Frequently Asked Questions

Which regulations contain provisions relevant to in vitro diagnostic (IVD) devices?

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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
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