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Regulations last checked for updates: May 14, 2025
Title 21 - Food and Drugs last revised: May 12, 2025
All Titles
Title 21
Chapter I
Part 809
Subpart C - Subpart C—Requirements for Manufacturers and Producers
§ 809.20 - General requirements for manufacturers and producers of in vitro diagnostic products.
§ 809.30 - Restrictions on the sale, distribution and use of analyte specific reagents.
§ 809.40 - Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.
authority:
21 U.S.C. 321
(h)(1), 331, 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 371, 372, 374, 381, and
42 U.S.C. 262.
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