FDA updates acceptance policy regarding international clinical data

The FDA has drafted an updated guideline policy regarding premarket submissions for devices using foreign clinical data to provide greater clarity on their stance regarding the matter.

“FDA acknowledges…that certain challenges exist in using data derived from foreign studies of devices to support an FDA marketing authorization. The challenges may be of such a degree that the study is not adequate by itself to demonstrate that the device, when used in the U.S. in the intended U.S. population, meets the applicable U.S. statutory premarketing review standard,” the authors wrote.

The guidance addresses what considerations sponsors should keep in mind when they are planning to rely on foreign data, including the difference in clinical conditions. The guidance states that countries outside the U.S. may have diverse standards of care, clinical facilities and clinical skill levels, all of which could affect the data in support of the device.

Differences in study populations and difference in regulatory requirements are also things sponsors should consider before submitting foreign data. The FDA noted that the prevalence of smoking, diabetes and obesity varies widely among countries, and that those factors, in addition to race, gender, age and demographics, should be well documented in submitted data. If a sponsor decides those factors are irrelevant to the data, they should clearly describe why they believe those difference would not impact the safety and effectiveness of the device.

The FDA has also proposed a rule, the Human Subject Protection: Acceptance of Data from Clinical Studies for Medical Devices, that when finalized, would require foreign clinical data to be gathered with good clinical practice (GCP). The FDA describes GCP as “a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials in a way that provides assurance that the data and reported results are credible and accurate and that the rights, safety and well-being of trial subjects are protected.” The proposed rule would require foreign clinical studies to be reviewed by an independent ethics committee and provide documentations of freely given, informed consent from study participants.

Those wishing to provide comments or feedback regarding the draft guidance have 90 days, and should submit their comments to http://www.regulations.gov.