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