Title 21

PART 809 SUBPART C

Subpart C - Requirements for Manufacturers and Producers

• 21 U.S.C. 331, 351, 352, 355, 360b, 360c, 360d, 360h, 360i, 360j, 371, 372, 374, 381.

21:8.0.1.1.7.3.1.1	SECTION 809.20	809.20 General requirements for manufacturers and producers of in vitro diagnostic products.
21:8.0.1.1.7.3.1.2	SECTION 809.30	809.30 Restrictions on the sale, distribution and use of analyte specific reagents.
21:8.0.1.1.7.3.1.3	SECTION 809.40	809.40 Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.

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