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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 809 - In Vitro Diagnostic Products for Human Use |
| Subpart A - General Provisions |
| § 809.3 - Definitions. |
| § 809.4 - Confidentiality of submitted information. |
| § 809.5 - Exemption from batch certification requirements for in vitro antibiotic susceptibility devices subject to section 507 of the act. |
| § 809.6 - Conditions on the effectiveness of exemptions of antibiotic susceptibility devices from batch certification requirements. |
| 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. |