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Regulations last checked for updates: Aug 02, 2025
Title 21 - Food and Drugs last revised: Jul 28, 2025
All Titles
Title 21
Chapter I
Part 809 - PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
Subpart A [§ 809.3 - § 809.4] -
Subpart B [§ 809.10 - § 809.11] - Subpart B—Labeling
Subpart C [§ 809.20 - § 809.40] - Subpart C—Requirements for Manufacturers and Producers
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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