Post

Certifying Compliance with Clinical Trial Registration Requirements on Form FDA 3674

This guidance clarifies FDA's requirements regarding Form FDA 3674 certifications that must accompany certain drug, biological product, and device applications/submissions. The certification confirms compliance with clinical trial registration and results reporting requirements under Title VIII of FDAAA.

  1. Implement process to submit Form FDA 3674 with:
    • INDs and new clinical protocols
    • NDAs and efficacy supplements
    • BLAs and efficacy supplements
    • ANDAs
    • PMAs and panel track supplements
    • HDEs
    • 510(k)s referencing clinical trials
  2. Ensure Form FDA 3674 includes:
    • Appropriate NCT numbers when available
    • Accurate certification of compliance
  3. Establish tracking system for:
    • Clinical trial registration status
    • Results reporting compliance
    • NCT number documentation
  4. Train regulatory staff on:
    • When certification is required
    • How to complete Form FDA 3674
    • Enforcement discretion categories
  5. Implement quality check to verify certification requirements before submission

Key Considerations

Clinical testing

  • Certification required for applications/submissions containing clinical trial information
  • Applicable to clinical trials that must be registered on ClinicalTrials.gov
  • New clinical protocols submitted to an IND require certification

Other considerations

  • 21 CFR 50.25(c): Requirements for informed consent documents
  • 42 CFR part 11: Clinical trials registration and results information submission
  • 21 CFR 312.3: IND definitions
  • 21 CFR 312.30(a): Protocol amendments

Original guidance

  • Certifying Compliance with Clinical Trial Registration Requirements on Form FDA 3674
  • HTML / PDF
  • Issue date: 2017-06-07
  • Last changed date: 2020-01-21
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Drugs, Biologics
  • ReguVirta summary file ID: 91019d8b0d87b7a374f3b9219948ef44
This post is licensed under CC BY 4.0 by the author.