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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.

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By ReguVirta
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What You Need to Know? 👇

What is FDA’s enforcement discretion for IVD studies using leftover specimens?

FDA will not enforce informed consent requirements for IVD studies using leftover, non-identifiable specimens that meet IDE exemption criteria under 21 CFR 812.2(c)(3), provided specific privacy protections are maintained and IRB review occurs.

When are specimens considered “not individually identifiable” for IVD research purposes?

Specimens are not individually identifiable when investigators, sponsors, or study personnel cannot determine the subject’s identity directly or through coding systems. Clinical information may accompany specimens if it doesn’t reveal patient identity.

What documentation should sponsors maintain for studies under this enforcement discretion?

Sponsors should maintain written documentation covering all factors in section 4(a)-(g), including specimen provider policies ensuring subject anonymity. FDA may inspect this documentation, and IRBs should review it before study approval.

Can leftover specimens from previous research be used under this guidance?

Yes, leftover specimens from previous unrelated research can be used under this enforcement discretion, provided they are not individually identifiable and meet all other criteria outlined in the guidance.

What types of IVD studies are excluded from this enforcement discretion?

Studies excluded include those not meeting IDE exemption criteria, using identifiable specimens, collecting specimens specifically for the investigation, requiring more specimen than typically leftover, or reporting results to healthcare providers.

How does this guidance affect IRB responsibilities for IVD studies?

IRBs should review sponsor documentation regarding anonymity factors and apply enforcement discretion only to informed consent requirements. All other 21 CFR part 56 requirements remain fully applicable to these studies.

What You Need to Do 👇

  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

  • Study must meet IDE exemption criteria at 21 CFR 812.2(c)(3)
  • Specimens must be not individually identifiable
  • Clinical information can accompany specimens if it doesn’t make the source identifiable
  • Individuals caring for patients must be separate from those conducting the investigation
  • Specimens must be provided without identifiers
  • Supplier must have policies to prevent release of personal information
  • IRB review is required
  • Written documentation of compliance must be maintained
  • Privacy and confidentiality protections must be in place

Relevant Guidances 🔗

Related references and norms 📂

  • 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 ID: bb51f60c79f232b3e4ef2d3ee5b32086
FDA guidance, Final
Radiation-Emitting Products Medical Devices Good Clinical Practice (GCP) Premarket Biologics
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