FDA COVID-19 Update

The following are some of the U.S. FDA’s actions taken, as of April 6, in its ongoing response effort to the COVID-19 pandemic:

• The FDA is leading an effort, working with government, industry and academic partners, to develop and implement a protocol that will provide convalescent plasma to patients in need across the country who may not have access to institutions with clinical trials in place. Convalescent plasma has the potential to lessen the severity or shorten the length of illness caused by COVID-19. This collaboration, involving BARDA, the American Red Cross and the Mayo Clinic, will allow for a simplified process for health care providers that will help ensure patient safety while allowing for the collection of needed information about product efficacy. The FDA anticipates that the effort will be able to move thousands of units of plasma to patients who need them in the coming weeks.

• The FDA posted an FAQ answering whether respirators approved under standards used in other countries, such as KN95s, can be used in the U.S. during the COVID-19 pandemic. The short answer is yes. In response to continued respirator shortages, the FDA also issued a new Emergency Use Authorization (EUA) for non-NIOSH-approved respirators made in China, which makes KN95 respirators eligible for authorization if certain criteria are met, including evidence demonstrating that the respirator is authentic.

• Diagnostics update to date:
  • During the COVID-19 pandemic, the FDA has worked with more than 240 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
  • To date, 28 emergency use authorizations have been issued for diagnostic tests.
  • The FDA has been notified that more than 125 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
  • The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.