Device Cos. Get FDA Guidance On Computer Simulation

Law360, New York (January 17, 2014, 4:35 PM EST) -- The U.S. Food and Drug Administration on Friday explained what sort of information is required of device makers when submitting data from computerized simulations as part of approval applications, a move aimed at eliminating confusion about agency expectations and harmonizing reviews.

Much of the draft guidance took a high-level approach to formatting of sections on so-called computational modeling and simulation, or CM&S, that are included in applications for product approval.

The FDA, for example, provided a template describing how various sections of submissions should be labeled...
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