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.
Recommended Actions
- Verify that the study meets IDE exemption criteria
- Establish procedures to ensure specimens are not individually identifiable
- Document policies and procedures for protecting subject privacy
- Implement separation between clinical care team and research team
- Obtain IRB review and approval
- Maintain documentation of compliance with guidance requirements
- Assess whether the study design will generate sufficient data for intended regulatory submission
- Establish procedures to handle any critical findings that require clinical reporting
- Review specimen collection procedures to ensure only true “leftover” specimens are used
- 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
- IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
- Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
- Continuing Review of Clinical Investigations by Institutional Review Boards (IRBs)
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 summary file ID: bb51f60c79f232b3e4ef2d3ee5b32086
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