Medmarc Blog (blog.medmarc.com)
Posts about
Emergency Use Authorization (EUA)
FDA Releases Two Draft Guidance Documents to Advise Manufacturers on Post COVID-19 Protocol
January
10,
2022
During the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) felt pressured to expeditiously authorize new medical devices that could protect the public. Medical equipment such as...
The PREP Act and the Revocation of an Emergency Use Authorization
July
01,
2020
In recent weeks, the FDA has revoked Emergency Use Authorizations (EUAs) for several products meant to combat COVID-19. These include the June 15, 2020 revocation [fda.gov] (download 1) of the...
FDA Moves on Home Sample Collection for COVID-19
June
11,
2020
The FDA has broken new ground on numerous occasions as a result of the COVID-19 pandemic, including with the release of a voluntary template for at-home sample collection kits under the emergency...