FDA needs to improve medical device regulation, GAO says

FDA is lacking performance metrics when it comes to tracking whether its medical device regulators are following a “least burdensome” approach toward asking applicants for additional information, according to a new report from the U.S. Government Accountability Office.

The GAO says in the report highlights: “Until such measures are developed and used, FDA will not be able to evaluate whether it effectively and consistently applies a least burdensome approach in its medical device reviews.”

Dr. Scott Gottlieb, FDA’s commissioner, said in a statement yesterday that he agreed with the GAO that there needs to be an evaluation of whether the agency is properly implementing the more than 20-year-old least burdensome provisions from Congress.

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