FDA updates EUA for convalescent plasma, guidance on preventing medical device shortages

The FDA this week revised and reissued its August emergency use authorization for COVID-19 convalescent plasma to treat hospitalized patients with COVID-19. The revised EUA adds the Mount Sinai COVID-19 ELISA IgG Antibody Test as an acceptable test for qualifying high and low titer COVID-19 convalescent plasma.

FDA also has updated its guidance implementing section 3121 of the Coronavirus Aid, Relief, and Economic Security Act, which requires manufacturers to notify FDA of a permanent discontinuance or significant interruption in the manufacture of certain medical devices to prevent or mitigate shortages during the COVID-19 emergency. FDA said the update aims to clarify and help manufacturers provide the agency with timely and informative notifications.