FDA Moves to Improve Device Safety Through Safer Designs

The Agency intends to focus more of its policies on supporting developers that pursue safer devices, he said.

As part of its new Medical Device Safety Action Plan the agency raised the possibility of providing an approval path for safer devices that don’t meet its Breakthrough Program criteria but are intended to be safer than current technologies on the market.

Under the new program, “…we’d provide greater interactions with developers and grant expedited review to their products where the key advantage is their enhanced safety over existing devices,” he said. “We also want to make it easier for medical device manufacturers to make comparative safety claims about their products…”

REFERENCE:  FDA News Device Daily Bulletin (Medical Devices/Regulatory Affairs); 15 MAY 2018