CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New June 2, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on June 1, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorization Abiomed, Inc., Impella RP System Updated Emergency Use Authorizations Appendix B: Ventilator EUA Appendix B Listing Abbott Diagnostics Scarborough, Inc. ID NOW COVID-19 Becton, Dickinson & Company (BD) BioGX SARS-CoV-2 Reagents for BD MAX System OPTI Medical Systems, Inc. OPTI SARS-CoV-2 RT PCR Test Appendix A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China FAQs on Testing for SARS-CoV-2 (Updated) Class I Recall: Medtronic recalls StealthStation auto-registration feature due to inaccuracies during deep brain stimulation (DBS) procedures MQSA National Statistics