Part 809 — In Vitro Diagnostic Products for Human Use
Current through Sep 8, 2026
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.
Sections
- § 809.3 Definitions.
- § 809.4 Confidentiality of submitted information.
- § 809.10 Labeling for in vitro diagnostic products.
- § 809.11 Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile.
- § 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.