FDA Draft Guidances Drag Out

Posted in Regulatory and Compliance by Jamie Hartford on March 28, 2014

Analysis by the law firm Epstein Becker & Green found that more than 90 draft guidances dating back as far as 1991 have yet to be finalized. 

At the end of the 2013 fiscal year last September, the law firm Epstein Becker & Green conducted a study of the outstanding draft guidance documents issued by CDRH. They found more than 90 proposed guidances that have never been finalized, including many that have been languishing for more than five years.

“Once FDA publishes a proposed guidance, for the most part, they've accomplished what they want to accomplish, which is letting everyone know what they think,” says Bradley Merrill Thompson, a member of the firm and leader of its medical device regulatory practice. “The step then of listening to public comments and making revisions is of interest to the public but obviously not so much to the agency. It ought to really rankle people to know that FDA puts this stuff out in draft form and often begins
to use it regardless of the comments received.”

One solution Epstein Becker & Green is proposing is that draft guidance documents be discarded after a year if they haven't been finalized.

See the inforgraphic below for more insights from the law firm's analysis.

(click to enlarge)

Jamie Hartford, managing editor, MD+DI

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