FDA Outlines Feedback Process For Medical Device Approvals

Law360, New York (February 14, 2014, 5:35 PM EST) -- The U.S. Food and Drug Administration on Friday finalized highly detailed guidance on how medical device manufacturers can seek agency feedback before seeking to test or sell a new product, delivering on a promise made as part of the 2012 user fee law.

The 57-page guidance covers a wide range of applications, including those requesting a so-called investigational device exemption, which allows a manufacturer to conduct clinical trials, and those requesting actual marketing approval.

Previously known as Pre-IDE, the program will now be referred to as...
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