CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New July 13, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on July 10, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations electroCore, Inc., gammaCore Sapphire CV Updated Emergency Use Authorizations Appendix A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China Select Updates for Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions - Draft Guidance for Industry and Food and Drug Administration Staff FAQs on Testing for SARS-CoV-2 (Updated) Federal Register: Select Updates for Peripheral Vascular Atherectomy Devices - Premarket Notification Submissions