Determination of Public Health Emergency and Declaration that circumstances exist justifying emergency use of in vitro diagnostics, 85 Fed. Reg. 7316 (Feb. 7, 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)

Issued

2020-02-04 Feb. 4, 2020

Effective

2020-02-04

End

In force throughout 2020-2021 (read as 2021-09-30)

In force

Feb. 4, 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; test developers and laboratories

Functions reached

• DX diagnostics
• SC supply chain

Collection

Other federal health agencies AGY-FED-HEALTH-OTHER

Operative words

I declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV) pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.... DATES: The determination and declaration took effect February 4, 2020.

Enforcement

Notes