FDA 21 CFR Part 809 In Vitro Diagnostic Products For Human Use:
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Table of contents
Subpart A - General Provisions
809.4 Confidentiality of submitted information.
809.10 Labeling for in vitro diagnostic products.
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.
FDA 21 CFR Part 809 In Vitro Diagnostic Products For Human Use:
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