FDA releases guidance on clinical trials backing PMA applications

08/17/2011 | MassDevice.com (Boston)

The FDA has issued another guidance outlining the basic features of clinical trials designed to support medical devices seeking premarket approval, which will be up for comment over the next three months. The guidance, which may also be applicable to 510(k) submissions, "will help manufacturers and researchers better understand the FDA's basic expectations for clinical trials," said Dr. Jeffrey Shuren, director of the FDA's device center.

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MassDevice.com (Boston)

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