FDA to streamline, clarify medical device review process

The FDA will enact a 25-point action plan this year to streamline the de novo review process for certain lower-risk medical devices, as well as clarify the premarket notification submission process, which critics had called “unpredictable” and not “robust enough,” according to an FDA press release.

These actions will produce “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe and effective technologies to patients quickly,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health (CDRH), said in the release.

According to the action plan, the FDA plans to clarify which device changes require a new premarket notification submission — called a 510(k) — and which changes are eligible for a Special 510(k). Other plans include clarifying when clinical data should be submitted in support of a 510(k), establishing a Center Science Council to ensure timely and consistent science-based decision-making and formalizing the Center’s process for assessing staffing shortages. The entire 25-point action plan is available here.

The plan is the product of two internal working groups created by the CDRH in response to complaints about the 510(k) review process by industry, consumers and health care professionals. The CDRH has also requested a review by the independent, nonprofit Institute of Medicine, the results of which are expected in April.

“We look forward to implementing these changes in support of our overall mission: improving the health of the American public,” Shuren said in an open letter to the public.

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