FDA Eyes New Rule For Foreign Clinical Data On Devices

Law360, New York (February 25, 2013, 7:39 PM EST) -- The U.S. Food and Drug Administration issued a proposed rule Monday that would change the requirements for when and how medical device sponsors can use clinical trial data from other countries, and expand the requirements to 510(k) and investigational device exemption applications.

The regulation concerning foreign clinical trial for medical devices was last visited in 1986, and since then standards for good clinical practices, which seek to protect human subjects as well as the integrity of the data, have “evolved considerably,” the FDA said.

Also, the...
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