FDA Urgent Notification --- 3 New Requirements for EUA Approval of COVID-19 Tests

Original from: FDA

On September 23,  FDA sent a letter to all manufacturers that received EUA authorization for COVID-19 tests, urgently notifies all these manufacturers of three new requirements for their EUA-authorized tests.

The content: 

On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of HHS then declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 subject to the terms of any authorization issued under Section 564(a) of the Act.1 FDA subsequently authorized the emergency use of numerous in vitro diagnostics (IVDs) for detection and/or diagnosis SARS-CoV-2, the virus that causes COVID-19. 

Pursuant to Section 564 of the Act, and in response to the continued emergence of new genetic viral variants of SARS-CoV-2,3 FDA is issuing this letter to establish additional Conditions of Authorization on EUAs that are within the Scope of this Revision (Section I). 

For more information, please download the file: EUA Letter of Condition - Viral Mutation Revision