New acceptance guidelines proposed by the FDA regarding clinical data on medical devices gathered overseas have created a stir in the industry. The FDA noted that “increasing globalization of clinical trials presents challenges to both U.S. and foreign regulators,” and among those challenges are resource constraints posed by the increase in the number of applications for approval and clearance of medical devices based on clinical trials conducted in foreign countries.
According to the FDA’s Safety and Innovation Act of 2012, the regulatory agency is required to accept data collected in foreign countries as long as the trials were conducted under reputable clinical practice. However, the new FDA guidance stipulates that overseas trials have to be conducted in conformance with either the local country’s laws or an international law known as the Declaration of Helsinki—whichever are more stringent. Accepting trials completed overseas, however, does not automatically guarantee FDA approval, as certain factors such as study populations and regulatory requirements “could impact the data’s usefulness in supporting the safety and/or effectiveness of the device.”
In the early stages of drafting this new guidance, the FDA is working towards confirming a more all-encompassing rule to reinforce requirements of the FDA Safety and Innovation Act, aimed at protecting patients from experiencing potentially life-threatening complications associated with medical devices not tested in good faith.