Code of Federal Regulations (Last Updated: October 10, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 862 - Clinical Chemistry and Clinical Toxicology Devices |
Subpart A - General Provisions |
§ 862.1 - Scope. |
§ 862.2 - Regulation of calibrators. |
§ 862.3 - Effective dates of requirement for premarket approval. |
§ 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |