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In this section: News & Events (Medical Devices)
 * CDRHNew - News and Updates
   
   

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 3. News & Events (Medical Devices)
 4. CDRHNew - News and Updates

 1. News & Events (Medical Devices)


CDRHNEW - NEWS AND UPDATES

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JUNE 13, 2022

 * Prinatable Slides added - Webinar - Cybersecurity in Medical Devices: Quality
   System Considerations and Content of Premarket Submissions - Draft Guidance
 * Evaluation of Automatic Class III Designation (De Novo) Summaries
   (DEN200062 added)

JUNE 10, 2022

 * New Emergency Use Authroziations
   * Labcorp VirSeq SARS-CoV-2 NGS Test - Laboratory Corporation of American
     (Labcorp) 
 * Revised Emergency Use Authorizations
   * Sienna-Clarity COVID-19 Antigen Rapid Test Cassette (Salofa Oy)
 * Reissued Emergency Use Authorizations
   * Helix SARS-CoV-2 Test (Helix OpCo LLC (dba Helix))
 * In Vitro Diagnostics EUAs - Other Tests for SARS-CoV-2 (Updated)
 * Consumer Information on: GORE TAG Thoracic Branch Endoprosthesis – P210032
 * Patient and Consumer Stakeholder Discussions on MDUFA V Reauthorization
   (September 2021 - March 2022 added)

JUNE 9, 2022

 * Reissued Emergency Use Authorizations
   * Ezplex SARS-CoV-2 G Kit (SML GENETREE Co., Ltd.)
 * Class I Recall: Woodside Acquisitions Inc. Recalls Oral Rapid SARS-CoV-2
   Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits
   (Colloidal Gold) That Are Not Authorized, Cleared, or Approved by the FDA

JUNE 8, 2022

 * Revised Emergency Use Authorizations 
   * CareStart COVID-19 Antigen Home Test (Access Bio, Inc) 
 * Revoked Emergency Use Authorizations
   * ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit
     (ScienCell Research Laboratories)
 * Class I Recall: Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect

JUNE 7, 2022

 * FAQs on Testing for SARS-CoV-2 (Updated)
 * Evaluation of Automatic Class III Designation (De Novo) Summaries
   (DEN200035 added)
 * Sterilization for Medical Devices (Updated)
 * Transcript and Presentation added to Virtual Town Hall Series - Coronavirus
   (COVID-19) Test Development and Validation - June 1, 2022
 * #186, MedSun Newsletter, June 2022
 * Accreditation Bodies: How to Participate in the ASCA Pilot (Updated)
 * Testing Laboratories: How to Participate in the ASCA Pilot (Updated)
 * How to Study and Market Your Device (Information about Consensus Standards)
 * Accreditation Scheme for Conformity Assessment (ASCA) (Updated)
 * Federal Register: Cardiovascular Devices; Classification of the Intravascular
   Bleed Monitor
 * Federal Register: Safety and Effectiveness Summaries for Premarket Approval
   Applications

JUNE 6, 2022 

 * New Emergency Use Authorizations
   * DxLab COVID-19 Test (DxLab Inc.)
 * Reissued Emergency Use Authorizations
   * 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)
 * Updated Emergency Use Authorizations
   * Rapid SARS-CoV-2 Antigen Test Card (Xiamen Boson Biotech Co., Ltd)
 * Voluntary eSTAR Program (Updated)
 * Federal Register: Effects of the COVID-19 Public Health Emergency on Formal
   Meetings and User Fee Applications for Medical Devices: Questions and
   Answers; Withdrawal
 * Federal Register: Gastroenterology-Urology Devices; Classification of the
   Non-Implanted Electrical Stimulation Device for Management of Premature
   Ejaculation

JUNE 3, 2022

 * Notifications and Emergency Use Authorizations: FAQs on Testing for
   SARS-CoV-2 (Updated)
 * FAQs on Viral Transport Media During COVID-19 (Updated)
 * Consumer Information on: ENROUTE Transcarotid Stent System – P140026/S016
 * Class I Recall: Philips Respironics Recalls All V60 and V60 Plus Ventilators
   for Power Issue that May Cause Ventilator to Stop with or without Alarms
 * Electromagnetic Compatibility (EMC) of Medical Devices - Guidance for
   Industry and Food and Drug Administration Staff
 * Electromagnetic Compatibility (EMC) (Updated)
 * Federal Register: Effects of the COVID-19 Public Health Emergency on Formal
   Meetings and User Fee Applications for Medical Devices: Questions and
   Answers; Withdrawal

JUNE 2, 2022

 * UPDATE: FDA Updates Recommendations for the Use of Renuvion/J-Plasma Device
   for Certain Aesthetic Procedures: FDA Safety Communication
 * Class I Recall:  Atrium Medical Corporation Recalls iCast Covered Stent for
   Potential Balloon or Catheter Hub Separation That May Cause Patient Harm
 * Illumina Cybersecurity Vulnerability May Present Risks for Patient Results
   and Customer Networks: Letter to Health Care Providers
 * Cybersecurity (Updated)
 * 2nd Quarter FY 2022 MDUFA IV Performance Report

JUNE 1, 2022

 * New Emergency Use Authorizations
   * AdvanSure SARS-CoV-2 IgG(RBD) ELISA (LG Chem, Ltd.)
 * Reissued Emergency Use Authorizations
   * SARS-CoV-2 IgG (Abbott Laboratories Inc.)
 * Reissued and Revised Emergency Use Authorizations
   * BioFire Covid-19 Test (Biofire Defense, LLC) 
 * Revised Emergency Use Authorizations
   * UCSD EXCITE COVID-19 EL Test (UCSD BCG EXCITE Lab)
   * SCoV-2 Ag Detect Rapid Self-Test (InBios International Inc.)
   * SCoV-2 Ag Detect Rapid Test ((InBios International Inc.)
 * Updated Emergency Use Authorizations 
   * MiraDx SARS-CoV-2 RT-PCR assay (MiraDx)
   * QIAreach SARS-CoV-2 Antigen (QIAGEN GmbH)
 * MQSA National Statistics (Updated)

MAY 31, 2022

 * Consumer Information on: AccelStim Bone Growth Stimulator – P210035
 * Federal Register: Cardiovascular Devices; Classification of the Coronary
   Artery Disease Risk Indicator Using Acoustic Heart Signals

MAY 27, 2022

 * Meeting Notice: July 28-29, 2022 General and Plastic Surgery Devices Panel of
   the Medical Devices Advisory Committee
 * Class I Recall: ArjoHuntleigh Polska Recalls Sara Plus Floor Lift for Risk of
   Smoke or Fire When Lift Is Used with Depleted Battery

MAY 26, 2022

 * Class I Recall:  Abbott Medical Recalls Dragonfly OpStar Imaging Catheter for
   Potential Loose Catheter Marker Band That May Cause Patient Harm
 * Transcript and Presentation added to Virtual Town Hall Series - Coronavirus
   (COVID-19) Test Development and Validation - May 18, 2022
 * Federal Register: General and Plastic Surgery Devices Panel of the Medical
   Devices Advisory Committee
 * Federal Register: Agency Information Collection Activities; Proposals,
   Submissions, and Approvals: Postmarket Surveillance of Medical Devices

MAY 25, 2022

 * New Emergency Use Authorizations
   * AdvanSure SARS-CoV-2 IgG(S1) ELISA (LG Chem, Ltd.)
 * Reissued Emergency Use Authorizations
   * Celltrion DiaTrust COVID-19 Ag Home Test (Celltrion USA, Inc.)
 * Updated Emergency Use Authorizations
   * Atellica IM SARS-CoV-2 Antigen (CoV2Ag) (Siemens Healthcare Diagnostics,
     Inc.)
   * ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) (Siemens Healthcare Diagnostics,
     Inc.)
 * CDRH Management Directory by Organization (Updated)

MAY 24, 2022

 * CDRH Petitions (Updated)
 * Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200019,
   and DEN200072 added)
 * List of Cleared or Approved Companion Diagnostic Devices (In Vitro and
   Imaging Tools) (Updated)

MAY 23, 2022

 * Consumer Information on: Alinity m CMV Assay - P210022
 * Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA
   Safety Communication
   * Las pruebas de detección genética prenatal no invasivas pueden dar
     resultados falsos: Comunicado de seguridad de la FDA (Spanish - New)
 * Federal Register: Emergency Use Authorization: In Vitro Diagnostic Device for
   Detection and/or Diagnosis of COVID-19; Revocation

MAY 20, 2022

 * Consumer Information on: Thoraflex Hybrid - P210006
 * Virtual Public Workshop - Building Medical Device Supply Chain Resilience: A
   Healthcare and Public Health Ecosystem-Wide Collaboration (Updated)
 * Medical Devices and Radiation-Emitting Products Committee Vacancies (Updated)
 * Roster of the Radiological Devices Panel (Updated)
 * Roster of the General and Plastic Surgery Devices Panel (Updated)
 * STEM Career Opportunities at CDRH (Updated)
 * FAQs on Viral Transport Media During COVID-19 (Updated)
 * Notifications and Emergency Use Authorizations: FAQs on Testing for
   SARS-CoV-2 (Updated)

MAY 19, 2022

 * New Emergency Use Authorizations
   * Labcorp Seasonal Respiratory Virus RT-PCR Test (Laboratory Corporation of
     America (Labcorp))
   * Nexus High Throughput SARS-CoV-2 Assay (Nexus Medical Labs, LLC)
 * Reissued Emergency Use Authorizations
   * TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
   * Accula SARS-Cov-2 Test (Mesa Biotech Inc.)
   * Celltrion DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.)
 * Evaluation of Automatic Class III Designation (De Novo) Summaries
   (DEN210046 added)
 * Webinar - Cybersecurity in Medical Devices: Quality System Considerations and
   Content of Premarket Submissions - Draft Guidance - 06/14/2022
 * Ethylene Oxide Sterilization for Medical Devices (Updated)
 * Federal Register: 510(k) Sterility Change Master File Pilot Program
 * Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP
   Machines Recalled Due to Potential Health Risks: FDA Safety Communication
   (Updated)
 * FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine
   Recalls (Updated)

MAY 18, 2022

 * Evaluation of Automatic Class III Designation (De Novo) Summaries
   (DEN210044 added)
 * Transcript added to Public Meeting - Medical Device User Fee Amendments for
   Fiscal Years 2023 Through 2027 - April 19, 2022
 * Medical Device Material Safety Summaries (Updated)
 * Catalog of Regulatory Science Tools to Help Assess New Medical Devices
   (Updated)
 * Consumer Information on: Organ Care System (OCS) Heart System – P180051/S001

MAY 17, 2022

 * Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180065,
   DEN200038, and DEN210006 added)

MAY 16, 2022

 * New Emergency Use Authorizations
   * Labcorp Seasonal Respiratory Virus RT-PCR DTC Test (Laboratory Corporation
     of America (Labcorp))
 * Avanos Medical Recalls Cortrak*2 Enteral Access System for Risk of Misplaced
   Enteral Tubes Could Cause Patient Harm (Updated)
 * Class I Recall: Woodside Acquisitions Inc. Recalls Oral Rapid SARS-CoV-2
   Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits
   (Colloidal Gold) That Are Not Authorized, Cleared, or Approved by the FDA

MAY 13, 2022

 * New Emergency Use Authorizations
   * ID NOW COVID-19 2.0 (Abbott Diagnostics Scarborough, Inc.)
   * Xpert Xpress CoV-2 plus (Cepheid)
 * Revised Emergency Use Authorizations
   * INDICAID COVID-19 Rapid Antigen At-Home Test (PHASE Scientific
     International, Ltd.)
   * INDICAID COVID-19 Rapid Antigen Test (PHASE Scientific International, Ltd.)
   * CareStart COVID-19 Antigen Home Test (Access Bio, Inc.)
 * Updated Emergency Use Authorizations
   * BinaxNOW COVID-19 Ag Card Home Test (Abbott Diagnostics Scarborough, Inc.)
 * Revoked Emergency Use Authorizations
   * Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test (Quanterix
     Corporation)
   * Simoa SARS-CoV-2 N Protein Antigen Test (Quanterix Corporation)
 * Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and
   Validation (Updated)
 * Updated CDRH Learn Module: How is CDRH Structured?
 * Class I Recall: Avanos Medical Recalls Cortrak*2 Enteral Access System for
   Risk of Misplaced Enteral Tubes Could Cause Patient Harm

MAY 11, 2022

 * Consumer Information on: CardioMEMS HF System - P100045/S056
 * Transcript and Presentation added to Virtual Town Hall Series - Coronavirus
   (COVID-19) Test Development and Validation - May 4, 2022

MAY 10, 2022

 * Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA Safety
   Communication
 * Class I Recall:  SML Distribution LLC Recalls Skippack Medical Lab COVID-19
   Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by
   the FDA
 * Review Memos for Third Party 510(k) Reviewers




   CONTENT CURRENT AS OF:
   
   06/13/2022


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