CDRHNew - News and Updates
December 13, 2021
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Revoked Emergency Use Authorizations
December 10, 2021
- MedSun Newsletter, December 2021
- 3D Printing Medical Devices at the Point of Care: Discussion Paper
- FDA In Brief: FDA Publishes Discussion Paper and Seeks Public Input on 3D Printing of Medical Devices at the Point of Care
- SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Federal Register: Gastroenterology-Urology Devices; Classification of the Pressure Ulcer Management Tool
- Federal Register: Neurological Devices; Classification of the Temporary Coil Embolization Assist Device
December 9, 2021
- New Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Revoked Emergency Use Authorizations
- BMC-CReM COVID-19 Test (Boston Medical Center)
- Akron Children's Hospital SARS-CoV-2 Assay (Akron Children’s Hospital)
- BioGX SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson & Company (BD))
- Federal Register: Gastroenterology-Urology Devices; Classification of the Ingested, Transient, Space Occupying Device for Weight Management and/or Weight Loss
- Federal Register: General and Plastic Surgery Devices; Classification of the Negative Pressure Wound Therapy Device for Reduction of Wound Complications
- Federal Register: Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for Attention Deficit Hyperactivity Disorder
- Federal Register: Modifications to the List of Recognized Standards, Recognition List Numbers: 056
- SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)
December 8, 2021
- Materials for December 10, 2021 Neurological Devices Panel of the Medical Devices Advisory Committee Meeting
- Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - November 17, 2021
- Radiological Health Program (Updated)
- FDA eSubmitter (Updated)
- CDRH eSubmitter Program (Updated)
- Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 056
December 7, 2021
- SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)
- Industry Discussions on MDUFA V Reauthorization (Updated)
- Evaluation of Automatic Class III Designation (De Novo) Summaries ( DEN200005 and DEN210012 added)
- Federal Register: Medical Devices; Exemption from Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport
December 6, 2021
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)
- Transcript for Orthopedic Strategically Coordinated Registry Network Meeting - 11/04/2021
December 3, 2021
- Class I Recall: Arrow International Inc Recalls Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7Fr, Due to Risk of Separation
- EUA Authorized Serology Test Performance (Updated)
- SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
December 2, 2021
- Consumer Information on: Portico Transcatheter Aortic Valve Implantation System - P190023
- Paclitaxel-Coated Balloons and Stents for Peripheral Arterial Disease
- August 7, 2019 UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality (Updated)
- Federal Register: Request for Nominations: National Mammography Quality Assurance Advisory Committee
- Federal Register: Request for Nominations: National Mammography Quality Assurance Advisory Committee
December 1, 2021
- New Emergency Use Authorizations
- Re-Issued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- UPDATE: Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices - Letter to Health Care Providers
- List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)
- Reclassification (Updated)
- MQSA National Statistics as of December 1, 2021
- Federal Register: Anesthesiology Devices; Classification of the Isocapnic Ventilation Device
- Federal Register: Gastroenterology-Urology Devices; Classification of the Esophageal Tissue Characterization System
- Federal Register: Neurological Devices; Classification of the Conditioning Tool for Eating Disorders
- Federal Register: Neurological Devices; Classification of the Trunk and Limb Electrical Stimulator to Treat Headache
- Federal Register: Orthopedic Devices; Classification of the Intraoperative Orthopedic Strain Sensor
November 30, 2021
November 29, 2021
- Transcript for October 20, 2021 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
- Premarket Submissions: Selecting and Preparing the Correct Submission (Updated)
- Voluntary eSTAR Program
- Federal Register: Requests for Nominations: Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee
November 26, 2021
November 24, 2021
November 23, 2021
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
November 22, 2021
- New Emergency Use Authorizations
- Reissused Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Federal Register: General and Plastic Surgery Devices; Classification of the General Laparoscopic Power Morcellation Containment System
November 19, 2021
- Safely Using Sharps (Needles and Syringes) at Home, at Work and on Travel (Updated)
- Reclassification (Updated)
- FDA In Brief: FDA Issues Final Orders Reclassifying Certain Hepatitis C Diagnostic Tests from Class III to Class II
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Federal Register: Effective Date of Requirement for Premarket Approval for Blood Lancets
- Federal Register: General and Plastic Surgery Devices; Reclassification of Blood Lancets
- Federal Register: Reclassification of Certain Hepatitis C Virus Antibody Assay Devices, Renamed to Hepatitis C Virus Antibody Tests
- Federal Register: Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, Renamed to Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests
- Federal Register: Administrative Detention and Banned Medical Devices
November 18, 2021
- Potential for Medication Overdose with ENFit Low Dose Tip Syringe: FDA Safety Communication (Updated)
- Federal Register: Guidance: Website Location of Center for Devices and Radiological Health Fiscal Year 2022
November 17, 2021
- MDUFA IV Performance Report - 4th Quarter FY2021
- Leadless Pacing Systems: Risk of Major Complications Related to Cardiac Perforation During Implantation - Letter to Health Care Providers
November 16, 2021
- Medical Device Development Tools (MDDT) (Updated)
November 15, 2021
- Reissued Emergency Use Authorizations
- Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Guidance for Developers and Food and Drug Administration Staff
- Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) - Guidance for Commercial Manufacturers, Clinical Laboratories, and Food and Drug Administration Staff
- Coronavirus (COVID-19) and Medical Devices (Updated)
- FAQs on Testing for SARS-CoV-2 (Updated)
- Reissued the EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests
- Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing
- FDA News Release: Coronavirus (COVID-19) Update: FDA Updates Test Policies to Help to Ensure Accuracy and Reliability of Tests and Increase Access to At-Home Tests
- Consumer Information on: Vercise™ PC, Vercise Gevia™ and Vercise Genus™ Deep Brain Stimulation (DBS) System - P150031/S040
- Consumer Information on: Ki-67 IHC MIB-1 pharmDx (Dako Omnis) - P210026
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210006 added)
November 12, 2021
- Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication
- Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions (Updated)
November 10, 2021
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Consumer Information on: ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters – P200004
- Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results
- Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue: FDA Safety (Updated)
- Activities to Support Medical Device Innovators (Updated)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200033 added)
November 9, 2021
- Molecular and Antigen Home Use Test Template (Updated)
- 24 Hour Summaries posted for November 2-3, 2021 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
- Class I Recall: Aligned Medical Solutions Doing Business as Windstone Medical Packaging, Inc. Recalls Custom Convenience Kits Due to Cardinal Health Monoject Flush Prefilled Syringe (0.9% Sodium Chloride) Plunger Defect