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IRB Registration Requirements and Procedures

This guidance assists Institutional Review Boards (IRBs) in complying with FDA's requirement for IRB registration. It applies to all IRBs in the United States that review FDA-regulated studies and provides voluntary registration options for non-U.S. IRBs.

  1. Register IRB through the HHS electronic system if not already registered
  2. Ensure all required information is provided accurately
  3. Implement a process to track registration renewal every 3 years
  4. Establish procedures to update registration information within required timeframes:
    • 90 days for contact information changes
    • 30 days for changes in types of products reviewed
    • 30 days for IRB disbandment
  5. Maintain documentation of registration and updates
  6. Monitor compliance with registration requirements as part of quality system
  7. Train relevant personnel on registration requirements and procedures

Key Considerations

Other considerations

  • 21 CFR Part 56: Institutional Review Boards
  • 21 CFR Part 312: Investigational New Drug Application
  • 21 CFR Part 812: Investigational Device Exemptions

Original guidance

  • IRB Registration Requirements and Procedures
  • HTML / PDF
  • Issue date: 2009-07-09
  • Last changed date: 2021-07-21
  • Status: FINAL
  • Official FDA topics: Medical Devices, Drugs, Good Clinical Practice (GCP), Biologics
  • ReguVirta summary file ID: d267f5bc270d41551295530ea6ed4f1b
This post is licensed under CC BY 4.0 by the author.