CDRH New - March 30, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on March 27-29, 2020. To view listings for other dates, see CDRH New - News and Updates.

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 FAQs on Diagnostic Testing for SARS-CoV-2 (Updated) 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