Title 21, Part 809 — In Vitro Diagnostic Products for Human Use
7 sections
Section 809.3
Definitions.
Section 809.4
Confidentiality of submitted information.
Section 809.10
Labeling for in vitro diagnostic products.
Section 809.11
Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile.
Section 809.20
General requirements for manufacturers and producers of in vitro diagnostic products.
Section 809.30
Restrictions on the sale, distribution and use of analyte specific reagents.
Section 809.40
Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.