The COVID Project
The record
- Jurisdiction
- United States (federal); Food and Drug Administration
- Level
- Federal
- Authority
- FD&C Act s. 564(c), (d)
- Issued
- 2021-03-24 Mar. 24, 2021
- Effective
- Original authorization Mar. 24, 2020 (read as 2020-03-24)
- End
- 2021-07-06 (revocation noticed at 86 Fed. Reg. 48712 (Aug. 31, 2021)) (read as 2021-07-06)
- In force
- Mar. 24, 2020 to July 6, 2021
- Quarters
- 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
- Limitation types
- Health care ordersSupply chain
- Addressees
- manufacturers, importers, distributors, health care personnel
- Functions reached
- SC supply chain (imports)
- IC infection control
- PT ports and customs (FDA import review)
- Collection
- Other federal health agencies AGY-FED-HEALTH-OTHER
Operative words
On March 24, 2020, in response to this public health emergency and concerns about filtering facepiece respirator (FFR or respirator) availability, FDA authorized the emergency use of certain imported disposable FFRs that are not approved by NIOSH... for use in healthcare settings by HCP to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages
Enforcement
Conditions of authorization; interstate commerce otherwise barred by 21 U.S.C. 331
Notes
Reached importers, freight forwarders, distributors and every health-care buyer; its revocation on July 6, 2021 is a Q3 2021 supply-chain change.
Retrieval noteThe saved letter is the Mar. 24, 2021 reissuance, which recites the Mar. 24, 2020 original.