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Use of Leftover Human Specimens in IVD Device Studies: Requirements for IDE Exemption and Privacy Protection

This guidance applies to IVD device investigations regulated by FDA that are exempt from most IDE requirements and use leftover specimens that are not individually identifiable. This includes remnants of human specimens collected for routine clinical care, specimens from repositories, and specimens previously collected for unrelated research, where the subject's identity is not known or readily ascertainable.

  1. Verify that the study meets IDE exemption criteria
  2. Establish procedures to ensure specimens are not individually identifiable
  3. Document policies and procedures for protecting subject privacy
  4. Implement separation between clinical care team and research team
  5. Obtain IRB review and approval
  6. Maintain documentation of compliance with guidance requirements
  7. Assess whether the study design will generate sufficient data for intended regulatory submission
  8. Establish procedures to handle any critical findings that require clinical reporting
  9. Review specimen collection procedures to ensure only true “leftover” specimens are used
  10. Implement proper coding procedures if specimens are coded

Key Considerations

Safety

  • No new medical risks should be posed to subjects
  • Test results should not be used for clinical management of the subject
  • Results should not be reported to the subject’s healthcare provider (with exceptions for critical findings)

Other considerations

  • 21 CFR 812: Investigational Device Exemptions
  • 21 CFR 50: Protection of Human Subjects
  • 21 CFR 56: Institutional Review Boards

Original guidance

  • Use of Leftover Human Specimens in IVD Device Studies: Requirements for IDE Exemption and Privacy Protection
  • HTML / PDF
  • Issue date: 2006-04-25
  • Last changed date: 2024-03-22
  • Status: FINAL
  • Official FDA topics: Radiation-Emitting Products, Medical Devices, Good Clinical Practice (GCP), Premarket, Biologics
  • ReguVirta summary file ID: bb51f60c79f232b3e4ef2d3ee5b32086
This post is licensed under CC BY 4.0 by the author.