CDRH New - March 31, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on March 30, 2020. To view listings for other dates, see CDRH New - News and Updates.

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.)