FDA COVID-19 Update

The FDA has taken the following actions as of June 18 in the ongoing response to the COVID-19 pandemic:

• The FDA participated in the International Society for Neglected Tropical Diseases virtual meeting to discuss how the CURE ID app can be used to capture case reports regarding treatments and advance research into neglected tropical disease and COVID-19.
• Visit the FDA’s new web section Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices. This resource provides information on the Emergency Use Authorizations for COVID-19 tests and other medical devices that the FDA has issued related to COVID-19 on individual web pages to help make it easier for the public to access this information.
• Testing updates:
  • To date, FDA has authorized 141 tests under EUAs; these include 120 molecular tests, 20 antibody tests, and 1 antigen test.

Additional Resources:

• FAQs on Testing for SARS-CoV-2
• Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
• Coronavirus Disease 2019 (COVID-19)