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

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FDA updates EUA for convalescent plasma, guidance on preventing medical device shortages
tjordan_drupal
Dec 3, 2020

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.
 

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FDA updates EUA for convalescent plasma, guidance on preventing medical device shortages
tjordan_drupal
Dec 3, 2020

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.
 

Novel Coronavirus (SARS-CoV-2/COVID-19)
COVID-19: CDC, FDA and CMS Guidance

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