Acceptance of Clinical Data to Support Medical Device Applications and Submissions
This guidance clarifies FDA's requirements for accepting clinical data from investigations conducted both within and outside the United States (OUS) to support medical device applications and submissions. It focuses on ensuring data quality, integrity, and human subject protection through Good Clinical Practice (GCP) compliance.
Recommended Actions
- Assess if clinical investigations comply with GCP requirements
- Document IEC review and approval process
- Maintain records of informed consent procedures
- Prepare detailed descriptions of research facilities and investigator qualifications
- Implement monitoring procedures to ensure protocol compliance
- Consider waiver requests if unable to meet specific requirements
- Ensure proper documentation retention for at least 2 years
- Review implementation timeline and plan accordingly for new studies
- Evaluate multi-center studies for compliance with local requirements
- Prepare statements regarding GCP compliance for submissions
Key Considerations
Clinical testing
- Clinical investigations must be conducted in accordance with GCP
- For OUS studies, sponsors must demonstrate data adequacy under FDA standards
- Multi-center studies must comply with local requirements for each site
Safety
- Protection of human subjects’ rights, safety and well-being must be ensured
- Independent Ethics Committee (IEC) review and approval required
- Informed consent must be obtained from subjects
- Continuing review by IEC required during the study
Other considerations
- Documentation of investigator qualifications required
- Description of research facilities needed
- Monitoring procedures must be described
- Records must be maintained for at least 2 years after FDA decision
- Waiver requests possible for specific requirements if justified
- Implementation effective one year after publication
Relevant Guidances
- Format for Clinical Data Presentations in Orthopedic Implant Device Submissions
- Design Considerations for Medical Device Pivotal Clinical Studies
- Sex-Specific Considerations in Medical Device Clinical Studies: Patient Enrollment, Data Analysis and Reporting
- CLIA Waiver Applications for In Vitro Diagnostic Devices - Demonstrating Simplicity and Insignificant Risk of Erroneous Results
Related references and norms
- ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects - Good Clinical Practice
- ICH E6: Good Clinical Practice: Consolidated Guideline
Original guidance
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions
- HTML / PDF
- Issue date: 2018-02-21
- Last changed date: 2023-08-10
- Status: FINAL
- Official FDA topics: Medical Devices, Good Clinical Practice (GCP), Premarket, Biologics, Investigational Device Exemption (IDE)
- ReguVirta summary file ID: 026a8cd78d5e0418eb327cf80d8db7e7
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