21 CFR 809.20

§ 809.20 General requirements for manufacturers and producers of in vitro diagnostic products.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 809.20, § 809.20 General requirements for manufacturers and producers of in vitro diagnostic products, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88788
Permanent ID: ys:prov:88788@1
SHA-256: 4734a6962ba0c186ff3f083ec8764a3b4e81bb1722f21fea13337f2a5590d175

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Full text

(a) [Reserved] (b) Compliance with good manufacturing practices. In vitro diagnostic products shall be manufactured in accordance with the good manufacturing practices requirements found in part 820 of this chapter and, if applicable, with § 610.44 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.