FDA Aims To Boost Device Makers' Faith In Early Meetings

Law360, New York (July 12, 2012, 8:49 PM EDT) -- The U.S. Food and Drug Administration on Thursday released guidelines aimed at giving medical device makers more confidence in the all-important feedback they get from the FDA before the review process begins, feedback industry experts say has been frustratingly inconsistent.

The draft guidance, which the FDA committed to release in this year's renewed medical device user fee agreement, outlines the process for the presubmission meetings between device sponsors and agency reviewers that take place before the sponsor officially submits its application.

Device makers rely on the...
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