FDA Unveils New Standards For Premarket Device Studies

Law360, New York (August 15, 2011, 3:41 PM EDT) -- The U.S. Food and Drug Administration issued a draft guidance Monday specifying how medical device makers should design clinical studies in order to help secure the agency's approval of a high-risk device, part of its yearlong effort to improve the device review process.

The guidance centers on studies that medical device companies conduct in their search for premarket approval of Class III medical devices. The agency also issued a draft guidance Monday regarding how it weighs benefits against risks when evaluating premarket, high-risk medical devices, the...
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