Listed below are some of the regulations that implement the Act and that are relevant to IVDs covered by this guidance. This is not an all-inclusive list.:;
- Title 21, Code of Federal Regulations (21 CFR)
- Part 11, Electronic Records; Electronic Signatures
- Part 50, Protection of Human Subjects
- Part 54, Financial Disclosure by Clinical Investigators
- Part 56, Institutional Review Boards
- Part 801, Labeling
- Part 803, Medical Device Reporting
- Part 807, Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
- Part 809, In Vitro Diagnostic Products for Human Use
- Part 810, Medical Device Recall Authority
- Part 812, Investigational Device Exemptions
- Part 814, Premarket Approval of Medical Devices
- Part 820, Quality System Regulation
- Part 860, Medical Device Classification Procedures
- Part 862, Clinical Chemistry and Clinical Toxicology Devices
- Part 864, Hematology and Pathology Devices
- Part 866, Immunology and Microbiology Devices
In addition, certain sections of Part 610 apply to devices that employ human blood components. For example: 610.40, Test Requirements (Testing Requirements for Communicable Disease Agents) 610.42, Restrictions on Use for Further Manufacture of Medical Devices
