CDRHNew - News and Updates
A comprehensive list of the latest CDRH updates.
This Week in CDRH
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
October 31, 2024
October 29, 2024
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- Webinar – FDA’s Total Product Life Cycle Approach to In Vitro Diagnostic Products (IVDs), October 24, 2024
- Update: Use of GE HealthCare EVair and EVair 03 Compressors - Letter to Health Care Providers
- Class I Recall: Air Compressor Device Correction: GE HealthCare Provides Updates to EVair Compressors Due to Final Formaldehyde Testing Results
- CDRH Learn (Updated Presentations)
October 28, 2024
- Cybersecurity (Updated)
- De Novo Decision Summaries (Updated):
- Meeting materials for October 30, 2024 Patient Engagement Advisory Committee Meeting
- In Vitro Diagnostics (IVD) Roundtable – Fall Meeting
- Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A
October 25, 2024
- Class I Recall:
- Update: Do Not Use BioZorb Marker Implantable Radiographic Marker Devices: FDA Safety Communication
October 24, 2024
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Webinar – FDA’s Total Product Life Cycle Approach to In Vitro Diagnostic Products (IVDs), October 24, 2024
- Class I Recall: Ventilator Correction: Baxter Healthcare Updates Use Instructions for Life2000 Ventilation System Due to Risk of No Low Gas Pressure Alarm
October 23, 2024
October 22, 2024
- IDE Application (Updated)
October 21, 2024
- De Novo Classification Order:
- De Novo Decision Summaries (Updated):
- Reclassification (Updated)
- Federal Register: Chemical Analysis for Biocompatibility Assessment of Medical Devices
October 18, 2024
- Total Product Life Cycle Advisory Program (TAP) (Updated)
- Class I Recall: Vascular Embolization Device Correction: Boston Scientific Updates Use Instructions for Obsidio Conformable Embolic for Increased Ischemia Risk When Used for GI Bleeding
- Webinar - Draft Guidance: Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle - 10/15/2024 (Updated)
October 17, 2024
- Class I Recall: Insulin Pump Recall: Medtronic Notifies Users of MiniMed 600 and 700 Series Pumps of Risk of Shorter than Expected Battery Life
- Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A
- Federal Register: Accreditation Scheme for Conformity Assessment Program
October 16, 2024
- Ventilators and Ventilator Accessories EUAs (Updated)
- CDRH Petitions (Updated)
October 15, 2024
- Influenza Diagnostic Tests (Updated)
- Electronic Medical Devices, X-ray Imaging and Radiation Therapy: What to Know and How to Prevent Damage
- Device Trial Participation Snapshots
- De Novo Classification Order: DEN240029 - Healgen Rapid Check COVID-19/flu A&B Antigen Test
- De Novo Decision Summaries (Updated):
- DEN200076 - ORi
- DEN210058 - ELEOSx™ Limb Salvage System
- DEN220015 - Orthobond Mariner Pedicle Screw System
- DEN220073 - Revi System
- DEN230008 - DermaSensor
- DEN230035 - DentalMonitoring
- DEN230043 - Notal Vision Home Optical Coherence Tomography (OCT) System
- DEN230081 - Hearing Aid Feature
- DEN240013 - MagDI System
October 11, 2024
- Revoked Emergency Use Authorizations
- Endosseous Dental Implants and Endosseous Dental Implant Abutments - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff
- Safety and Performance Based Pathway (Updated)
- Class I Recall: Infusion Pump Recall: Zyno Medical Removes Certain Z-800, Z-800F, Z-800W, and Z800WF Infusion Pumps due to an Air-in-Line Software Defect That May Allow Larger than Expected Air Bubbles to Enter Patients
- Federal Register: Medical Devices: Quality System; Correction
- Federal Register: Endosseous Dental Implants and Endosseous Dental Implant Abutments -Performance Criteria for Safety and Performance Based Pathway
October 10, 2024
October 8, 2024
- Consumer Information: SHIELD - P230009 (Guardant Health, Inc.)
- Resources and Interactions with FDA: Laboratory Developed Tests FAQs (Updated)
- Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A - October 9, 2024
October 7, 2024
- Consumer Information: UNIPURE C3F8 Ophthalmic Gas, UNIFEYE Gas Delivery System, UNIPLEX Gas Delivery System - P220030 (Alcon Research, LLC)
- Consumer Information: MYNX Control™ Venous Closure Device (VCD) - P040044/S097 (Cordis US Corporation)
- De Novo Decision Summaries (Updated):
- De Novo Classification Orders:
- CDRH's Experiential Learning Program (ELP) (Updated)
- Experiential Learning Program (ELP) Areas of Interest (Updated)
- Class I Recall: Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitators due to Risk of Inline Controller Detachment that May Impact Ventilation
October 4, 2024
- Revoked Emergency Use Authorization
- Total Product Life Cycle Advisory Program (TAP) (Updated)
October 3, 2024
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorization
- Send and Track Medical Device Premarket Submissions Online: CDRH Portal (Updated)
- CDRH Learn: MDUFA Small Business Program (Updated)
- MedSun Newsletter - October 2024
October 2, 2024
- MQSA National Statistics (Updated)
- Class I Recall: IPV Therapy Device Correction: Sentec/Percussionaire Updates Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental Misuse of Expiratory Port Plug
- Medical Device Shortages List (Updated)
October 1, 2024
- Class I Recall: Infusion Pump Software Correction: Fresenius Kabi USA, LLC, Issues Correction for Ivenix Infusion System Large Volume Pump (LVP) Software due to Multiple Anomalies that May Cause Delay or Underdosage of Therapy
- Class I Recall: Ventilator Software Correction: Philips Respironics Issues Mandatory Software Correction and Updates Use Instructions for Trilogy Evo, EV300, EvoO2, and Evo Universal to Address Multiple Issues that May Impact Ventilation
- Webinar - Registration & Listing Requirements for In Vitro Diagnostic Products (IVDs), Including Laboratory Developed Tests (LDTs) - 12/03/2024
- Total Product Life Cycle Advisory Program (TAP) (Updated)