The COVID Project
The record
- Jurisdiction
- United States
- Level
- Federal
- Authority
- Federal Food, Drug, and Cosmetic Act § 564 (21 U.S.C. § 360bbb-3)
- Issued
- 2020-02-04 Feb. 4, 2020
- Effective
- 2020-02-04 ('The determination and declaration took effect February 4, 2020') (read as 2020-02-04)
- End
- through the § 564 emergency (terminated 2024-2025; not verified) (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 declarationHealth care orders
- Addressees
- FDA; manufacturers and laboratories of COVID-19 diagnostics
- Functions reached
- context: the earliest federal emergency determination (Feb. 4, 2020); the legal basis of every COVID-19 test EUA
- Collection
- Federal health, safety and transport layer FED-A
Operative words
On February 4, 2020, the Secretary determined pursuant to his authority under section 564 of the FD&C Act 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 a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). On the basis of this determination, he also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of this novel coronavirus (2019-nCoV) pursuant to section 564 of the FD&C Act
Enforcement
Framework for FDA emergency use authorizations
Notes
CONTEXT ONLY. The four § 564 declarations (FED-181 to FED-184) are the framework under which the tests, respirators, ventilators, drugs and vaccines that every State and federal order presupposed were lawfully marketed.