FDA 21 CFR Part 809 In Vitro Diagnostic Products For Human Use

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Table of contents 

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.

FDA 21 CFR Part 809 In Vitro Diagnostic Products For Human Use: