21 CFR 801.119
§ 801.119 In vitro diagnostic products.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 801.119, § 801.119 In vitro diagnostic products, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88678
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Full text
A product intended for use in the diagnosis of disease and which is an in vitro diagnostic product as defined in § 809.3(a) of this chapter shall be deemed to be in compliance with the requirements of this part and section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act if it meets the requirements of subpart B of this part and the requirements of § 809.10 of this chapter.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.