CDRHNew - News and Updates
February 15, 2022
February 14, 2022
- Updated Emergency Use Authorizations
- Tracking Your Premarket Submission's Progress (Progress Tracker) (Updated)
- FDA Activities Related to Essure (Updated)
- Information for Patients and Health Care Providers: Essure (Updated)
February 11, 2022
- FAQs on Viral Transport Media During COVID-19 (Updated)
- ASCA-Accredited Testing Laboratories (Updated)
- Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 26, 2022
- Federal Register: Cardiovascular Devices; Classification of the Adjunctive Predictive Cardiovascular Indicator
- Federal Register: General Hospital and Personal Use Devices; Classification of the Spore Test Strip
February 10, 2022
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Elecsys Anti-SARS-CoV-2 S (Roche Diagnostics, Inc.)
- Anti-SARS-CoV-2 ELISA (IgG) (EUROIMMUN US Inc.)
- Cue COVID-19 Test for Home and Over The Counter (OTC) Use (Cue Health Inc.)
- Appendix A: Authorized Molecular-Based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 - Removal of SARS-CoV-2 Test (Biocerna)
- Revised Emergency Use Authorizations
- Revoked Emergency Use Authorization
February 8, 2022
- January 2022 PMA Approval List
- Potential Risk of Strangulation in Children Who Use Enteral Feeding Delivery Sets - FDA Safety Communication
February 7, 2022
- New Emergecy Use Authorization
- Reissued Emergency Use Authorizations
- BinaxNOW COVID-19 Ag Card Home Test (Abbott Diagnostics Scarborough, Inc.)
- BinaxNOW COVID-19 Ag 2 Card (Abbott Diagnostics Scarborough, Inc.)
- ADEXUSDx COVID-19 Test (NOWDiagnostics, Inc.)
- LetsGetChecked Coronavirus (COVID-19) (LetsGetChecked, Inc.)
- PMLS SARS-CoV-2 Assay (Premier Medical Laboratory Services)
- Revised Emergency Use Authorizations
- BinaxNOW COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.)
- Nano-Check COVID-19 Antigen Test (Nano-Ditech Corp.)
- Assure COVID-19 IgG/IgM Rapid Test Device (Assure Tech. (Hangzhou Co., Ltd))
- cPass SARS-CoV-2 Neutralization Antibody Detection Kit (GenScript USA Inc.)
- PerkinElmer New Coronavirus Nucleic Acid Detection Kit (PerkinElmer, Inc.)
- Advanta Dx SARS-CoV-2 RT-PCR Assay (Fluidigm Corporation)
- Color COVID-19 Self-Swab Collection Kit with Saline (Color Health, Inc.)
- Updated Emergency Use Authorization
- Federal Register: Establishment Registration and Device Listing for Manufacturers and Importers of Devices
February 4, 2022
- Consumer Information on: Nucleus 24 Cochlear Implant System - P970051/S205
- Do Not Use E25Bio COVID-19 Tests: FDA Safety Communication
- MedSun Newsletter, February 2022
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200080 Decision Summary Added)
- 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
February 3, 2022
- CDRH Strategic Priorities and Updates (Updated)
- Federal Register: Cardiovascular Devices; Classification of the Photoplethysmograph Analysis Software for Over-the-Counter Use
- Federal Register: General and Plastic Surgery Devices; Classification of the Carbon Dioxide Gas Controlled Tissue Expander
- Federal Register: General Hospital and Personal Use Devices; Classification of the Alternate Controller Enabled Infusion Pump
- Federal Register: Immunology and Microbiology Devices; Classification of the System for Detection of Microorganisms and Antimicrobial Resistance Using Reporter Expression
February 2, 2022
February 1, 2022
- MQSA National Statistics
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - February 9, 2022
January 31, 2022
- Reissued Emergency Use Authorizations
- SalivaDirect (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
- 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 (STS Lab Holdco (a subsidiary of Amazon.com Services LLC))
- COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) (Healgen Scientific LLC)
- InteliSwab COVID-19 Rapid Test Rx (OraSure Technologies, Inc.)
- InteliSwab COVID-19 Rapid Test (OraSure Technologies, Inc.)
- InteliSwab COVID-19 Rapid Test Pro (OraSure Technologies, Inc.)
- SCoV-2 Ag Detect Rapid Self-Test (InBios International Inc.)
- Revised Emergency Use Authorization
- Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test (STS Lab Holdco (a subsidiary of Amazon.com Services LLC))
- Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 (STS Lab Holdco (a subsidiary of Amazon.com Services LLC))
- Color COVID-19 Self-Swab Collection Kit (Color Health, Inc.)
- Color COVID-19 Self-Swab Collection Kit DTC (Color Health, Inc.)
- Psoma COVID-19 RT Test (Psomagen, Inc.)
- Updated Emergency Use Authorizations
- CDRH 2021 Annual Report
January 28, 2022
- Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication
- Class I Recall: Empowered Diagnostics Recalls COVID-19 Tests due to Risk of False Results
January 27, 2022
- Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions - Draft Guidance for Industry and Food and Drug Administration Staff (Comment period extended)
- Credibility of Computational Models Program: Research on Computational Models and Simulation Associated with Medical Devices (Updated)
- Federal Register: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions
- Federal Register: Export of Medical Devices; Foreign Letters of Approval
January 26, 2022
- ASCA 2021 Annual Report
- Philips Respironics Recalls Certain Trilogy EVO Ventilators for Potential Health Risks from PE-PUR Foam
- Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication (Updated)
- Philips Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked Questions (Updated)
January 25, 2022
- Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation - Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders
- Patient Engagement in the Design and Conduct of Medical Device Clinical Studies - Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
- CDRH Patient Engagement (Updated)
- Clinical Outcome Assessments (COAs) in Medical Device Decision Making (Updated)
- Webinar - Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation - Final Guidance - March 1, 2022
- Webinar - Patient Engagement in the Design and Conduct of Medical Device Clinical Studies - Final Guidance - March 22, 2022
- Federal Register: Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation
- Federal Register: Patient Engagement in the Design and Conduct of Medical Device Clinical Studies
- Virtual Public Workshop –– Study Design Considerations for Transbronchoscopic Thermal Ablation Devices for the Treatment of Oligometastases to the Lung; April 5 & 6, 2022
January 24, 2022
- New Emergency Use Authorizations
- Updated Emergency Use Authorizations
- CareStart COVID-19 Antigen Home Test (Access Bio, Inc.)
- Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company)
- QuantiVirus SARS-CoV-2 Multiplex Test Kit (DiaCarta, Inc.)
- Illumina COVIDSeq Test (Illumina, Inc.)
- Viracor SARS-CoV-2 assay DTC (Viracor Eurofins Clinical Diagnostics)
- Viracor SARS-CoV-2 assay (Viracor Eurofins Clinical Diagnostics
- Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit (Diazyme Laboratories, Inc.)
- Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit (Diazyme Laboratories, Inc.)
- Dimension Vista SARS-CoV-2 Total antibody assay (COV2T) (Siemens Healthcare Diagnostics Inc.)
- Dimension EXL SARS-CoV-2 Total antibody assay (CV2T) (Siemens Healthcare Diagnostics Inc.)
- Atellica IM SARS-CoV-2 IgG (sCOVG) (Siemens Healthcare Diagnostics Inc.)
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200059 added)
- Federal Register: Guidance on Reagents for Detection of Specific Novel Influenza A Viruses
January 22, 2022
January 21, 2022
- Class I Recall: Medtronic Inc. Recalls HawkOne Directional Atherectomy System Due to Risk of Tip Damage During Use
- In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2 (Added Single or Multiple Targets to the Attributes column)
- In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2 (Added Single or Multiple Targets to the Attributes column)
- COVID-19 Test Development and Review: FAQs on Testing for SARS-CoV-2 (Updated)
- Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19
January 20, 2022
- Federal Register: Ophthalmic Devices; Classification of the Retinal Diagnostic Software Device
- Federal Register: Immunology and Microbiology Devices; Classification of Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests
- Federal Register: Emergency Use Authorization: In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Revocation
January 19, 2022
- Consumer Information on: Optilume® Urethral Drug Coated Balloon – P210020
- Consumer Information on: RHA Redensity - P170002/S012 (Dermal Filler)
- Class I Recall: Getinge USA Sales, LLC Recalls the Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems Due to a Risk of Harmful Chemical Exposure
- UPDATE: Blood Specimen Collection Tube Conservation Strategies - Letter to Health Care and Laboratory Personnel
- Blood Specimen Collection Tube Shortage: Frequently Asked Questions (Updated)
- Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
January 18, 2022
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Detect Covid-19 Test (Detect, Inc.)
- cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) (Roche Molecular Systems)
- Viracor SARS-CoV-2 assay (Viracor Eurofins Clinical Diagnostics)
- QuantiVirus SARS-CoV-2 Test kit (DiaCarta, Inc)
- U-TOP COVID-19 Detection Kit (SEASUN BIOMATERIALS)
- AQ-TOP COVID-19 Rapid Detection Kit PLUS (SEASUN BIOMATERIALS, Inc.)
- INDICAID COVID-19 Rapid Antigen Test (PHASE Scientific International, Ltd.)
- Revoked Emergency Use Authorizations
- CDRH Health of Women Program (Updated)
- Personal Protective Equipment EUAs - Appendix A: Authorized Surgical Masks (Updated)
- Consumer Information on: SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Exchange Delivery System – P210014
January 15, 2022
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)
- Federal Register: Cardiovascular Devices; Classification of the Electrocardiograph Software for Over-the-Counter Use