About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

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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