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FDA Employee Assessments Don’t Always Include User Fee Performance Goals

Agency’s device center holds many reviewers to user fee pre-market time goals as part of employee performance reviews, but the goals are not explicit components of the CDRH director’s performance plan, an inverse approach to that of FDA’s drug center, according to the Government Accountability Office.

Meeting user fee performance goals is an explicit factor in evaluating the performance of many FDA device reviewers and mid-level managers, but it is not in the performance plan for the CDRH director, according to the Government Accountability Office.

GAO examined documentation detailing performance standards for employees at CDRH, as well as at the drug and biologics centers of FDA, at the request of Sens. Richard Burr, R-N.C., and...

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