CDRHNew - News and Updates
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Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff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)
July 29, 2022
- Reissued Emergency Use Authorizations
- 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
- 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
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
- Reissued Emergency Use Authorizations
- 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
- Revised Emergency Use AUthorizations
- Updated Emergency Use Authorizations
- Tracking Your Premarket Submission’s Progress (Progress Tracker) (Updated)