New FDA guidance on considerations used in device approval, de novo decisions

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: New FDA guidance on considerations used in device approval, de novo decisions

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New FDA guidance on considerations used in device approval, de novo decisions

03/27/2012 10:06 AM EDT

The U.S. Food and Drug Administration today published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of certain medical devices are considered during pre-market review.

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