CDRH New - May 8, 2020

CDRH New May 8, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on May 7, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations OPTI Medical Systems, Inc. Sherlock BioSciences, Inc. BioMerieux SA Duke Decontamination System Updated Emergency Use Authorizations BioFire Respiratory Panel 2.1 AIT Laboratories - Appendix A Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection - Letter to Health Care Providers FAQs on Shortages of Surgical Masks and Gowns During the COVID-19 Pandemic (Updated) FAQs on the EUAs for Non-NIOSH Approved Respirators During the COVID-19 Pandemic (Updated) Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization - Letter to Health Care Providers FAQs on Testing for SARS-CoV-2 (Updated) Presentation and Transcript added to: Webinar - 510(k) Third Party Review Program: Final Guidance - April 16, 2020 Presentation and Transcript added to: Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - April 29, 2020