CDRH New - May 7, 2020

CDRH New May 7, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on May 6, 2020. To view listings for other dates, see CDRH New - News and Updates.

Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff Webinar - Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency - May 11, 2020 EUA Authorized Serology Test Performance (Updated EUROIMMUN SARS-COV-2 ELISA (IgG)) FAQs on Testing for SARS-CoV-2 (Updated)