FDA needs to improve medical device regulation, GAO says


FDAFDA 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.

“An effective and consistent least burdensome approach is essential for evaluating novel devices under FDA review as well as accommodating iterative improvements to existing devices already on the market,” Gottlieb said.

The GAO report could further bolster the efforts of Gottlieb, an appointee of President Donald Trump, to make the agency even more industry-friendly – easing application and malfunction reporting processes, for example, even as it continues to assure the safety and effectiveness of new devices.

It is presently tough to figure out whether FDA’s regulators are asking medical device companies for additional information in the least burdensome way, according to the Government Accountability Office. Between 2001 and 2016, FDA asked medtech companies for additional information for the majority of more than 62,000 submissions. But between 2013 and 2016, there were only 33 information request appeals related to the least burdensome requirements, with FDA agreeing or partially agreeing with 11 of the appeals.

The GAO, however, also reported that medical device industry representatives think the number of appeals may not fully represent the number of such disagreements. Said the report highlights: “Applicants are generally concerned that an appeal would damage their relationship with FDA and potentially negatively affect future device applications.”

The Government Accountability Office noted that FDA has recently taken steps to bolster the following of the least burdensome requirements. Most relevant staff have received training on least burdensome requirements since the 21st Century Cures Act was enacted in 2016, and FDA plans to conduct an audit of requests for additional information.

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