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.
|21:188.8.131.52.184.108.40.206||SECTION 809.20||809.20 General requirements for manufacturers and producers of in vitro diagnostic products.|
|21:220.127.116.11.18.104.22.168||SECTION 809.30||809.30 Restrictions on the sale, distribution and use of analyte specific reagents.|
|21:22.214.171.124.126.96.36.199||SECTION 809.40||809.40 Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.|