By Stewart Eisenhart, Emergo Group
New draft guidance from the US Food and Drug Administration proposes Good Clinical Practice (GCP) compliance for accepting medical device clinical data from studies conducted in foreign countries, and also outlines criteria the agency uses for accepting such data as part of medical device premarket registration submissions.
As detailed in the guidance, US regulators may currently accept clinical data obtained outside the US needed to support premarket submissions including 510(k) premarket notifications, Premarket Approvals (PMA), Investigational Device Exemptions (IDE) and De Novo Petitions. Furthermore, the Food and Drug Administration Safety and Innovation Act of 2012 requires the agency to accept foreign clinical data under some conditions. However, foreign clinical data can be accepted for US device registrations only if certain standards and requirements are met.
Validity
Whether obtained in the US or through foreign studies, clinical data must first be scientifically valid in order to support an FDA premarket clearance or approval application. Applicants can and should request Pre-submission consultation with appropriate FDA review units to determine whether their existing clinical data can adequately support their US registration submissions, or if those firms will have to conduct studies in the US.
Clinical study conditions
Are there differences in clinical conditions in the country where an applicant’s study was conducted and conditions in the US? Conditions such as standards of care, clinical facilities and skill can all impact the relevance of an applicant’s foreign clinical data to the firm’s US market authorization effort. If an applicant’s foreign clinical data cannot be generalized to US clinical practice and requirements, additional US studies may be required.
Clinical study populations
Any disparities in a device’s safety or effectiveness between different demographic groups in the foreign population where an applicant’s clinical study was conducted have the potential to limit the usefulness of that study’s results for US premarket applications. Registrants should take care to report representations of their clinical populations—race, gender, ethnicity, age, etc.—thoroughly in their US application materials.
Applicants should also be aware of and report any major cultural, educational and language differences that could affect how their foreign clinical data may be interpreted and applied.
Regulatory requirements
Clinical studies designed and carried out according to the specifications and requirements of foreign regulators may not fully meet US FDA clinical study requirements. Studies designed to demonstrate device safety and performance, for example, do not fully address FDA requirements for safety and effectiveness.
Good Clinical Practice
In addition to data validity requirements, the FDA guidance proposes Good Clinical Practice (GCP) compliance requirements for clinical data obtained from foreign studies. The guidance notes that the agency already requires GCP compliance for IDE clinical studies; those same requirements for “design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials” that ensures both accuracy of clinical data and safety of trial subjects.
Interested parties have until July 20, 2015 to submit comments to the FDA regarding the new guidance.
