In July and August of 2021, the Food and Drug Administration (FDA) announced the revocation of the Emergency Use Authorizations (EUAs) for Gravity Diagnostics, LLC for the Gravity Diagnostics COVID-19 Assay, Materials and Machines Corporation of America for the MatMaCorp COVID-19 2SF Test, and Guardant Health Inc. for the Guardant-19. On September 24, 2021, the official Notice of Action (NOA) was published on the Federal Register detailing these revocations.
In light of the pandemic of 2020 FDA authorized the use of EUAs under Section 564 of the Food Drug & Cosmetic Act (FD&C) to help protect the public more quickly and efficiently. EUAs allow FDA to authorize certain unapproved medical devices and products in specific scenarios, such as COVID-19. The issuance of these EUAs must be revoked when the criteria under which the original EUA was granted no longer holds. Now that the pandemic is slowing down, we are seeing the revocation of these EUAs beginning to unfold. The companies listed in this NOA requested the revocation for their specific products. The FDA determined that it was appropriate to revoke the authorization to protect public health and safety.
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