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Medical Devices / Regulatory Affairs

GAO Calls on FDA to Develop Metrics for Least Burdensome Requirements

Jan. 23, 2018
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The FDA needs to develop performance metrics to assess the implementation of its least burdensome requirements, according to the Government Accountability Office.

The agency’s requirements under the policy direct it to use the least burdensome principles — outlined in a December 2017 draft guidance — during regulatory actions, such as auditing deficiency letters sent to medical device sponsors to identify issues in premarket submissions.

Agency staff has received training on using the approach since at least 1997, FDA Commissioner Scott Gottlieb said in a response to the GAO report, adding that 90 percent of employees have been trained in this area.

However, the agency “has not specifically evaluated implementation of the least burdensome requirements,” according to the GAO. It also has not yet developed performance metrics to conduct this type of evaluation.

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