21 CFR Part 809 — In Vitro Diagnostic Products for Human Use
Subpart A — General Provisions
Subpart B — Labeling
Subpart C — Requirements for Manufacturers and Producers
- § 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.