CDRHNew - News and Updates

  RSS News Feed for health professionals and consumers

  RSS News Feed for regulated industry

---

September 23, 2020

• New Emergency Use Authorizations
  • Clarifi COVID-19 Test Kit (Quadrant Biosciences Inc.)
  • ViroKey SARS-CoV-2 RT-PCR Test v2.0 (Vela Operations Singapore Pte. Ltd.)
• Updated Emergency Use Authorizations
  • ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit (ScienCell Research Laboratories)
  • BioGX SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson & Company (BD))
  • SARS-CoV-2 PCR Test (Centers for Disease Control and Prevention (CDC))
  • Color Genomics SARS-CoV-2 RT-LAMP Diagnostic Assay (Color Genomics, Inc.)
  • LabGun COVID-19 RT-PCR Kit (LabGenomics Co., Ltd.)
  • Assure COVID-19 IgG/IgM Rapid Test Device (Assure Tech. - Hangzhou Co., Ltd)
• Revoked Emergency Use Authorizations
  • Umbrella of Infusion Pumps and Infusion Pump Accessories
• FAQs on Testing for SARS-CoV-2 (Update)

September 22, 2020

• New Emergency Use Authorizations
  • KimForest SARS-CoV-2 Detection Kit v1 (KimForest Enterprise Co., Ltd.)
• Updated Emergency Use Authorizations
  • Lilly SARS-CoV-2 Assay (Eli Lilly and Company)
  • SARS-CoV-2 PCR Test (Diatherix Eurofins Laboratory)
• Digital Health Center of Excellence
• Webinar - Digital Health Center of Excellence Listening Session #1 - October 19, 2020
• Webinar - Digital Health Center of Excellence Listening Session #2 - November 12, 2020
• FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products
• Network of Experts Program: Connecting the FDA with External Expertise
• FAQs on Testing for SARS-CoV-2 (Updated)
• FAQs on Viral Transport Media During COVID-19 (Updated)

September 21, 2020

• Updated Emergency Use Authorizations
  • Appendix A: Authorized Surgical Masks
  • Bio-Rad SARS-CoV-2 ddPCR Test (Bio-Rad Laboratories, Inc.)
  • Infinity BiologiX TaqPath SARS-CoV-2 Assay (Infinity BiologiX LLC)
  • COVID-19 RT-PCR Test - Laboratory Corporation of America (LabCorp)
  • Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay (Ethos Laboratories)
  • SARS-CoV-2 IgG assay (Abbott Laboratories Inc.)
• New Emergency Use Authorizations
  • GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT (GK Pharmaceuticals Contract Manufacturing Operations)
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190032, DEN190039, DEN200010 added)
• Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices
• FAQs on Testing for SARS-CoV-2 (Updated)

September 18, 2020

• 24 Hour Summaries posted for September 8-9, 2020 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting
• Re-Issued Emergency Use Authorization
  • ID NOW COVID-19 (Abbott Diagnostics Scarborough, Inc.)
• FAQs on Testing for SARS-CoV-2 (Updated)
• FAQs on Viral Transport Media During COVID-19 (Updated)

September 17, 2020

• New Emergency Use Authorizations
  • Visby Medical COVID-19 (Visby Medical, Inc.)
  • MAGLUMI 2019-nCoV IgM/IgG (Shenzhen New Industries Biomedical Engineering Co., Ltd.)
• Virtual Public Meeting - FDA's Communications About the Safety of Medical Devices - November 17, 2020
• Presentation and Transcript added to Webinar - Multiple Function Device Products: Policy and Considerations - September 10, 2020
• FAQs on Testing for SARS-CoV-2 (Updated)
• Federal Register: Microbiology Devices: Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management, To Be Renamed Quantitative Cytomegalovirus Nucleic Acid Tests for Transplant Patient Management

September 16, 2020

• Meeting Notice: October 27, 2020 Circulatory System Devices Panel of the Medical Devices Advisory Committee
• Class I Recall: Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris™ Syringe and Alaris™ PCA Modules Due to Potential Incorrect Display of Syringe Types and/or Sizes
• Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - September 23, 2020
• FAQs on Testing for SARS-CoV-2 (Update)
• FAQs on Viral Transport Media During COVID-19 (Update)

September 15, 2020

• New Emergency Use Authorizations
  • cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System (Roche Molecular Systems, Inc.)
• Updated Emergency Use Authorizations
  • TRIPLEX CII-SARS-CoV-2 rRT-PCR TEST (Columbia University Laboratory of Personalized Genomic Medicine) (EUA Summary, Letter Granting EUA Revision(s))
  • Aptima SARS-CoV-2 assay (Hologic, Inc.) (HCP, Patient, IFU, Letter Granting EUA Revision(s))
• Re-Issue Emergency Use Authorizations
  • Color COVID-19 Test Unmonitored Collection Kit (Color Genomics, Inc.)
• Problems Reported with Essure - New Variance Report
• FAQs on Testing for SARS-CoV-2 (Updated)
• SARS-CoV-2 Reference Panel Comparative Data
• Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee

September 14, 2020

• Updated Emergency Use Authorizations
  • Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China
• Consumer Information on: Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System - P200015
• Recognition and Withdrawal of Voluntary Consensus Standards - Guidance for Industry and Food and Drug Administration Staff
• Webinar - Recognition and Withdrawal of Voluntary Consensus Standards - Final Guidance - October 15, 2020
• Digital Health Software Precertification (Pre-Cert) Program (Updated)
• Class I Recall: Becton Dickinson (BD) CareFusion 303, Inc. Recalls Alaris™ System PC Unit and PC Unit Front Case Keypad Replacement Kits Due to Risk of Stuck or Unresponsive Keys
• Class I Recall: Becton Dickinson (BD) CareFusion 303 Recalls Alaris System Infusion Pumps Due to Damaged Inter-Unit Interface Connectors, Loose or Missing Battery Screws and A Broken Upper and Lower Hinge Posts and Membrane Frame
• 3rd Quarter FY 2020 MDUFA IV Performance Report
• FAQs on Testing for SARS-CoV-2 (Updated)
• FAQs on Viral Transport Media During COVID-19 (Updated)
• Federal Register: Recognition and Withdrawal of Voluntary Consensus Standards

September 11, 2020

• Mammography Facility Adverse Event and Action Report - September 11, 2020: SBPH-Saint Bernard Parish Hospital/Ochsner
• Consumer Information on: VENTANA HER2 Dual ISH DNA Probe Cocktail - P190031
• EUA Authorized Serology Test Performance (Updated)
• FAQs on Testing for SARS-CoV-2 (Updated)

September 10, 2020

• New Emergency Use Authorizations
  • Wantai SARS-CoV-2 RT-PCR Kit (Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.)
  • BioCheck SARS-CoV-2 IgM Antibody Test Kit (BioCheck, Inc.)
  • BioCheck SARS-CoV-2 IgG Antibody Test Kit (BioCheck, Inc.)
• Re-issued Emergency Use Authorizations
  • KPMAS COVID-19 Test (Kaiser Permanente Mid-Atlantic States)
• Updated Emergency Use Authorizations
  • Verily COVID-19 RT-PCR Test (Verily Life Sciences) (EUA Summary)
• Presentation and Transcript added to Regulatory Overview for Developers and Sponsors of Neurological and Physical Medicine Devices: An Introduction to the De Novo Pathway Webinar
• Webinar Series - Gowns and Other Apparel for Use by Health Care Personnel in COVID-19 Pandemic - September 15, 2020
• FAQs on Testing for SARS-CoV-2 (Updated)
• FAQs on Viral Transport Media During COVID-19 (Updated)

September 9, 2020

• New Emergency Use Authorizations
  • Verily COVID-19 RT-PCR Test (Verily Life Sciences)
• Updated Emergency Use Authorizations
  • cobas SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.) (IFU)
• FAQs on Testing for SARS-CoV-2 (Updated)
• FDA Reminds Users about the Importance of Following Instructions for the Cold-Therapy Mode of Water-Circulating Hot/Cold Therapy Devices: FDA Safety Communication

September 8, 2020

• New Emergency Use Authorizations
  • qSanger-COVID-19 Assay (BillionToOne, Inc.)
• Updated Emergency Use Authorizations
  • Everlywell COVID-19 Test Home Collection Kit (Everlywell, Inc.) (EUA Summary, Letter Granting EUA Revision(s))
• FAQs on Testing for SARS-CoV-2 (Updated)
• FAQs on Viral Transport Media During COVID-19 (Updated)
• Consumer Information on: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) – P15003/S058
• Consumer Information on: ReActiv8 Implantable Neurostimulation System

September 4, 2020

• New Emergency Use Authorizations
  • cobas SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.)
  • SGTi-flex COVID-19 IgG (Sugentech, Inc.)
• Updated Emergency Use Authorizations
  • VIDAS SARS-CoV-2 IgM (bioMérieux SA) (HCP)
  • VIDAS SARS-CoV-2 IgG (bioMérieux SA) (HCP)
  • Bio-Speedy Direct RT-qPCR SARS-CoV-2 (Bioeksen R&D Technologies Ltd.) (IFU)
  • Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China
• Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff
• Meeting Materials for September 8-9, 2020 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
• Virtual Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 - October 27, 2020
• Federal Register: Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027
• FAQs on Testing for SARS-CoV-2 (Update)
• MedSun Newsletter, September 2020
• Request for Feedback: Progress Tracker for Premarket Submissions

September 3, 2020

• New Emergency Use Authorizatons
  • Bio-Speedy Direct RT-qPCR SARS-CoV-2 (Bioeksen R&D Technologies Ltd.)
• Updated Emergency Use Authorizatons
  • Appendix B: Authorized Ventilators
  • Boston Heart COVID-19 RT-PCR Test (Boston Heart Diagnostics)
• Presentation and Transcript added to Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests Webinar - August 26, 2020
• Conduct a Trial Stimulation Period Before Implanting a Spinal Cord Stimulator (SCS) - Letter to Health Care Providers
• FAQs on Testing for SARS-CoV-2 (Updated)
• Federal Register: Ophthalmic Devices Panel of the Medical Devices Advisory Committee
• Federal Register: Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health

September 2, 2020

• New Emergency Use Authorizations
  • MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit (Detectachem Inc.)
  • Kaira 2019-nCoV Detection Kit (OPTOLANE Technologies, Inc.)
  • Color COVID-19 Test Unmonitored Collection Kit (Color Genomics, Inc.)
• Updated Emergency Use Authorizations
  • U-TOP COVID-19 Detection Kit (SEASUN BIOMATERIALS) (Revision IFU, HCP, Patients; Add Letter Granting EUA Revisions)
  • Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test (Biocan Diagnostics Inc.) (IFU)
  • Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190042 added)
• August 2020 PMA Approval List
• FAQs on Testing for SARS-CoV-2 (Updated)
• FAQs on Viral Transport Media During COVID-19 (Updated)

September 1, 2020

• New Emergency Use Authorizations
  • T2SARS-CoV-2 Panel (T2 Biosystems, Inc.)
  • MiraDx SARS-CoV-2 RT-PCR assay (MiraDx)
  • SARS-CoV-2 DETECTR Reagent Kit (Mammoth Biosciences, Inc.)
  • BayCare SARS-CoV-2 RT PCR Assay (BayCare Laboratories, LLC)
  • TBG SARS-CoV-2 IgG / IgM Rapid Test Kit (TBG Biotechnology Corp.)
  • COVID-19 ELISA pan-Ig Antibody Test (University of Arizona Genetics Core for Clinical Services)
• Updated Emergency Use Authorizations
  • Ventilators and Ventilator Accessories EUAs
  • CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Clinical Research Sequencing Platform (CRSP), LLC at the
  • Broad Institute of MIT and Harvard) (Revision, HCP, Patients, EUA Summary)
  • RightSign COVID-19 IgG/IgM Rapid Test Cassette (Hangzhou Biotest Biotech Co., Ltd.) (Revision, IFU)
  • AMPIPROBE SARS-CoV-2 Test System (Enzo Life Sciences, Inc.) (IFU)
  • BioCheck SARS-CoV-2 IgG and IgM Combo Test (BioCheck, Inc.) (IFU)
• MQSA National Statistics
• FAQs on Testing for SARS-CoV-2 (Updated)
• FAQs on Viral Transport Media During COVID-19 (Updated)
• Consumer Information on: Kendall™ Multifunction Defibrillation Electrodes - P190007

August 31, 2020

• New Emergency Use Authorizations
  • PCL SARS-CoV-2 Real-Time RT-PCR Assay (Patients Choice Laboratories, LLC)
  • DxTerity SARS-CoV-2 RT PCR CE Test (DxTerity Diagnostics, Inc.)
• Updated Emergency Use Authorizations
  • SARS-CoV-2 (N gene detection) Test (Exact Sciences Laboratories) (EUA Summary, IFU, Revision)
  • Color Genomics SARS-CoV-2 RT-LAMP Diagnostic Assay (Color Genomics, Inc.) (EUA Summary, HCP, Patients, Revision)
  • Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing) (Jiangsu CoWin Biotech Co., Ltd.) (IFU)
  • SalivaDirect (Yale School of Public Health, Department of Epidemiology of Microbial Diseases) (Letter, HCP, Patients)
  • Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China
• Webinar Reminder - CDC/NIOSH's Surgical N95 Respirator Guidance - September 1, 2020
• FAQs on Testing for SARS-CoV-2 (Updated)

August 28, 2020

• New Emergency Use Authorizations
  • Cuur Diagnostics SARS-CoV-2 Molecular Assay (Cuur Diagnostics)
• Consumer Information on: Guardant360 CDx – P200010
• Webinar Series - CDC/NIOSH's Surgical N95 Respirator Guidance - September 1, 2020
• Meeting Notice: October 22, 2020 Patient Engagement Advisory Committee
• Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - September 2, 2020
• Federal Register: Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability
• FAQs on Testing for SARS-CoV-2 (Updated)
• Stop Using Gowns, including Surgical Gowns, from Laws of Motion PPE - Letter to Health Care Providers

August 27, 2020

• Presentation and Transcript added to Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests Webinar - August 19, 2020
• Presentation and Transcript added to FDA’s Surgical Masks Umbrella EUA Webinar - August 18, 2020
• Federal Register: Meetings - Patient Engagement Advisory Committee
• FAQs on Testing for SARS-CoV-2 (Updated)

August 26, 2020

• New Emergency Use Authorizations
  • Advanta Dx SARS-CoV-2 RT-PCR Assay (Fluidigm Corporation)
  • QDX SARS-CoV-2 Assay (QDx Pathology Services)
  • Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test (Biocan Diagnostics Inc.)
  • BinaxNOW COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.)
• Updated Emergency Use Authorizations
  • Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China
  • SalivaDirect (Yale School of Public Health, Department of Epidemiology of Microbial Diseases) (EUA Summary, Revision)
• FAQs on Testing for SARS-CoV-2 (Updated)
• Webinar Reminder - Regulatory Overview for Developers and Sponsors of Neurological and Physical Medicine Devices: An Introduction to the De Novo Pathway - August 27, 2020

August 25, 2020

• Updated Emergency Use Authorizatons
  • Respirator Models Removed from Appendix A (Respirator Models No Longer Authorized)
  • Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China
  • Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories
• FAQs on Testing for SARS-CoV-2 (Updated)

August 24, 2020

• New Emergency Use Authorizations
  • Guardant-19 (Guardant Health, Inc.)
  • DxTerity SARS-CoV-2 RT-PCR Test (DxTerity Diagnostics, Inc.)
  • Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay (Texas Department of State Health Services, Laboratory Services Section)
• Updated Emergency Use Authorizations
  • Quest Diagnostics PF SARS-CoV-2 Assay (Quest Diagnostics Infectious Disease, Inc.)
  • Quest Diagnostics RC SARS-CoV-2 Assay (Quest Diagnostics Infectious Disease, Inc.)
  • Quest Diagnostics HA SARS-CoV-2 Assay (Quest Diagnostics Infectious Disease, Inc.)
  • Cue COVID-19 Test (Cue Health Inc.)
  • Biomeme SARS-CoV-2 Real-Time RT-PCR Test (Biomeme, Inc.)
  • Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China
  • Illumina COVIDSeq Test (Illumina, Inc.) (IFU, Revision Letter)
  • Smart Detect SARS-CoV-2 rRT-PCR Kit (InBios International, Inc.) (IFU, Revision Letter)
  • Alinity m SARS-CoV-2 assay (Abbott Molecular Inc.) (HCP, Patients, IFU, Revision Letter)
  • Accula SARS-Cov-2 Test (Mesa Biotech Inc.) (HCP, Patients, IFU, Revision Letter)
  • Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay (Ethos Laboratories) (IFU)
• FAQs on Testing for SARS-CoV-2 (Updated)
• Pooled Sample Testing and Screening Testing for COVID-19
• Class I Recall: Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Pumps Due to Risk of Medication Delivery Error