The COVID Project
The record
- Jurisdiction
- United States (federal); Food and Drug Administration
- Level
- Federal
- Authority
- FD&C Act s. 564(h)(1) (publication of EUAs)
- Issued
- 2020-06-05 June 5, 2020
- Effective
- Authorizations effective on their dates of issuance (Mar. 2-Apr. 2020) (read as 2020-06-05)
- End
- Various (decontamination EUAs revoked June 30, 2021; imported FFR EUAs revoked July 6, 2021) (read as 2021-06-30)
- In force
- June 5, 2020 to June 30, 2021
- Quarters
- 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
- Limitation types
- Health care ordersSupply chain
- Addressees
- device manufacturers, importers, distributors, health care personnel
- Functions reached
- SC supply chain
- PF production floor
- IC infection control (PPE)
- Collection
- Other federal health agencies AGY-FED-HEALTH-OTHER
Operative words
Section 564 of the FD&C Act permits FDA to authorize the introduction into interstate commerce of a drug, device, or biological product intended for use when the Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use.... Certain ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators... issued March 24, 2020
Enforcement
Authorization of otherwise-prohibited interstate commerce in unapproved devices under 21 U.S.C. 331
Notes
Reprints the ventilator, respirator, imported-respirator, Battelle, STERIS and face-shield EUAs of March-April 2020.