Title 21

PART 809

Part 809 - In Vitro Diagnostic Products For Human Use

PART 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE Authority:21 U.S.C. 331, 351, 352, 355, 360b, 360c, 360d, 360h, 360i, 360j, 371, 372, 374, 381.

21:8.0.1.1.7.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.7.1.1.1SECTION 809.3
   809.3 Definitions.
21:8.0.1.1.7.1.1.2SECTION 809.4
   809.4 Confidentiality of submitted information.
21:8.0.1.1.7.2SUBPART B
Subpart B - Labeling
21:8.0.1.1.7.2.1.1SECTION 809.10
   809.10 Labeling for in vitro diagnostic products.
21:8.0.1.1.7.2.1.2SECTION 809.11
   809.11 Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile.
21:8.0.1.1.7.3SUBPART C
Subpart C - Requirements for Manufacturers and Producers
21:8.0.1.1.7.3.1.1SECTION 809.20
   809.20 General requirements for manufacturers and producers of in vitro diagnostic products.
21:8.0.1.1.7.3.1.2SECTION 809.30
   809.30 Restrictions on the sale, distribution and use of analyte specific reagents.
21:8.0.1.1.7.3.1.3SECTION 809.40
   809.40 Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.