CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New

October 14, 2020

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

• New Emergency Use Authorizations
  • AdviseDx SARS-CoV-2 IgM (Abbott Laboratories Inc.)
• Updated Emergency Use Authorizations
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
  • TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
  • CareStart COVID-19 Antigen test (Access Bio, Inc.)
• FAQs on Testing for SARS-CoV-2 (Updated)
• FAQs on Viral Transport Media During COVID-19 (Updated)
• Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
• Consumer Information on: LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe
• Consumer Information on: Alinity m HBV – P200013