The COVID Project
The record
- Jurisdiction
- United States
- Level
- Federal
- Authority
- FD&C Act § 564
- Issued
- 2020-03-24 Mar. 24, 2020
- Effective
- 2020-03-24
- End
- through the § 564 emergency (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 (ventilators, PPE, decontamination systems)
- Functions reached
- context for SC (ventilators, face shields, gowns, decontamination)
- Collection
- Federal health, safety and transport layer FED-A
Operative words
The Office of the Assistant Secretary for Preparedness and Response, HHS, requested that the FDA, HHS, issue an EUA for certain medical devices to allow the Department to take response measures based on information currently available about the virus that causes COVID-19. The determination of a public health emergency, and the declaration that circumstances exist justifying emergency use of certain medical devices by the Secretary of HHS, as described below, enable the FDA Commissioner to issue an EUA for these devices for emergency use under section 564 of the FD&C Act.
Enforcement
Notes
Retrieval notecontext; declaration date March 24, 2020 taken from the notice's Section III (confirm from exhibit).