CDRHNew - News and Updates
January 14, 2022
- Personal Protective Equipment EUAs - Appendix A: Authorized Surgical Masks (Updated)
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Consumer Information on: SCOREFLEX NC SCORING PTCA CATHETER – P200041
- Consumer Information on: Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent – P200015/S011
- Medical Device Types to Help Determine Section 506J Notification Obligations (Updated)
January 13, 2022
- Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems - FDA Safety Communication
- 510(k) Third Party Performance Metrics and Accreditation Status (Updated)
January 12, 2022
- Updated Emergency Use Authorizations
- Medical Device Material Safety Summaries: ECRI Reports (Updated)
- Federal Register: Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications
January 11, 2022
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication
- Consumer Information on: OrganOx metra® System - P200035
January 10, 2022
- New Emergency Use Authorization
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- AQ-TOP COVID-19 Rapid Detection Kit (Seasun Biomaterials, Inc.)
- cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) (Roche Molecular Systems)
- cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System (Roche Molecular Systems, Inc.)
- FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR) (PreciGenome LLC)
- PowerChek 2019-nCoV Real-time PCR Kit (KogeneBiotech Co., Ltd.)
- PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 (PerkinElmer, Inc.)
- BinaxNOW COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.)
- BinaxNOW COVID-19 Ag Card Home Test (Abbott Diagnostics Scarborough, Inc.)
- BinaxNOW COVID-19 Ag Card 2 Home Test (Abbott Diagnostics Scarborough, Inc.)
- BinaxNOW COVID-19 Ag 2 Card (Abbott Diagnostics Scarborough, Inc.)
- Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act - Draft Guidance for Industry and Staff
- Class I Recall: Cardiovascular Systems, Inc Recalls WIRION Embolic Protection Device Due to Complaints of Filter Breakage During Retrieval
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210015 added)
- Federal Register: Permanent Discontinuance or Interruption in Manufacturing of a Device under the Federal Food, Drug, and Cosmetic Act
January 7, 2022
- Revoked Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
- Medical Device Types to Help Determine Section 506J Notification Obligations (Updated)
- Consumer Information on: SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface Assembly – P200040
January 6, 2022
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Class I Recall: Medtronic Recalls Synergy Cranial and StealthStation S7 Cranial Software Due to Potential Risk of Inaccurate Biopsy Depth Gauge Cycle View
January 5, 2022
- MedSun Newsletter, January 2022
- Summary Minutes for October 6, 2021 Patient Engagement Advisory Committee Meeting
January 4, 2022
- GUDID Data Trends - November 2021
- Webinar - Content of Premarket Submissions for Device Software Functions, Draft Guidance - Presentation and Transcript added
January 3, 2022
- Consumer Information on:
- Class I Recall: Covidien, LP Recalls Puritan Bennett 980 Series Ventilator Due to Manufacturing Assembly Error
- MQSA National Statistics as of January 1, 2022
December 30, 2021
December 28, 2021
- New Emergency Use Authorization
- Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - December 15, 2021
- SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)
- Federal Register: Gastroenterology-Urology Devices; Classification of the Transcutaneous Electrical Continence Device
- Federal Regiser: Neurological Devices; Classification of the Cerebrospinal Fluid Shunt System
- Federal Register: Neurological Devices; Classification of the Diagnostic Neurosurgical Microscope Filter
December 27, 2021
- New Emergency Use Authorization
- SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)
- Federal Register: Medical Devices: Anesthesiology Devices; Classification of the Retrograde Intubation Device
December 23, 2021
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH) - Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia
December 22, 2021
- SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)
- Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions - Draft Guidance for Industry and Food and Drug Administration Staff
- Credibility of Computational Models Program: Research on Computational Models and Simulation Associated with Medical Devices (Updated)
- Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology - Draft Guidance for Industry and Food and Drug Administration Staff
- Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Draft Guidance for Industry and Food and Drug Administration Staff
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Draft Guidance for Industry and Food and Drug Administration Staff
- Webinar on Draft Guidances on Transition Plans for COVID-19 Related Medical Devices - February 22, 2022
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - December 1, 2021 - Presentation and Transcript added
- Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
- Getinge’s Maquet/Datascope IABP Devices: Update on Device Failure - Letter to Health Care Providers
- Cybersecurity (Updated)
December 21, 2021
- Webinar - Hearing Aids and Personal Sound Amplification Products - Presentation, Printable Slides, Transcript added
- Webinar - Content of Premarket Submissions for Device Software Functions, Draft Guidance - Printable slides added
- January and February 2022 Dates Announced for the Virtual Town Hall Series for Test Developers on Coronavirus (COVID-19)
December 20, 2021
- New Emergency Use Authorizations
- Re-Issued Emergency Use Authorizations
- Quest Diagnostics RC COVID-19+Flu RT-PCR (Quest Diagnostics Nichols Institute)
- Quest Diagnostics Collection Kit for COVID (Quest Diagnostics Nichols Institute)
- Quest Diagnostics PF SARS-CoV-2 Assay(Quest Diagnostics Nichols Institute)
- Quest Diagnostics RC SARS-CoV-2 Assay (Quest Diagnostics Nichols Institute)
- Quest SARS-CoV-2 rRT-PCR (Quest Diagnostics Nichols Institute)
- cPass SARS-CoV-2 Neutralization Antibody Detection Kit (GenScript USA Inc.)
- Revised Emergency Use Authorizations
- PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 (PerkinElmer, Inc.)
- Sienna-Clarity COVID-19 Antigen Rapid Test Cassette (Salofa Oy)
- Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 (STS Lab Holdco (a subsidiary of Amazon.com Services LLC)
- Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test (STS Lab Holdco (a subsidiary of Amazon.com Services LLC)
- Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test STS Lab Holdco (a subsidiary of Amazon.com Services LLC)
- Updated Emergency Use Authorizations
- Simplexa COVID-19 Direct assay (DiaSorin Molecular LLC)
- ZEUS ELISA SARS-CoV-2 Total Antibody Test System (ZEUS Scientific, Inc.)
- MAGLUMI 2019-nCoV IgM/IgG (Shenzhen New Industries Biomedical Engineering Co., Ltd.)
- ACON SARS-CoV-2 IgG/IgM Rapid Test (ACON Laboratories, Inc.)
- FREND COVID-19 total Ab (NanoEntek America, Inc.)
- Access SARS-CoV-2 IgM (Beckman Coulter, Inc.)
- Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit (Biohit Healthcare (Hefei) Co. Ltd.)
- Babson Diagnostics aC19G1 (Babson Diagnostics, Inc.)
- Revoked Emergency Use Authorizations
- Consumer Information on: Spatz3 Adjustable Balloon System - P190012
December 17, 2021
- Cybersecurity Vulnerability with Apache Log4j
- Ethylene Oxide Sterilization for Medical Devices (Updated)
- Voluntary eSTAR Program (Updated)
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Possible False RPR Reactivity with BioPlex 2200 Syphilis Total & RPR Test Kit Following a COVID-19 Vaccine - Letter to Clinical Laboratory Staff and Health Care Providers
December 16, 2021
- Class I Recall: Getinge/Datascope/Maquet Recalls Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Due to Reports of Fluid Leaks
- Nucleic Acid Based Tests (Updated)
- 24 Hour Summary and Presentations for December 10, 2021 Neurological Devices Panel of the Medical Devices Advisory Committee Meeting
- Federal Register: Requests for Nominations: Voting Members on Public Advisory Panels of the Medical Devices Advisory Committee
- Federal Register: Medical Devices: General and Plastic Surgery Devices; Classification of the Manual Percutaneous Surgical Set Assembled in the Abdomen
December 15, 2021
- Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents - Draft Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Guidance: Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents
- Federal Register: Medical Devices: Neurological Devices; Classification of the Traumatic Brain Injury Eye Movement Assessment Aid
- SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)
- ASCA-Accredited Testing Laboratories (Updated)
December 14, 2021
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200041 added)
- Transcripts for November 2-3, 2021 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
- Job Opportunities at OSEL
- Federal Register: Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures
- Federal Register: Gastroenterology-Urology Devices; Classification of the Endoscopic Transhepatic Venous Access Needle
- Federal Register: Gastroenterology-Urology Devices; Classification of the Nonimplanted Nerve Stimulator for Functional Abdominal Pain Relief
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