CFR›Title 21›Chapter I›Part 809 ContainsSubparts A–CCorpusDaily eCFRDisplayed edition2026-04-24Last updated2026-04-24 PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE Subparts A Subpart A—General Provisions Sections 809.3–809.4 B Subpart B—Labeling Sections 809.10–809.11 C Subpart C—Requirements for Manufacturers and Producers Sections 809.20–809.40 Authority21 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. Previous 808 Part 808—Exemptions from Federal Preemption of State and Local Medical Device Requirements Next 810 Part 810—Medical Device Recall Authority