CDRHNew - News and Updates

 July 30, 2021

• Materials posted for August 3, 2021 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)

July 29, 2021

• Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - July 14, 2021
• Quality and Compliance (Medical Devices) (Updated)
• UDI Exceptions, Alternatives, and Time Extensions (Updated)
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - August 4, 2021
• False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System - Letter to Clinical Laboratory Staff and Health Care Providers (Updated)
• Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions
• In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2 (Updated)
• In Vitro Diagnostics EUAs - IVDs for Management of COVID-19 Patients (Updated)
• In Vitro Diagnostics EUAs - Serology and Other Adaptive Immune Response Tests for SARS-CoV-2 (Updated)
• In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2 (Updated)

July 28, 2021

• Consumer Information on: Centaur Anti-HBe2 – P200017

July 27, 2021

• Consumer Information on: The Arctic Front Advance and Arctic Front Advance Pro and The Freezor MAX Cardiac Cryoablation Catheters – P100010/S110
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)
• Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Device Reporting

July 26, 2021

• Reissued Emergency Use Authorizations
  • Panther Fusion SARS-CoV-2 Assay (Hologic, Inc.)
  • Aptima SARS-CoV-2 assay (Aptima SARS-CoV-2 assay)
  • DetectX-Rv (PathogenDx, Inc.)
• Updated Emergency Use Authorizations
  • Simplexa COVID-19 Direct assay (DiaSorin Molecular LLC)
• Hyperbaric Oxygen Therapy: Get the Facts
• COVID-19 Update: FDA Authorizes Imported Becton Dickinson Sodium Citrate Blood Specimen (Light Blue Top) Collection Tubes

July 23, 2021

• New Emergency Use Authorizations
  • VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators (Ortho-Clinical Diagnostics, Inc.)
• Reissued Emergency Use Authorizations
  • Simplexa COVID-19 Direct assay (DiaSorin Molecular LLC)
• Revised Emergency Use Authorizations
  • CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) (Centers for Disease Control and Prevention's (CDC))
  • Linea COVID-19 Assay Kit (Applied DNA Sciences, Inc.)
• Revoked Emergency Use Authorizations
  • Gravity Diagnostics COVID-19 Assay (Gravity Diagnostics, LLC)
• Federal Register: Medical Devices: Class I Surgeon's and Patient Examination Gloves

July 22, 2021

• New Emergency Use Authorizations
  • BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site)
• Stakeholder Consultation Meetings - Medical Device User Fee Amendments 2023 (MDUFA V) (Updated)
• Federal Register: Authorization of Emergency Use of Certain Medical Devices During COVID-19
• Federal Register: Medical Devices; Exemption from Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport

July 21, 2021

• Partnerships to Advance Innovation and Regulatory Science (PAIRS) (Updated)
• Network of Experts Program: Connecting the FDA with External Expertise (Updated)
• Class I Recall: Vero Biotech Recalls GENOSYL DS; Nitric Oxide Delivery System Due to Software Error
• FDA Voices - FDA’s Budget: Medical Device Supply Chain and Shortages Prevention Program
• Neurological Devices (Updated)

July 20, 2021

• Catalog of Regulatory Science Tools to Help Assess New Medical Devices (Updated)
• 24 Hour Summary for July 14, 2021 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting
• Transcripts and Summaries for June 3-4, 2021 Neurological Devices Panel of the Medical Devices Advisory Committee Meeting

July 19, 2021

• Reissued Emergency Use Authorizations
  • PerkinsElmer New Coronavirus Nucleic Acid Detection Kit
  • ISPM Labs, LLC dbaCapstone Healthcare
• Revised Emergency Use Authorizations
  • AMPIPROBE SARS-CoV-2 Test (Enzo Life Sciences, Inc.)
  • Ambry COVID-19 RT-PCR Test (Ambry Genetics Laboratory)
  • CareSTart COVID-19 Antigen Test (Access Bio, Inc.)
• Updated Emergency Use Authorizations
  • RealStar SARS-CoV-2 RT-PCR Kits (Altona Diagnostics GmbH)
  • KimForest SARS-CoV-2 Detetion Kit v1 (KimForest Enterprise Co., Ltd.)
• Updated Emergency Use Authorizations
  • Appendix A: Authorized Surgical Masks
  • Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190043 added)

July 16, 2021

• Updated Emergency Use Authorizations
  • Appendix A: Authorized Surgical Masks
• FAQs on Viral Transport Media During COVID-19 (Updated)

July, 15, 2021

• New Emergency Use Authorizations
  • GenBody COVID-19 Ag (GenBody Inc.)
• Reissued Emergency Use Authorizations
  • Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC (Color Health, Inc.)
• Revised Emergency Use Authorizations
  • Color SARS-CoV-2 RT-LAMP Diagnostic Assay (Color Health, Inc.)
  • LIAISON SARS-CoV-2 Ag (DiaSorin, Inc.)
  • Elecsys Anti-SARS-CoV-2 (Roche Diagnostics)
  • Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette (Salofa Oy)
• Updated Emergency Use Authorizations
  • COVID-Flu Multiplex Assay (Exact Sciences Laboratories)
  • Clinical Enterprise SARS-CoV-2 RT-PCR Assay (Clinical Enterprise, Inc.)
• Historical Information about Device Emergency Use Authorizations (Updated)
• Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
• Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication (Updated)
• In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2 (Updated)
• In Vitro Diagnostics EUAs - Serology and Other Adaptive Immune Response Tests for SARS-CoV-2 (Updated)
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices - New Product Codes
• Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents (Updated)
• Potential Concerns with NuVasive MAGEC System Implants - FDA Safety Communication
• Presentations posted for July 14, 2021 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting

July 14, 2021

• CDRH Patient and Caregiver Connection (Updated)

July 13, 2021

• Updated Emergency Use Authorizations
  • Appendix A: Authorized Surgical Masks
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200039 added)
• Consumer Information on: Restylane® Contour – P140029/S032
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation (Updated)

July 12, 2021

• Updated Emergency Use Authorizations
  • NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency
• Materials posted for July 14, 2021 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting
• June 2021 PMA Approval List
• Virtual Public Workshop - Orthopedic Cartilage Repair Products - November 12, 2021
• Consumer Update: Always Tired? You May Have Sleep Apnea
• Consumer Information on: TECNIS Synergy™ Intraocular Lens (IOL) (Model ZFR00V), TECNIS Synergy™ Toric II IOL (Models ZFW150, ZFW225, ZFW300, ZFW375), TECNIS Synergy™ IOL with TECNIS Simplicity™ Delivery System (Model DFR00V), TECNIS Synergy™ Toric II IOL with TECNIS Simplicity™ Delivery System (Models DFW150, DFW225, DFW300, DFW375) – P980040/S124
• Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Device Labeling Regulations

July 9, 2021

• New Emergency Use Authorization
  • VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator (Ortho-Clinical Diagnostics, Inc.)
  • TaqPath COVID-19 RNase P Combo Kit 2.0 (Thermo Fisher Scientific Inc.)
  • ellume.lab COVID Antigen Test (Ellume Limited)
• Reissued Emergency Use Authorizations
  • Quaeris SARS-CoV-2 Assay (Harvard University Clinical Laboratory (HUCL))
• Updated Emergency Use Authorizations
  • ViroKey SARS-CoV-2 RT-PCR Test v2.0 (Vela Operations Singapore Pte. Ltd.)
  • SARS-CoV-2 DETECTR Reagent Kit (Mammoth Biosciences, Inc.)
  • cobas SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.)
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

July 8, 2021

• Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices – Letter to Health Care Providers
• Consumer Information on: Guardant360 CDx – P200010/S001

July 7, 2021

• Class I Recall: Quidel Recalls Lyra SARS-CoV-2 Assay (M120) Due to Risk of False Negative Results
• Third Party Review Organization Performance Report - FY21, Q3
• Medical Device User Fee Amendments 2023 (MDUFA V) (Updated)
• Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - June 30, 2021

July 6, 2021

• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200050 added)
• Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) - Guidance for Industry and Food and Drug Administration Staff
• UDI Rule and Guidances, Training, Resources, and Dockets (Updated)
• Contact an FDA-Accredited Issuing Agency (Updated)
• Federal Register: Guidance: Unique Device Identification System; Form and Content of the Unique Device Identifier

July 2, 2021

• New Emergency Use Authorizations
  • BioGX Xfree COVID-19 Direct RT-PCR (BioGX, Inc.)
  • COVID-Flu Multiplex Assay (Exact Sciences Laboratories)
  • Everlywell COVID-19 & Flu Test Home Collection Kit (Everlywell, Inc.)
  • BioPlex 2200 SARS-CoV-2 IgG (Bio-Rad Laboratories)
• Reissued Emergency Use Authorizations
  • Everlywell COVID-19 Test Home Collection Kit DTC (Everlywell, Inc.)
  • Assurance SARS-CoV-2 Panel DTC (Assurance Scientific Laboratories)
• Revised Emergency Use Authorizations
  • SARS-CoV-2 NGS Assay (Twist Bioscience Corporation)
  • Alinity m Resp-4-Plex (Abbott Molecular Inc.)
• Updated Emergency Use Authorizations
  • Rheonix COVID-19 MDx Assay (Rheonix, Inc.)
  • Assurance SARS-CoV-2 Panel (Assurance Scientific Laboratories)
  • Appendix A: Authorized Surgical Masks
• Consumer Information on: EPi-Sense® Guided Coagulation System – P200002
• Medtronic Vascular Recalls Angiographic Guidewire Component Due to Being Non-sterile
• MedSun Newsletter - July 2021
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19 (Updated)
• Meeting Notice: August 3, 2021 Circulatory System Devices Panel of the Medical Devices Advisory Committee

July 1, 2021

• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190023 added)
• MQSA National Statistics
• Presentation and Transcript added to Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Webinar - June 24, 2021
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - July 14, 2021
• Class I Recall: Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results
• Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - July 13, 2021
• Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee

June 30, 2021

• Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication
• Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities
• Revoked EUAs for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
• Historical Information about Device Emergency Use Authorizations (Updated)
• Personal Protective Equipment EUAs (Updated)
• FAQs on the EUAs for Non-NIOSH Approved Respirators During the COVID-19 Pandemic (Updated)
• Importing Medical Devices During the COVID-19 Pandemic (Updated)
• Considerations for Selecting Respirators for Your Health Care Facility (Updated)
• Manufacturing and Distributing Respirators for Health Care Personnel Use in the United States Under an Existing Emergency Use Authorization (EUA) During the COVID-19 Pandemic (Updated)
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180040, DEN180067, DEN190016 and DEN190026 added)
• Transcript added to Virtual Public Workshop - Orthopedic Device Postmarket Review - June 10, 2021
• New Emergency Use Authorizations
  • Tidal Medical Technologies LLC, InSee

June 29, 2021

• New Emergency Use Authorizations
  • CareStart EZ COVID-19 IgM/IgG (Access Bio, Inc.)
• Reissued Emergency Use Authorizations
  • CareStart COVID-19 IgM/IgG (Access Bio, Inc.)
• Revised Emergency Use Authorizations
  • ACON SARS-CoV-2 IgG/IgM Rapid Test (ACON Laboratories, Inc.)
  • COVID-19 Self-Collected Antibody Test System (Symbiotica, Inc.)
  • GeneFinder COVID-19 Plus RealAmp Kit (OSANG Healthcare)
  • 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
  • qSanger-COVID-19 Assay (BillionToOne, Inc.)
  • TRUPCR SARS-CoV-2 Kit (3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd.)
  • ViroKey SARS-CoV-2 RT-PCR Test (Vela Operations Singapore Pte Ltd)
  • PhoenixDx SARS-CoV-2 Multiplex (Trax Management Services Inc.)
  • Clinomics TrioDx RT-PCR COVID-19 Test (Clinomics USA Inc.)
  • Fulgent COVID-19 by RT-PCR Test (Fulgent Therapeutics)
  • cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) (Roche Molecular Systems)
• Waiver and Acknowledgment posted for July 14, 2021 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting
• Federal Register: Medical Devices-Exemption From Premarket Notification; Powered Patient Transport, All Other Powered Patient Transport: Correction
• Federal Register: MedWatch; The Food and Drug Administration Medical Products Reporting Program

June 28, 2021

• Updated Emergency Use Authorizations
  • Viracor SARS-CoV-2 assay (Viracor Eurofins Clinical Diagnostics)
  • Biomeme SARS-CoV-2 Real-Time RT-PCR Test (Biomeme, Inc.)
  • CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3) (Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard)
  • Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2