The COVID Project
Context, not an orderThis record is guidance or an announcement kept for context. It is not counted among the orders in force.
The record
- Jurisdiction
- United States (federal); Food and Drug Administration, Center for Devices and Radiological Health
- Level
- Federal
- Authority
- FD&C Act ss. 510(k), 519, 520(f), 564; 21 C.F.R. 878.4040; enforcement discretion
- Issued
- 2020-03-25 Mar. 25, 2020
- Effective
- 2020-03-25 (immediately in effect) (read as 2020-03-25)
- End
- Superseded by the Sept. 5, 2023 policy; in force throughout 2020-2021 (read as 2023-09-05)
- In force
- Mar. 25, 2020 to Sept. 5, 2023
- Quarters
- 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
- Limitation types
- Face-covering requirementSupply chainOther
- Addressees
- manufacturers, importers and distributors of face masks, face shields and respirators
- Functions reached
- SC supply chain (masks)
- PF production floor (converted apparel and textile lines)
- IC infection control
- Character
- context
- Collection
- Other federal health agencies AGY-FED-HEALTH-OTHER
Operative words
This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19... FDA does not intend to object to the distribution and use of face masks, with or without a face shield... that are intended for a medical purpose... without compliance with... premarket notification requirements... where the face mask does not create an undue risk
Enforcement
Enforcement discretion under 21 U.S.C. 331 for the listed premarket, registration and labeling requirements
Notes
The saved file is FDA's Sept. 5, 2023 superseding version, which recites the March 2020 policy's history;
Retrieval noteOperative clause quoted from the 2020 policy as reproduced in the successor document's recitals and the May 12, 2020 FR notice (Ex. 033); downgraded to verified_secondary because the March 2020 text itself was not read. Cite it as context and cite the underlying order, statute or emergency rule it describes as the instrument. (Bulletins whose operative text imposes a mandatory duty on licensees under the regulator's own authority are excluded from this downgrade and listed separately for review.)).