In Vitro Diagnostic Device Studies Exempt from Investigational Device Exemption Requirements
This guidance addresses the regulatory framework and requirements for In Vitro Diagnostic (IVD) device studies, particularly focusing on studies that are exempt from most IDE requirements. It aims to assist manufacturers, sponsors, applicants, investigators and the IVD industry in developing IVD studies and navigating the regulatory pathway from investigation to marketing.
Recommended Actions
- Determine if study qualifies for IDE exemption under 21 CFR 812.2(c)(3)
- If not exempt:
- Assess risk level (significant vs non-significant)
- Submit IDE application if significant risk
- Follow abbreviated requirements if non-significant risk
- Establish quality systems approach including:
- Device accountability and traceability
- Staff training documentation
- Data monitoring procedures
- Adverse event reporting system
- Develop comprehensive protocol including:
- Study objectives and design
- Statistical analysis plan
- Subject population definition
- Specimen handling procedures
- Implement human subject protection measures:
- IRB review and approval
- Informed consent process
- Privacy protections
- Subject safety monitoring
- Maintain detailed records of:
- All correspondence
- Device receipt and disposition
- Subject case histories
- Protocol deviations
- Adverse events
- Submit required reports:
- Progress reports (at least annually)
- Adverse event reports
- Final study report
- Any FDA-requested information
- Ensure proper labeling compliance throughout study
- Avoid any promotion or commercialization of investigational device
Key Considerations
Clinical testing
- Studies should be performed in a representative sample of the intended use population
- Multiple testing of same subject should be avoided as it may skew performance statistics
- Clinical investigators must use medically established means of diagnosis for all subjects in exempt studies
- For studies without medically established diagnostic confirmation, IDE approval may be required
Human Factors
- All IVD studies using human specimens involve human subjects and require human subject protection
- Informed consent requirements apply unless specific exemption criteria are met
- IRB review and approval required for studies supporting FDA applications
Labelling
- Must comply with 21 CFR 809.10(c) for investigational devices
- Must include “For Investigational Use Only” statement
- Must describe performance characteristics not yet established
Safety
- Risk determination based on potential harm from misdiagnosis
- False positive/negative results must be evaluated for safety impact
- Significant risk devices require full IDE approval
- Non-significant risk devices follow abbreviated IDE requirements
Other considerations
- Quality systems approach recommended for study conduct
- Detailed records must be maintained for all study aspects
- Electronic records should comply with 21 CFR Part 11
- Promotion and commercialization of investigational devices prohibited
- Foreign data may be accepted if applicable to US population
Relevant Guidances
- Electronic Records and Electronic Signatures - Scope and Application
- Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
- Continuing Review of Clinical Investigations by Institutional Review Boards (IRBs)
- Quality System Information Requirements for Premarket Submissions
Related references and norms
- 21 CFR Part 11: Electronic Records; Electronic Signatures
- 21 CFR Part 50: Protection of Human Subjects
- 21 CFR Part 56: Institutional Review Boards
- 21 CFR Part 809: In Vitro Diagnostic Products for Human Use
- 21 CFR Part 812: Investigational Device Exemptions
- 21 CFR Part 820: Quality System Regulation
Original guidance
- In Vitro Diagnostic Device Studies Exempt from Investigational Device Exemption Requirements
- HTML / PDF
- Issue date: 2010-06-25
- Last changed date: 2020-02-28
- Status: FINAL
- Official FDA topics: Medical Devices, Good Clinical Practice (GCP), Laboratory Tests, Premarket, IVDs (In Vitro Diagnostic Devices), Biologics
- ReguVirta summary file ID: fd88e55efa0376ec23880ef6744faa84
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