Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564 - Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff
- Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency - Draft Guidance for Industry and Food and Drug Administration Staff
- Webinar - Final Rule: Medical Devices; Laboratory Developed Tests - May 14, 2024
- Laboratory Developed Tests: Frequently Asked Questions
- Laboratory Developed Tests (Updated)
- Class I Recall: SonarMed Inc. Recalls Airway Acoustic Sensors Due to a Restricted Inner Diameter of Airway Causing Suction Catheter Passage Difficulty
- Class I Recall: SonarMed Inc. Recalls Airway Monitors Due to a Software Anomaly Resulting in Failure to Detect a Partial Obstruction in 2.5mm Sensors and Up To 3mm Distal to the Sensor Tip
- Federal Register: Laboratory Developed Tests
- Federal Register: Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564
- Federal Register: Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency
April 27, 2024
- Current Career Opportunities at CDRH (Updated)
April 26, 2024
- Medical Device Shortages List (Updated)
- Class I Recall: Elekta Instrument AB Recalls Disposable Biopsy Needle Kit for Leksell Stereotactic System for Possibly Containing Microscopic Stainless Steel Debris on the Inside of the Biopsy Needle
- Printable Slides for: Webinar - Draft Guidance: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act
April 25, 2024
- Class I Recall: Fresenius Medical Care Recalls Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA
- Class I Recall: Outset Medical, Inc. Recalls Certain Tablo Hemodialysis Systems for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBAs
- Class I Recall: Draeger, Inc. Recalls Perseus A500 Anesthesia System for Risk of Sudden Unexpected Shutdown When Used on Battery Power
- Class I Recall: InfuTronix, LLC Recalls Nimbus and Nimbus II Infusion Pump Systems for Multiple Device Failures That May Cause Severe Injury and Death
- UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication
- COVID-19 Tests Granted Traditional Marketing Authorization by the FDA (Updated)
- Printable Slides: Medical Device Sterilization Town Hall: Topics and Formats for the Continuing Sterilization Series - 04/29/2024
April 24, 2024
- Class I Recall: DeRoyal Industries, Inc. Recalls Tracecarts Containing 16FR Urine Meter Foley Under Recall by Nurse Assist
- Transcript and Summary Minutes for March 21, 2024: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 03/21/2024
- Meeting Notice: May 23, 2024 Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee
April 23, 2024
- New Emergency Use Authorization
- CDRH Statement: FDA Launches Health Care at Home Initiative to Help Advance Health Equity
April 22, 2024
- FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety Communication
- Federal Register: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee, Guardant Shield Blood Collection Kit
April 19, 2024
- Updated Emergency Use Authorization
- Revoked Emergency Use Authorization
- Risks with Exactech Equinoxe Shoulder System with Defective Packaging - FDA Safety Communication (Updated)
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)