CDRHNew - News and Updates
A comprehensive list of the latest CDRH updates.
This Week in CDRH
June 10, 2024
June 7, 2024
June 6, 2024
June 5, 2024
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated)
- Class I Recall: Medtronic Recalls StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 for Software Error that May Cause Incorrect Measurements During Cranial Surgery
June 4, 2024
- Revised Emergency Use Authorizations
- Consumer Information: TheraBionic P1 - H220001 (TheraBionic, Inc.)
- 510(k) Third Party Performance Metrics and Accreditation Status (Updated)
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Device Recall Authority
June 3, 2024
May 31, 2024
May 30, 2024
- New Emergency Use Authorizations
- Class I Recall: OptumHealth Care Solutions Recalls Nimbus II Infusion Pump Systems Under Recall by InfuTronix, LLC
- Mammography Facility Inspection Fees (Updated)
- Consumer Information: Abbott Spinal Cord Stimulation (SCS) Systems - P010032/S191 (Abbott Medical)
May 29, 2024
- Total Product Life Cycle Advisory Program (TAP) (Updated)
- CDRH Petitions (Updated)
- Medical Device Sterilization Town Hall: Sterilization Open Q&A - 06/12/2024
- Sterilization for Medical Devices (Updated)
- Consumer Information: Xstim Spine Fusion Stimulator - P230025 (Xstim Inc.)
May 28, 2024
- Updated Emergency Use Authorizations
- Revoked Emergency Use Authorizations
- Federal Register: Agency Information Collection Activities Proposals, Submissions, and Approvals: De Novo Classification Process (Evaluation of Automatic Class III Designation)
May 24, 2024
- Consumer Information: Spectra WaveWriter, WaveWriter Alpha and Alpha Prime Spinal Cord Stimulation Systems - P030017/S363 (Boston Scientific Corp.)
- Revised Emergency Use Authorization
- Updated Emergency Use Authorization
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
- Standard Operating Procedure (SOP) for Resolution of Internal Differences of Opinion in Regulatory Decision-Making (Updated)
- Class I Recall:
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Vyaire Medical, Inc. Recalls the Twin Tube Due to The Potential of The Nozzle Separating During Patient Use
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)