Federal (United States) · Regulations
Subpart C — Requirements for Manufacturers and Producers
3 sections
3 sections
- 21 C.F.R. § 809.20General requirements for manufacturers and producers of in vitro diagnostic products.
- 21 C.F.R. § 809.30Restrictions on the sale, distribution and use of analyte specific reagents.
- 21 C.F.R. § 809.40Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.