CDRHNew - News and Updates
April 1, 2020
- Meeting Notice: June 9, 2020 Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
- FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data
- FAQs on Diagnostic Testing for SARS-CoV-2 (Updated)
March 31, 2020
- Emergency Use Authorizations – Added Yale New Haven Hospital, Clinical Virology Laboratory
- Federal Register: Ophthalmic Devices Panel of the Medical Devices Advisory Committee
March 30, 2020
- FAQs on Diagnostic Testing for SARS-CoV-2 (Updated)
- Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
- Class I Recall: Medtronic Recalls Pipeline Flex Embolization Devices Due to Risk of Device Fracture
- Class I Recall: CME America Recalls BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion
- Webcast Archive posted for Public Workshop - Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine, March 5, 2020
- Presentation posted for the March 25, 2020 Virtual Town Hall Series on the Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
- Emergency Use Authorizations - Added QIAstat-Dx Respiratory SARS-CoV-2 Panel (QIAGEN GmbH), and NeuMoDx SARS-CoV-2 Assay (NeuMoDx Molecular, Inc.)
March 29, 2020
- Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
- Emergency Use Authorizations - Added Battelle Decontamination System
March 28, 2020
March 27, 2020
- Emergency Use Authorizations - Added ID NOW COVID-19, NxTAG CoV Extended Panel Assay, and Letters Granting EUA Amendment(s) to Quest SARS-CoV-2 rRT-PCR and Simplexa COVID-19 Direct assay
- Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A - Guidance for Industry and Food and Drug Administration Staff
- Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - April 1, 2020
- Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 053
March 26, 2020
- FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic
- Digital Health Policies and Public Health Solutions for COVID-19
- Public Workshop - Artificial Intelligence in Radiological Imaging: Extension of Comment Period
- Emergency Use Authorizations - Added Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV
March 25, 2020
- Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
- Emergency Use Authorizations - Added Ventilators and AvellinoCoV2 test
March 24, 2020
- Emergency Use Authorizations - Added Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators and PerkinElmer New Coronavirus Nucleic Acid Detection Kit
- FAQs on Diagnostic Testing for SARS-CoV-2 (Updated)
- FDA Statement: Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers
March 23, 2020
- Letter to Industry on COVID-19
- FAQs on Diagnostic Testing for SARS-CoV-2 (Updated)
- Emergency Use Authorizations - Accula SARS-Cov-2 Test (Mesa Biotech Inc.) and BioFire COVID-19 Test (BioFire Defense, LLC)
- Consumer Information on: Abbott InfinityTM DBS Neurostimulation System - P140009/S039
March 22, 2020
- Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
- Ventilator Supply Mitigation Strategies - Letter to Health Care Providers
March 21, 2020
- FAQs on Diagnostic Testing for SARS-CoV-2 (Updated)
- Emergency Use Authorizations - Added Xpert Xpress SARS-CoV-2 test (Cepheid)
March 20, 2020
- Emergency Use Authorizations - Added Primerdesign Ltd COVID-19 genesig Real-Time PCR assay (Primerdesign Ltd)
- Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19 ) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
- News Release: Coronavirus (COVID-19) Update: FDA allows expanded use of devices to monitor patients’ vital signs remotely
- Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - March 25, 2020
- FAQs on Shortages of Medical Gloves
- Medical Glove Conservation Strategies: Letter to Health Care Providers
- FAQs on Diagnostic Testing for SARS-CoV-2 (Updated)
March 19, 2020
- Emergency Use Authorizations - Added ePlex SARS-CoV-2 Test (GenMark Diagnostics, Inc.) and Simplexa COVID-19 Direct (DiaSorin Molecular LLC)
- MQSA Inspection Information Related to COVID-19
- POSTPONED: Public Workshop - Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond - March 31, 2020
March 18, 2020
- Emergency Use Authorizations - Added Abbott RealTime SARS-CoV-2 assay (Abbott Molecular)
- Consumer Information on: LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs, LIAISON® XL MUREX Anti-HBs Verifiers - P180039
- Class I Recall: CME America Recalls BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System Due to Risk of Under-Infusion
March 17, 2020
- Emergency Use Authorizations - Added Quest SARS-CoV-2 rRT-PCR (Quest Diagnostics Infectious Disease, Inc.) and Lyra SARS-CoV-2 Assay (Quidel Corp.)
- FAQs on Diagnostic Testing for SARS-CoV-2 (Updated)
- POSTPONED: April 16, 2020 Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting
March 16, 2020
- Emergency Use Authorizations - Added COVID-19 RT-PCR Test (Laboratory Corporation of America) and Panther Fusion SARS-CoV-2 (Hologic, Inc.)
- Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff
- MQSA Facility Adverse Event and Action Report - March 13, 2020: The Breast Institute at JFK Medical Center North Campus
March 13, 2020
- POSTPONED: April 16, 2020 Circulatory System Devices Panel of the Medical Devices Advisory Committee
- Updated: FAQs on Diagnostic Testing for SARS-CoV-2
- Presentation added to Webinar - Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency - March 2, 2020
- Emergency Use Authorizations - Added TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
March 12, 2020
- Emergency Use Authorizations - Added cobas SARS-CoV-2 (Roche Molecular Systems, Inc.)
- Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee
- Updated: FAQs on Diagnostic Testing for SARS-CoV-2
- Consumer Information on: AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (IOL) (Model DFT015), AcrySof™ IQ Vivity™ Toric Extended Vision IOLs (DFT315, DFT415, DFT515), AcrySof™ IQ Vivity™ Extended Vision UV Absorbing IOL (DAT015), and AcrySof™ IQ Vivity™ Toric Extended Vision UV Absorbing IOLs (DAT315, DAT415, DAT515) - P930014/S126
March 11, 2020
- 510(k) Third Party Review Program - Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations
- Webinar - 510(k) Third Party Review Program: Final Guidance - April 16, 2020
- Surgical Mask and Gown Conservation Strategies - Letter to Healthcare Providers
- FAQs on Shortages of Surgical Masks and Gowns
- Federal Register: The 510(k) Third Party Review Program
March 10, 2020
- Updated: FAQs on Diagnostic Testing for SARS-CoV-2
- Updated with Four New Modules: CDRH Learn Course List (Spanish)
March 9, 2020
- Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery - Guidance for Industry and Food and Drug Administration Staff
- Updated: FAQs on Diagnostic Testing for SARS-CoV-2
March 6, 2020
- Class I Recall: Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris System Infusion Pumps Due to Software and System Errors
- Transcript added to: Webinar - Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency - March 2, 2020
- Emergency Use Authorizations: Authorized NIOSH-approved Respirators that have been held Beyond their Manufacturer-intended Shelf Life or Expiration Date
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Food and Drug Administration Safety Communication Readership Survey
March 5, 2020
- Virtual Town Hall - Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency - Immediately in Effect Guidance - March 6, 2020
- Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 - April 7, 2020
- Federal Register: Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027
- Federal Register: Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing Under the Clinical Laboratory Improvement Amendments Prior to Emergency Use Authorization for Coronavirus Disease-2019 During the Public Health Emergency; Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff; Availability
March 4, 2020
- Updated: Medical Device Bans
- FDA News Release: FDA Takes Rare Step to Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
- Federal Register: Banned Devices: Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
March 3, 2020
- N95 Respirators and Surgical Masks (Face Masks)
- Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway - Draft Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Soft (Hydrophilic) Daily Wear Contact Lenses--Performance Criteria for Safety and Performance Based Pathway
- SweynTooth Cybersecurity Vulnerabilities May Affect Certain Medical Devices: FDA Safety Communication
- FDA News Release: FDA Informs Patients, Providers and Manufacturers About Potential Cybersecurity Vulnerabilities in Certain Medical Devices with Bluetooth Low Energy
March 2, 2020
- Emergency Use Authorizations - NIOSH-Approved Disposable Filtering Facepiece Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency
- Bone Anchors - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff
- MQSA National Statistics
- Presentations added to Workshop - Evolving Role of Artificial Intelligence in Radiological Imaging - February 25-26, 2020
- Federal Register: Bone Anchors--Premarket Notification (510(k)) Submissions
February 29, 2020
- Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency - Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff
- Accelerated Emergency Use Authorization Template for SARS-COV-2 (covid-19) Molecular Testing of Respiratory Specimens in CLIA Certified High-Complexity Laboratories (Word - 128kb)
- Webinar - Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency - March 2, 2020
- Emergency Use Authorizations - New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel (Wadsworth Center, NYSDOH)
February 27, 2020
- Class I Recall: King Systems Recalls King Vision Video Laryngoscope Adapter Size ½ Due to a Display of The Reversed Image
- Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication
- Press Release: FDA Reminds Patients that Devices Claiming to Clean, Disinfect or Sanitize CPAP Machines Using Ozone Gas or UV Light Have Not Been FDA Authorized
February 26, 2020
- The FDA Announces Voluntary eSTAR Pilot Program to Streamline 510(k) Preparation and Review
- FDA In Brief: FDA launches new interactive, PDF-based, template to promote greater efficiency and consistency in preparation and review of 510(k) medical device applications
- Federal Register: Improving 510(k) Submission Preparation and Review: Voluntary Electronic Submission Template and Resource Pilot Program
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190020 added)
February 25, 2020
- UPDATE: Reduce the Risk of Cardiac Surgery Infection While Using the LivaNova Heater-Cooler System 3T: FDA Safety Communication
- Class I Recall - Tytek Medical Recalls TM-317 PneumoDart-Pneumothorax Needle Due to Fully and Partially Blocked Needles
- Product Labeling for Laparoscopic Power Morcellators - Draft Guidance for Industry and Food and Drug Administration Staff
- Recommendations for Dual 510(k) and CLIA Waiver by Application Studies - Guidance for Industry and Food and Drug Administration Staff
- Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff
- Webinar - Clinical Laboratory Improvement Amendments (CLIA) Waiver Applications Final Guidances - April 14, 2020
- Updated: Clinical Laboratory Improvement Amendments (CLIA)
- UPDATE: The FDA recommends performing contained morcellation in women when laparoscopic power morcellation is appropriate
- Federal Register: Product Labeling for Laparoscopic Power Morcellators
- Federal Register: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
- Federal Register: Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies
- Press Release: FDA Takes New Steps to Increase the Safety of Laparoscopic Power Morcellators when used in Gynecologic Surgeries