CDRHNew - News and Updates
A comprehensive list of the latest CDRH updates.
January 17, 2025
- Revised Emergency Use Authorization
- At-Home OTC COVID-19 Diagnostic Tests
- CDRH 2024 Annual Report
- MedSun Newsletter - January 2025
January 16, 2025
- Update: Evaluation of Airborne Chemicals from Neonatal Incubators - Letter to Health Care Providers
- Early Alert: Infusion Pump Software Issue from Fresenius Kabi USA
January 15, 2025
- Definitions and General Oversight: Laboratory Developed Tests FAQs (Updated)
- Phaseout Policy and Enforcement Discretion Policies: Laboratory Developed Tests FAQs (Updated)
- Medical Device Reporting, Complaints, and Corrections & Removals Reporting: Laboratory Developed Tests FAQs (Updated)
- Class I Recall: Endoscopic Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular Update Use Instructions for VasoView HemoPro 2 (VH-4000 and VH-4001) EVH Systems due to Risk for Bent or Detached Heater Wires and Silicone Peeling or Detaching During Use
- Total Product Life Cycle Advisory Program (TAP) (Updated)
- Accreditation Scheme for Conformity Assessment (ASCA) (Updated)
January 14, 2025
- Recognized Consensus Standards Database (Updated)
January 13, 2025
- Revoked Emergency Use Authorizations
- Access SARS-CoV-2 IgG (Beckman Coulter, Inc.)
- Access SARS-CoV-2 IgM (Beckman Coulter, Inc.)
- Access SARS-CoV-2 IgG II (Beckman Coulter, Inc.)
- De Novo Decision Summary:
- DEN230027 - NaviCam ProScan
- Premarket Approval Application and Humanitarian Device Exemption Modular Review - Guidance for Industry and FDA Staff
- Class I Recall: Outpatient Telemetry Correction: Philips Issues Correction for Monitoring Service Application used with Mobile Cardiac Outpatient Telemetry Due to Potential for Missed Information or Notifications That May Impact Patient Care
- Recalls, Corrections and Removals (Devices) (Updated)
January 8, 2025
- COVID-19 Tests Granted Traditional Marketing Authorization by the FDA - Molecular Diagnostic Tests (Updated)
- DASH SARS-CoV-2 & Flu A/B Test (Nuclein, LLC)
- Getting a Radiation Emitting Product to Market: Frequently Asked Questions (Updated)
- Laboratory Developed Tests (Updated)
- Consumer Information: PyloPlus UBT System - P170022/S003 (ARJ Medical Inc.)
- Federal Register: Requests for Nominations: Technical Electronic Product Radiation Safety Standards Committee
January 7, 2025
- Consumer Information: Oncomine Dx Target Test - P160045/S046 (Life Technologies Corporation)
January 6, 2025
- Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations - Draft Guidance for Industry and Food and Drug Administration Staff
- Pulse Oximeters (Updated)
- Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency - Draft Guidance for Industry and Food and Drug Administration Staff
- Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations - Draft Guidance for Industry and Food and Drug Administration Staff
- 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
- Medical Device Supply Chain and Shortages (Updated)
- Supply and Shortages of Medical Devices: Frequently Asked Questions (Updated)
- 506J Device List (Updated)
- Federal Register: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff
January 3, 2025
January 2, 2025
- Total Product Life Cycle Advisory Program (TAP) (Updated)
- MQSA National Statistics (Updated)
December 31, 2024
December 30, 2024
- February 20, 2025: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
- Early Alert: Extracorporeal Blood Circuit Issue from Nuwellis
- Early Alert: Fluid Delivery Set Issue from Medline
- Home as a Health Care Hub (Updated)
December 27, 2024
- Federal Register: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of Public Docket; Request for Comments--Dermal Fillers
- Federal Register: Requests for Nominations: Individuals and Consumer Organizations for Advisory Committees
- Federal Register: Requests for Nominations: Patient Engagement Advisory Committee
December 23, 2024
- De Novo Reclassification Order(s):
- De Novo Decision Summary:
- DEN240014 - ARCEX System
- Biocompatibility and Toxicology Program: Research on Medical Devices, Biocompatibility, and Toxicology (Updated)
- Early Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus
December 20, 2024
- Clinical Decision Support Software Frequently Asked Questions (FAQs)
- Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices (Updated)
- Early Alert: Nephroscope Sheath Issue from Trokamed GmbH
- Class I Recall: Infusion Pump Battery Recall: ICU Medical Removes Some CSB Batteries Intended For Use With Plum 360, A+, and A+3 Infusion Systems Due to Reports of Allegedly Counterfeit, Untested Batteries In Use
- Medical Device Sterilization Town Hall: Sterilization Short Topics, Series Impact, Wrap Up, and Next Steps - December 4, 2024
December 19, 2024
December 18, 2024
- Class I Recalls:
- Implantable Marker Recall: Hologic Removes BioZorb 3D Bioabsorbable Markers due to Risk for Patient Complications
- Catheter Correction: Boston Scientific Updates Use Instructions for POLARx and POLARx FIT Cryoablation Balloon Catheters due to Higher than Anticipated Number of Reports of Atrio-Esophageal Fistula
December 17, 2024
- Global Unique Device Identification Database (GUDID) - Guidance for Industry and Food and Drug Administration Staff
- Global Unique Device Identification Database (GUDID) (Updated)
- Prepare for GUDID (Updated)
- Submit Data to GUDID (Updated)
- Collaborative Communities: Addressing Health Care Challenges Together - Participating in Connected Health Collaborative Community (Updated)
December 16, 2024
- De Novo Decision Summaries (Updated):
- De Novo Reclassification:
- DEN240025 - VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail Assay
- Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement - FDA Safety Communication
December 11, 2024
- Consumer Information: nAbCyte Anti-AAVRh74var HB-FE Assay - H230005 (LabCorp Drug Development)
- Early Alert: Infusion Pump Issue from Fresenius Kabi USA
- 2024 Medical Device Recalls (Updated)
- Federal Register: Emergency Use Authorization: B. Braun Medical's Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, and Outlook ES; Revocation
December 10, 2024
- De Novo Decision Summaries (Updated):
- MedSun Newsletter - December 2024
December 9, 2024
December 6, 2024
- Class I Recall: Neonatal Incubator Correction: GE HealthCare Updates Use Instructions for GE HealthCare Giraffe OmniBed Carestation and Incubator Carestation due to Risk of Patient Formaldehyde Exposure
- CDRH Learn: Presentation and Transcript posted for Registration & Listing Requirements for In Vitro Diagnostic Products (IVDs), Including Laboratory Developed Tests (LDTs) Webinar - December, 3, 2024
December 5, 2024
- Reports on Non-Device Software Functions
- 2024 Report on Non-Device Software Functions (PDF - 1.72 MB)
- Revised Emergency Use Authorizations
- Quest Diagnostics Mpox Virus Qualitative Real-Time PCR (2-well) (Quest Diagnostics Nichols Institute)
December 4, 2024
- Class I Recall: Syringe Recall: Cardinal Health Removes Certain Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Packs due to Incompatibility with Needleless Connectors
- Medical Device Shortages List (Updated)
- Consumer Information: Esprit BTK Everolimus Eluting Resorbable Scaffold System - P230036 (Abbott Medical)
December 3, 2024
- De Novo Decision Summaries (Updated):
- De Novo Classification Order:
- Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions - Guidance for Industry and Food and Drug Administration Staff
- Webinar – Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
- Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles (Updated)
- Artificial Intelligence and Machine Learning in Software as a Medical Device (Updated)
- Guidances with Digital Health Content (Updated)
- Medical Device Single Audit Program (MDSAP) (Updated)
- Consumer Information: Lumicelli Direct Visualization System - P230014 (Lumicell, Inc.)
- Medical Device Sterilization Town Hall: Sterilization Short Topics, Series Impact, Wrap Up, and Next Steps - December 4, 2024
- Federal Register: Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
December 2, 2024
- GUDID Data Trends (Updated)
November 29, 2024
- Class I Recalls
- Biopsy Needle Recall: Elekta Removes Disposable Biopsy Needle Kits due to Risk of Microscopic Stainless Steel Debris Inside Needle
- Insertion Tube Recall: FHC Removes microTargeting Insertion Tube Sets due to a Manufacturing Size Error That May Lead to Patient Harm
- Hemodialysis Correction: Baxter Issues Correction for AK 98 Hemodialysis Machines Due to Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA and/or NDL-PCBs
- Peritoneal Dialysis Set Correction: Baxter Issues Correction for MiniCap Extended Life Peritoneal Dialysis Transfer Sets Due to Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA and/or NDL-PCBs
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Administrative Detention and Banned Medical Devices
November 26, 2024
- Medical Device Sterilization Town Hall: Sterilization Short Topics, Series Impact, Wrap Up, and Next Steps, December 4, 2024
- Sterilization for Medical Devices (Updated)
November 25, 2024
- Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices - Guidance for Industry and Food and Drug Administration Staff
- November 22, 2024 MDUFA V Performance Report
- Total Product Life Cycle Advisory Program (TAP) (Updated)
- Federal Register: Guidance: Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices
November 22, 2024
- CDRH Petitions (Updated)
November 21, 2024
- Standards Newsletter from the Division of Standards and Conformity Assessment
- Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff
- Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff
- CDRH Announces Communications Pilot to Enhance Medical Device Recall Program
- Federal Register: Guidance: Orthopedic Non-Spinal Bone Plates, Screws, and Washers--Premarket Notification (510(k)) Submissions
November 20, 2024
- 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review - Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations
- Federal Register: Guidance: 510(k) Third Party Review Program and Third Party Emergency Use Authorization Review
November 19, 2024
- Class I Recall:
- Battery Pack Correction: Smiths Medical Updates Use Instructions for CADD-Solis Li-ion Rechargeable Battery Packs Due to Risk That Pack Damage May Cause a Circuit Short and Prevent Recharge
- Ventilator Correction: Philips Updates Use Instructions for Trilogy Evo, EvoO2, EV300, Evo Universal, Aeris EVO, Garbin Evo, and LifeVent EVO2, due to Risk of Inaccurate Flow Measurements Caused by Certain In-Line Nebulizer Placements
- Anesthesia Machine Correction: Draeger, Inc., Issues Correction for Atlan A350 and A350 XL Anesthesia Workstations Due to Possible Mechanical Ventilation Failure
- Medical Device Development Tools (MDDT) - Summary of Evidence and Basis of Qualification For WOUND-Q
- Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A - November 20, 2024
- Revised Emergency Use Authorizations
- NxTAG Respiratory Pathogen Panel + SARS-CoV-2 03/03/2021 (Luminex Molecular Diagnostics, Inc.)
- Nano-Check Influenza+COVID-19 Dual Test (Nano-Ditech Corporation)
- Federal Register: Emergency Use Authorization: In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Revocation
November 18, 2024
- Agenda and Roster for November 20-21, 2024 Digital Health Advisory Committee Meeting
- De Novo Decision Summaries (Updated):
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- Revised Emergency Use Authorizations
- ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test (Princeton BioMeditech Corp.)
November 15, 2024
- Consumer Information: GORE EXCLUDER Conformable AAA Endoprostheses (EXCC) - P200030/S014 (W.L. Gore & Associates, Inc.)
- Consumer Information: TruSight Oncology Comprehensive - P230011 (Illumina, Inc)
- Consumer Information: Simplera system - P160007/S047 (Medtronic MiniMed, Inc.)
- Consumer Information: UNIPURE SF6 Ophthalmic Gas UNIFEYE Gas Delivery System and UNIPURE SF6 Ophthalmic Gas UNIPEXY Gas Delivery System - P230012 (Alcon Research, LLC)
- Class I Recall: Endoscopic Vessel Harvesting System Recall: Getinge and Maquet Cardiovascular Remove VasoView HemoPro 1 and 1.5 Endoscopic Vessel
- Safety and Availability Concerns with VasoView HemoPro Endoscopic Vessel Harvesting Systems - Letter to Health Care Providers
- Medical Device Shortages List (Updated)
- Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A - November 20, 2024
- List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)
November 14, 2024
- Blood Glucose Monitoring Devices (Updated)
- De Novo Decision Summaries (Updated):
- De Novo Classification Order:
November 12, 2024
- Updated Emergency Use Authorization
November 8, 2024
- Reclassification (Updated)
- Evaluation of Airborne Chemicals from Neonatal Incubators - Letter to Health Care Providers (Updated)
November 7, 2024
- Breakthrough Devices Program (Updated)
- Presentation and Transcript added to Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A - October 30, 2024
- Alternative Standards (MQSA): #25: Issuing a Report with the Assessment “Incomplete: Need additional imaging evaluation” in Follow-Up to an Initial Report with the Assessment “Incomplete: Need prior mammograms for comparison.”
November 6, 2024
- Updated Emergency Use Authorization
- CDRH – A Great Place for Public Health Service Officers to Work
November 5, 2024
November 4, 2024
- De Novo Decision Summaries (Updated):
- MedSun Newsletter - November 2024
- Explore Life at CDRH (Updated)
- MQSA National Statistics (Updates)
November 1, 2024
- Class I Recall: IPV Therapy Device Recall: Percussionaire Removes Certain Phasitron 5 Breathing Circuits Due to Risk of Nickel Exposure