21 CFR Part 809
PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
- PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter H—Medical Devices
- Subpart A—General Provisions
- § 809.3 Definitions.
- § 809.4 Confidentiality of submitted information.
- Subpart B—Labeling
- § 809.10 Labeling for in vitro diagnostic products.
- § 809.11 Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile.
- 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.
Feedback