Medmarc Blog (blog.medmarc.com)
PREP Act
FDA Releases Two Draft Guidance Documents to Advise Manufacturers on Post COVID-19 Protocol
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...
HHS Orders FDA to Stand Down on LDTs
The Department of Health and Human Services issued an Aug. 19 rescission order to the FDA directing the agency to cease requiring any premarket reviews for lab-developed tests (LDTs), a change...
The PREP Act and the Revocation of an Emergency Use Authorization
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...
An Overview of Liability Immunity for Products Meant to Counter COVID-19 Under the PREP Act
Device manufacturers (as well as drug manufacturers, distributors, and health care providers) are struggling to answer many questions regarding their potential products liability in responding...