CDRHNew - News and Updates
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- Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions - Draft Guidance for Industry and Food and Drug Administration Staff (Comment period extended)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
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