CDRHNew - News and Updates
January 22, 2021
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- FAQs for Filtering Facepiece Respirator (FFR) Decontamination Systems
- PPE Webinar Use of Dry Heat to Support Single-User Reuse of Certain Respirators - January 26, 2021
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 27, 2021
- Webinar - Safer Technologies Program: Final Guidance - February 1, 2021
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - February 3, 10, 17, and 24, 2021
- Third Party Review Organization Performance Report for FY2021 Q1
- Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
January 21, 2021
- New Emergency Use Authorizations
- Reissued Emergency Use Authorization
- Updated Emergency Use Authorizations
- Recognized Consensus Standards Database (Updated)
- Post-Approval Studies Program (Updated)
- 522 Postmarket Surveillance Studies Program (Updated)
- Mammography Facility Adverse Event and Action Report - January 21, 2021: Ochiltree County Hospital District
- 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)
January 19, 2021
- New Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Consumer Information on: Alinity m HCV - P190025
- Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 13, 2021
- Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - January 26, 2021
January 15, 2021
- Updated Emergency Use Authorizations
- Summary Minutes for November 6-7, 2019 General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee Meeting
- Transcripts for September 8-9, 2020 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting
- Summary Minutes for September 8-9, 2020 Orthopaedic and Rehabilitation 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)
- FAQs on Viral Transport Media During COVID-19 (Updated)
January 14, 2021
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
- 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)
- Summary Minutes for Nov. 14, 2019 Immunology Devices Panel Meeting
- Federal Register: Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices from Premarket Notification Requirements; Request for Information, Research, Analysis, and Public Comment on Opportunities for Further Science and Evidence-Based Reform of Section 510(k) Program
January 13, 2021
- Updated Emergency Use Authorization
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Meeting Notice: February 17, 2021 Circulatory System Devices Panel of the Medical Devices Advisory Committee
- Catalog of Regulatory Science Tools to Help Assess New Medical Devices (Updated)
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 27, 2021
- Mammography: What You Need to Know (Updated)
- Breast Cancer Screening: Thermogram No Substitute for Mammogram (Updated)
- What to Know About Breast Implants (Updated)
- December 2020 PMA Approval List
January 12, 2021
- New Emergency Use Authorizations
- Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 6, 2021
- Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan
- FDA News Release: FDA Releases Artificial Intelligence/Machine Learning Action Plan
- 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)
- Federal Register: Meetings: Circulatory System Devices Panel of the Medical Devices Advisory Committee
January 11, 2021
- New Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Problems Reported with Essure (Updated)
- 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 (Update)
January 8, 2021
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- EUA Authorized Serology Test Performance (Updated)
- Consumer Information on: ActaStim-S Spine Fusion Stimulator - P190030
- Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers
- FDA News Release: FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- FAQs on Viral Transport Media During COVID-19 (Updated)
January 7, 2021
- New Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Accreditation Scheme for Conformity Assessment (ASCA) (Updated)
- 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 (Update)
- Federal Register: Requests for Nominations: National Mammography Quality Assurance Advisory Committee
January 6, 2021
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 13, 2021
January 5, 2021
- Safer Technologies Program for Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Guidance for Industry and Food and Drug Administration Staff
- Webinar - Safer Technologies Program: Final Guidance
- Safer Technologies Program (SteP) for Medical Devices
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- FAQs on Viral Transport Media During COVID-19 (Updated)
- Federal Register: Guidance: Safer Technologies Program for Medical Devices
January 4, 2021
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- MQSA National Statistics
- Mouse Embryo Assay for Assisted Reproduction Technology Devices - Guidance for Industry and Food and Drug Administration Staff
- Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication
- Federal Register: Guidance: Mouse Embryo Assay for Assisted Reproduction Technology Devices
- 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)
December 31, 2020
December 30, 2020
- Updated Emergency Use Authorizations
December 29, 2020
- Product Labeling for Laparoscopic Power Morcellators - Guidance for Industry and Food and Drug Administration Staff
- UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication
- Laparoscopic Power Morcellators (Updated)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190035 and DEN200016 added)
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 6, 2021
- COVID-19 Tests and Collection Kits Authorized by the FDA in 2020: Infographic
- Center for Devices and Radiological Health's Response to Coronavirus (COVID-19): Infographic (Updated)
- 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)
- Federal Register: Requests for Nominations: Technical Electronic Product Radiation Safety Standards Committee; Voting Members
- Federal Register: Guidance: Product Labeling for Laparoscopic Power Morcellators
December 28, 2020
- New Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
December 23, 2020
- New Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Supplies of Medical Devices for COVID-19: Frequently Asked Questions
- Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
- Medical Device Types to Help Determine Section 506J Notification Obligations (Updated)
- 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)
- FAQs on Viral Transport Media During COVID-19 (Updated)
- Class I Recall: Cook Medical Recalls Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers Due to Separation in Device
- Consumer Information posted for MiniMed 770G System - P160017/S076
December 22, 2020
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- QuickVue SARS Antigen Test (Quidel Corporation)
- Verily COVID-19 RT-PCR Test (Verily Life Sciences)
- TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
- BioFire Respiratory Panel 2.1 (RP2.1) (BioFire Diagnostics, LLC)
- Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
- FAQs on Viral Transport Media During COVID-19 (Updated)
- Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers (Revised) - Guidance for Industry and Food and Drug Administration Staff
- Presentation and Transcript posted for Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - December 16, 2020
December 21, 2020
- New Emergency Use Authorizations
- Updated Emergency Use Authorizations