Several sections of Title 21 in the Code of Federal Regulations (CFR) contain clauses that pertain to IVDs. These are listed in the table below:
- 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 Regulations
- 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
