CDRHNew - News and Updates

August 11, 2022

• At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication
• Becton Dickinson Recalls Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, and Intraosseous Powered Drivers for Issues That May Cause Delayed Treatment Delivery
• Consumer Information on: SBL-3 Multifocal Intraocular Lens - P200020
• Consumer Information on: ADVIA Centaur HBc Total 2 (HBcT2), ADVIA Centaur HBc Total 2 Quality Control (HBcT2 QC), Atellica IM HBc Total 2 (HBcT2), Atellica IM HBc Total 2 Quality Control (HBcT2 QC) - P210019
• Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Agreement for Shipment of Devices for Sterilization
• Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Device Accessories

August 10, 2022

• Color Additives for Medical Devices (Updated)

August 9, 2022

• Evaluation of Automatic Class III Designation (De Novo) Summaries (Added DEN190039 and DEN200030)
• Federal Register: Mammography Quality Standards Act Requirements
• Federal Register: Food and Drug Administration Modernization Act: Modifications to the List of Recognized Standards, Recognition List Number: 058
• Haimen Shengbang Laboratory Equipment Co. Ltd. Recalls Viral Transport Media Containers That Are Not Authorized, Cleared, or Approved by the FDA

August 8, 2022

• Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Q-Submission Program for Medical Devices

August 5, 2022

• Updated Emergency Use Authorizations
  • CLINITEST Rapid COVID-19 Antigen Self-Test (Siemens Healthineer)
• Mammography Facility Adverse Event and Action Report - August 5, 2022: Elliott Breast Clinic
• Mammography Facility Adverse Event and Action Report - August 5, 2022: Watson Imaging Center

August 4, 2022

• Revised Emergency Use Authorizations
  • DASH SARS-CoV-2/S Test (Minute Molecular Diagnostics, Inc.)
• Breast Implants (Updated)
• Things to Consider Before Getting Breast Implants (Updated)
• Medical Device Reports for Systemic Symptoms in Women with Breast Implants (Updated)
• Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma (Updated)
• Breast Implants: Additional Resources (Updated)
• CDRH’s Experiential Learning Program - Submission Period Now Open

August 3, 2022

• Revised Emergency Use Authorizations
  • COVID-Flu Multiplex Assay (Exact Sciences Laboratories)
  • UOL COVID-19 Test (Uh-Oh Labs Inc.)
  • InteliSwab COVID-19 Rapid Test (OraSure Technologies, Inc.)
  • InteliSwab COVID-19 Rapid Test Rx (OraSure Technologies, Inc.)
  • InteliSwab COVID-19 Rapid Test Pro (OraSure Technologies, Inc.)
• SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Twist Bioscience)
• In Vitro Diagnostics EUAs - Other Tests for SARS-CoV-2 (Twist Biosciences)
• Sterilization for Medical Devices (Updated)
• Transcript and Presentation: Coronavirus (COVID-19) Test Development and Validation Virtual Town Hall Series  - July 27, 2022
• Breakthrough Devices Program (Updated)

August 2, 2022

• New Emergency Use Authorizations
  • Helix Diagnostics SARS nCoV-2019 Multiplexed Assay (Helix Diagnostics)
• Reissued Emergency Use Authorizations
  • SARS-CoV-2 NGS Assay (Twist Bioscience Corporation)
• MedSun Newsletter: August 2022, Volume 22, Issue 8
• MaximBio ClearDetect COVID-19 Antigen Home Test (Extended Expiration Date)
• Pruebas de COVID-19 sin receta médica o de venta libre para diagnóstico en el hogar: MaximBio ClearDetect COVID-19 Antigen Home Test (Extended Expiration Date)

August 1, 2022

• Revoked Emergency Use Authorizations
  • BD SARS-CoV-2/Flu for BD MAX System (Becton Dickenson and Company (BD))
• Consumer Information on: TactiCath Contact Force Ablation Catheter, Sensor Enabled - P130026/S070
• Class I Recall: North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits That Are Not Authorized, Cleared, or Approved by the FDA
• MQSA National Statistics (Updated)

July 29, 2022

• Reissued Emergency Use Authorizations
  • Predicine SARS-CoV-2 RT-PCR Test (Predicine, Inc.)
  • Revogene SARS-CoV-2 (Meridian Bioscience, Inc.)
  • Omnia SARS-CoV-2 Antigen Test (Qorvo Biotechnologies, LLC.: For Qorvo Biotechnologies, LLC.)
• Revised Emergency Use Authorizations
  • Labcorp Seasonal Respiratory Virus RT-PCR Test (Laboratory Corporation of America (Labcorp))
  • Labcorp Seasonal Respiratory Virus RT-PCR DTC Test (Laboratory Corporation of America (Labcorp))
  • Labcorp SARS-CoV-2 & Influenza A/B Assay (Laboratory Corporation of America (Labcorp))
  • Lucira CHECK-IT COVID-19 Test Kit (Lucira Health, Inc.)
  • Lucira COVID-19 All-In-One Test Kit (Lucira Health, Inc.)

July 28, 2022

• Class I Recall: Covidien, LLC (Medtronic) Recalls Palindrome and Mahurkar Hemodialysis Catheters Due to Catheter Hub Defect
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210032 added)

July 27, 2022

• Laser-Assisted In Situ Keratomileusis (LASIK) Lasers - Patient Labeling Recommendations - Draft Guidance for Industry and Food and Drug Administration Staff
• Updated CDRH Learn Module: How to Get Your Electronic Product on the U.S. Market
• Federal Register: Laser-Assisted In Situ Keratomileusis Lasers: Patient Labeling Recommendations

July 26, 2022

• Meeting materials for July 28-29, 2022 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting 
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

July 25, 2022

• Reissued Emergency Use Authorizations
  • Visby Medical COVID-19 Point of Care Test (Visby Medical, Inc.)
  • LumiraDx SARS-CoV-2 Ag Test (LumiraDx UK Ltd.)
• Revised Emergency Use Authorizations
  • Color COVID-19 Self-Swab Collection Kit (Color Health)
  • PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 (PerkinElmer, Inc)
  • Nexus High Throughput SARS-CoV-2 Assay (Nexus Medical Labs, LLC)
  • QuickVue At-Home OTC COVID-19 Test (Quidel Corporation)
  • MaximBio ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.)
  • T-Detect COVID Test - (Adaptive Biotechnologies Corporation)
• Updated Emergency Use Authorizations
  • Flowflex COVID-19 Antigen Home Test (ACON Laboratories, Inc)
  • Innovita 2019-nCoV Ab Test (Colloidal Gold) - (Innovita (Tangshan) Biological Technology Co., Ltd.)

July 22, 2022

• Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices - Guidance for Industry and Food and Drug Administration Staff
• Co-sponsored Public Workshop - Expediting Innovation of Bioelectronic Implants for Vision Restoration, October 24-25, 2022
• Federal Register: Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices

July 21, 2022

• New Emergency Use Authorizations
  • Predicine SARS-CoV-2 RT-PCR Test (Predicine, Inc.)
• Reissued Emergency Use Authorizations
  • HealthPulse@home (Audere)
• Revoked Emergency Use Authorizations
  • 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 Test STS Lab Holdco (a subsidiary of Amazon.com Services LLC))
  • Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test (STS Lab Holdco (a subsidiary of Amazon.com Services LLC))
• Federal Register: Emergency Use Authorization: Certain Medical Devices during COVID-19
• Do Not Use Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation: FDA Safety Communication

July 20, 2022

• iHealth Labs, Inc.: iHealth COVID-19 Antigen Rapid Test (Updated Expiration Date)
• Class I Recall: Smiths Medical Recalls Certain Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Issues That May Impact Infusion Delivery
• 24 Hour Summary for July 12-13, 2022 Patient Engagement Advisory Committee Meeting
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200035 added)

July 19, 2022

• Supplies of Medical Devices for COVID-19: Frequently Asked Questions (Updated)
• Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
• Medical Device Types to Help Determine Section 506J Notification Obligations (Updated)
• Medical Gowns (Updated)
• Pruebas de COVID-19 sin receta médica o de venta libre para diagnóstico en el hogar (Updated)
• At-Home OTC COVID-19 Diagnostic Tests (SD Biosensor updated)

July 18, 2022

• Reissued Emergency Use Authorizations
  • Helix SARS-CoV-2 Test (Helix OpCo LLC (dba Helix))
• Revised Emergency Use AUthorizations
  • BD SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson and Company (BD))
• Updated Emergency Use Authorizations
  • Bio-Speedy Direct RT-qPCR SARS-CoV-2 (Bioeksen R&D Technologies Inc.)
  • VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Calibrator (Ortho-Clinical Diagnostics, Inc.)
• Tracking Your Premarket Submission’s Progress (Progress Tracker) (Updated)

July 15, 2022

• Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety Communication
• CDRH Petitions (Updated)
• Presentations for July 12-13, 2022 Patient Engagement Advisory Committee Meeting

July 14, 2022

• SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)
• Class I Recall: American Contract Systems Recalls COVID Test Kits Nonsterile and Clean Catch Urine Kits for Risk of False Results
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210045 added)

July 13, 2022

• Revised Emergency Use Authorizations
  • iHealth COVID-19 Antigen Rapid Test (iHealth Labs, Inc.)

July 12, 2022

• New Emergency Use Authorization
  • Speedy Swab Rapid COVID-19 Antigen Self-Test (Watmind USA)
  • Genabio COVID-19 Rapid Self-Test Kit (Genabio Diagnostics Inc.)

July 11, 2022

• Reissued Emergency Use Authorizations
  • Rheonix COVID-19 MDx Assay (Rheonix, Inc.)
• Revised Emergency Use Authorizations
  • Pixel by Labcorp COVID-19 Test Home Collection Kit (Laboratory Corporation of America (LabCorp))
  • Quest COVID-19 PCR Test Home Collection Kit (Quest Diagnostics Nichols Institute)
• Updated Emergency Use Authorizations
  • SalivaDirect At-Home Collection Kit (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
  • SalivaDirect DTC Saliva Collection Kit (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
  • Procleix SARS-CoV-2 Assay (Grifols Diagnostic Solutions, Inc.)
  • Abbott RealTime SARS-CoV-2 (Abbott Molecular Inc.)