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FDA to revise regulations for acceptance of data from medical device trials conducted outside of US April 28, 2013

Posted by Michael Hamrell in Regulatory Thoughts.
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In February 2013 the FDA proposed to amend the regulations in §814 regarding the acceptance of data from medical device trials. The current regulation in §814.15 states that FDA will accept the data if the data are valid and the investigator has conducted the studies in conformance with the Declaration of Helsinki or the laws and regulations of the country in which the research is conducted, whichever accords greater protection to the human subjects. In addition, the regulations regarding 510K submissions and investigational device exemptions (IDE) do not address the acceptance by FDA of data generated outside of the US.

FDA will accept information on clinical studies conducted outside the United States to support an IDE or a device marketing application (510K or PMA) or other submission if the data are valid and the information specified in other sections is submitted. The first item is a statement should be provided that all such studies have been conducted in accordance with good clinical practice (GCP). For the purposes of this section, GCP is defined 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 sponsor or applicant who submits data from a clinical study conducted outside the United States in support of an IDE or a device marketing application or submission, in addition to information required, shall provide a description of the actions the sponsor or applicant took to ensure that the research conformed to GCP.

When implemented, this regulation will be similar in language and scope to the updated language added to the IND/NDA regulations in 2008 in §312.120. It will thus provide greater consistency in expectations for the conduct of studies outside of the US for drugs, devices and biologics by defining a single standard of conduct as good clinical practice (GCP). As with the drug regulations, it will eliminate a direct reference to the Declaration of Helsinki (DoH) and a particular version of the declaration in the regulations. This is not to imply that the FDA and the US government do not support the Declaration of Helsinki. On the contrary, the DoH is still the foundation document for the ethical conduct of clinical trials. It is in fact referenced in the ICH GCP Guideline (E6), the ISO 141255 Guideline for Medical Device clinical trials, the Pan American Health Organization (PAHO), World Health Organization (WHO) and CIOMS Guidances on good clinical practice and ethical considerations in clinical trials as the ethical basis for these Guidelines. Collectively, these documents all define a standard of conduct known as GCP and documents that the FDA references as GCP.

No timetable is provided for the finalization and implementation of these proposed changes to the regulations.  It is still pending final approval and publication.