Findings
FDA requires OUS clinical investigations to comply with GCP, ensuring the credibility and accuracy of data and protecting human subjects.
Statements on GCP compliance and supporting information are mandatory for OUS data submissions.
Waivers are permitted in circumstances where GCP compliance is unattainable or where local regulations differ significantly from FDA requirements.
Investigations must demonstrate that OUS data are applicable to U.S. populations and medical practices.
Sponsors must provide robust documentation, including investigator qualifications, site descriptions, IEC reviews, and informed consent processes.

Recommendations
Ensure clinical investigations adhere to GCP standards, including IEC review and informed consent, for all OUS clinical data submitted to FDA.
Include detailed supporting information in submissions, such as investigator qualifications, facility descriptions, protocols, and data summaries.
Clearly identify any deviations from GCP and justify how data integrity and subject protection were maintained.
Use FDA’s Pre-Submission Program to discuss potential challenges with GCP compliance or data validation before submission.
Retain all required records for at least two years after FDA’s decision on the application or submission.

Regulatory Considerations
FDA evaluates OUS clinical data on a case-by-case basis, considering the adequacy of GCP compliance and supporting documentation.
For significant risk device investigations, sponsors must provide the most comprehensive documentation, while non-significant risk and exempt devices require less detailed information.
Waivers may be granted when justified by public health considerations or when local laws prohibit compliance with specific FDA requirements.
FDA retains the right to inspect clinical sites or review source documents to validate data integrity and compliance with GCP.
Sponsors must ensure that OUS data are valid and relevant to the U.S. population and medical practice.