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Early Signs Positive From FDA's Least-Burdensome Training

 
• By David Filmore

An initial evaluation of US FDA's congressionally mandated staff training programs on "least burdensome" processes are promising, the agency says, but more time is needed to track data on more tangible positive impacts for device companies. Industry, meanwhile, will likely need more convincing.

Last fall, US FDA launched a staff training program on "least burdensome" approaches. An initial evaluation of the program by the agency shows the training has increased reviewer knowledge on the topic and led to perceived process improvements by reviewers. But it is too early to quantify review-process improvements based on the training, FDA said in a report to Congress.

The training program was mandated by the 2016 21st Century Cures Act to help improve FDA's application of least burdensome, a concept that has been embedded into device pre-market review...

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