Emergency Use Authorization Declaration (medical devices, including alternative products used as medical devices), 85 Fed. Reg. 17335 (Mar. 27, 2020)

The record

Jurisdiction

United States (federal); Department of Health and Human Services, Office of the Secretary

Level

Federal

Authority

FD&C Act s. 564(b)(1)(C) (21 U.S.C. 360bbb-3(b)(1)(C))

Issued

2020-03-24 Mar. 24, 2020

Effective

2020-03-24 (determination effective Feb. 4, 2020) (read as 2020-03-24)

End

Terminated by HHS notice effective in 2026 (post-period); in force throughout 2020-2021 (read as 2021-09-30)

In force

Mar. 24, 2020 to Sept. 30, 2021

Quarters

2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3

2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3

Limitation types

Emergency declarationSupply chain

Addressees

• FDA; device manufacturers and users

Functions reached

• SC supply chain
• PF production floor (converted manufacturing)

Collection

Other federal health agencies AGY-FED-HEALTH-OTHER

Operative words

I declared that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.

Enforcement

Notes