In a resounding manner, members of the medical device industry recently filed comments reacting to the Food and Drug Administration’s proposed rule to strengthen its oversight of overseas clinical studies of medical devices. The proposed rule would replace the current practice, which does not require review by an independent ethics committee. Currently, FDA accepts data from clinical trials conducted outside the U.S. if the data are valid and the studies are conducted in conformance with the 1983 Declaration of Helsinki or the laws and regulations of the country in which the research is conducted, whichever accords greater protection to human subjects.
The proposed rule, however, would impose new reporting requirements when data from clinical studies for medical devices conducted outside the U.S.are submitted as support for an device exception, a 510(k) premarket notification submission, a premarket approval application, a product development protocol application, or a humanitarian device exemption application. In such cases, applicants would have to demonstrate to FDA that the study was conducted in accordance with “good clinical practice.” Under the proposed rule, proof of good clinical practice includes obtaining “the review and approval of the study by an independent ethics committee,” as well as a record of the informed consent of study participants. FDA would further require applicants to provide records detailing the qualifications of ethics committee members, their approval process, information about the research facility, and descriptions of how researchers obtained informed consent and monitored their subjects.
Comments submitted to FDA by the medical device industry have resoundingly critiqued the new rule as imposing stricter regulations than those required for domestic clinical trials, while ignoring barriers presented by other countries’ laws. Some propose that before implementing the proposed rule, FDA should first create consistency between international and U.S.definitions and guidelines, as currently not all foreign countries permit disclosure of the information required for compliance with the proposed rule. Others point out that studies are oftentimes conducted overseas without plans to apply for approval from the U.S., and the data from such studies should not be summarily excluded. As to potential alternative solutions, it was proposed by at least one commenter that the FDA should instead adopt the standard ISO-14155:2011, which is already recognized by all members of the International Medical Device Regulators Forum. After the overwhelming response by industry, many are anticipating that FDA may initiate additional changes to the regulations before a final rule is implemented.
Stay tuned as we continue to follow this important legal and regulatory issue.
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