The COVID Project
The record
- Jurisdiction
- United States (federal); Food and Drug Administration
- Level
- Federal
- Authority
- Federal Food, Drug, and Cosmetic Act s. 564 (21 U.S.C. 360bbb-3); s. 701(h) guidance; 21 C.F.R. 10.115
- Issued
- 2020-02-29 Feb. 29, 2020
- Effective
- 2020-02-29 (immediately in effect; FR notice Mar. 6, 2020) (read as 2020-02-29)
- End
- Through the public health emergency (superseded by later versions of the COVID-19 test policy) (read as 2021-09-30)
- In force
- Feb. 29, 2020 to Sept. 30, 2021
- Quarters
- 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
- Limitation types
- Health care ordersOther
- Addressees
- clinical laboratories certified under CLIA to perform high-complexity testing
- Functions reached
- DX diagnostics and laboratory
- SC supply chain (test kits)
- Collection
- Other federal health agencies AGY-FED-HEALTH-OTHER
Operative words
On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV).... The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.
Enforcement
FDA premarket requirements under 21 U.S.C. 331, 351-352 relaxed for the described laboratories
Notes
The first FDA COVID-19 policy; predicate for hospital, academic and commercial laboratories' in-house tests.