Title 21
PART 809
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.
| 21:8.0.1.1.7.1 | SUBPART A | Subpart A - General Provisions | |
| 21:8.0.1.1.7.1.1.1 | SECTION 809.3 | 809.3 Definitions. | |
| 21:8.0.1.1.7.1.1.2 | SECTION 809.4 | 809.4 Confidentiality of submitted information. | |
| 21:8.0.1.1.7.2 | SUBPART B | Subpart B - Labeling | |
| 21:8.0.1.1.7.2.1.1 | SECTION 809.10 | 809.10 Labeling for in vitro diagnostic products. | |
| 21:8.0.1.1.7.2.1.2 | SECTION 809.11 | 809.11 Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile. | |
| 21:8.0.1.1.7.3 | SUBPART C | Subpart C - Requirements for Manufacturers and Producers | |
| 21:8.0.1.1.7.3.1.1 | SECTION 809.20 | 809.20 General requirements for manufacturers and producers of in vitro diagnostic products. | |
| 21:8.0.1.1.7.3.1.2 | SECTION 809.30 | 809.30 Restrictions on the sale, distribution and use of analyte specific reagents. | |
| 21:8.0.1.1.7.3.1.3 | SECTION 809.40 | 809.40 Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing. |