CDRHNew - News and Updates
September 2, 2022
September 1, 2022
- At-Home OTC COVID-19 Diagnostic Tests (Extended Expiration Dates for OHC COVID-19 Antigen Self Test and CareStart COVID-19 Antigen Home Test)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210052 added)
- MQSA National Statistics (Updated)
August 31, 2022
- Class I Recall: Integra Recalls CereLink ICP Monitor for Risk of Incorrect Intracranial Pressure Readings
- MedSun Newsletter, September 2022 (PDF - 4MB)
August 30, 2022
- Revised Emergency Use Authorizations
- Elecsys Anti-SARS-CoV-2 S (Roche Diagnostics, Inc. )
- CareStart COVID-19 Antigen Home Test (Access Bio, Inc.)
- Genabio COVID-19 Rapid Self-Test Kit (Genabio Diagnostics Inc.)
- NIDS COVID-19 Antigen Rapid Test Kit (ANP Technologies, Inc.)
- BioCode CoV-2 Flu Plus Assay (Applied BioCode, Inc.)
- MicroGEM Sal6830 SARS-CoV-2 Saliva Test (MicroGEM U.S., Inc.)
- Revoked Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Transcript for: July 12-13, 2022 Patient Engagement Advisory Committee Meeting
- Transcript for: July 28-29, 2022 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
August 29, 2022
- Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication
- Class I Recall: Intera Oncology Recalls Intera 3000 Hepatic Artery Infusion Pump Due to Faster Than Expected Flow Rates That May Impact Infusion Delivery
- Class I Recall: Hamilton Medical AG Recalls Hamilton-C6 Intensive Care Ventilator Due to Potential Water Ingress that May Cause Breathing Support to Stop
August 26, 2022
- Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
- 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic (Updated)
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
August 25, 2022
- Call I Recall: Medtronic Recalls HeartWare HVAD System Batteries for Electrical Faults That Cause Battery Failure
- Consumer Information on: Stellarex 0.035 OTW Drug-coated Angioplasty Ballon - P160049/S015
- Medtronic HeartWare Ventricular Assist Device (HVAD) System (Updated)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200039 added)
- Transcripts for:
- Virtual Public Workshop – Study Design Considerations for Transbronchoscopic Thermal Ablation Devices for the Treatment of Oligometastases to the Lung
- Virtual Public Workshop – Animal Studies for Orthopedic Products - 06/02/2022
- Virtual Public Workshop - Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration - 06/07/2022
- Federal Register: Authorization and Revocations of Emergency Use of Certain In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19
August 24, 2022
- List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Export of Medical Devices; Foreign Letters of Approval
August 23, 2022
- Consumer Information on: BioFreedom Drug Coated Coronary Stent (DCS) System – P190020
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Device Labeling Regulations
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Devices; Humanitarian Use Devices
August 22, 2022
- Reissued Emergency Use Authorization
- Revised Emergency Use Authorizations
- EUA Authorized Serology Test Performance (Updated)
- eMDR
August 19, 2022
- Class I Recall: Medtronic Recalls Cobalt XT, Cobalt and Crome ICDs and CRT-Ds for Risk that Devices May Issue a Short Circuit Alert and Deliver Reduced Energy Shock During High Voltage Therapy
- At-Home OTC COVID-19 Diagnostic Tests (Extended Expiration Dates for Lucira CHECK-IT COVID-19 Test Kit and InteliSwab COVID-19 Rapid Test)
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Center for Devices and Radiological Health Appeals Processes
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Current Good Manufacturing Practice; Quality System Regulation
August 17, 2022
August 16, 2022
- Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - Guidance for Industry and Food and Drug Administration Staff
- Information on Hearing Aids (Updated)
- Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff
- Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices - Guidance for Industry and FDA Staff
- Consumer Information on: JUVÉDERM VOLUX XC - P110033/S065
- 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)
- Federal Register: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Guidance for Industry and Food and Drug Administration Staff; Availability
- Federal Register: Medical Devices: Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
August 15, 2022
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- cobas SARS-COV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) (Roche Molecular Systems, Inc.)
- cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System (Roche Molecular Systems, Inc.)
- Celltrion DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.)
- INDICAID COVID-19 Rapid Antigen Test (PHASE Scientific International, Ltd.)
- INDICAID COVID-19 Rapid Antigen At-Home Test (PHASE Scientific International, Ltd.)
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
August 5, 2022
- Updated Emergency Use Authorizations
- 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
- 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
- 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
- Reissued Emergency Use Authorizations
- 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
- 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)