Are data from foreign clinical studies accepted by FDA?
A study conducted under an investigational device exemption (IDE) outside the United States and submitted in support of a PMA must comply with the IDE regulation (21 CFR 812). A study conducted outside the U.S. which was not conducted under an IDE must comply with one of the following: • Research begun on or after effective date November 19, 1986: FDA will accept studies which have been conducted outside the U.S. and begun on or after November 19, 1986, if the data constitute valid scientific evidence (§860.7) 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 was conducted, whichever offers greater protection to the human subjects. If the standards of the country are used, the applicant must state in detail any differences between those standards and the Declaration of Helsinki and explain why the national standards offer greater protection to the human subjects. • Research b
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