Last month, FDA released a draft guidance document detailing the ways in which data from clinical studies outside the United States can be used in support of medical device premarket submissions. The draft guidance reiterates that medical device applications must be supported by valid scientific evidence, regardless of source, and advises clinical sponsors to consider differences in clinical settings, study populations, and regulatory requirements when developing investigations. FDA has long accepted foreign data for certain medical devices, and its regulations specifically address the use of such data in premarket approval ("PMA") applications.
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