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Medical Devices / Regulatory Affairs

FDA Plans to Modernize 510(k) Clearance Pathway

Dec. 4, 2018

The FDA announced a proposed overhaul of its 510(k) review process that would begin with a shift in focus to predicate devices that are ten years old or less.

Commissioner Scott Gottlieb said the agency wants to promote the use of more modern predicates in order to compare devices to the benefits and risks of newer technology.

Almost 20 percent of current 510(k) clearances are based on predicates that are more than a decade old, meaning that they’re being compared to older technology during review and may not be seeing constant improvement, “the hallmark of health technologies,” Gottlieb said.

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