CDRH New - September 23, 2020

CDRH New

September 23, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on September 22, 2020. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorizations
  • KimForest SARS-CoV-2 Detection Kit v1 (KimForest Enterprise Co., Ltd.)
• Updated Emergency Use Authorizations
  • Lilly SARS-CoV-2 Assay (Eli Lilly and Company)
  • SARS-CoV-2 PCR Test (Diatherix Eurofins Laboratory)
• Digital Health Center of Excellence
• Webinar - Digital Health Center of Excellence Listening Session #1 - October 19, 2020
• Webinar - Digital Health Center of Excellence Listening Session #2 - November 12, 2020
• FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products
• Network of Experts Program: Connecting the FDA with External Expertise
• FAQs on Testing for SARS-CoV-2 (Updated)
• FAQs on Viral Transport Media During COVID-19 (Updated)