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New Bill Introduced to Streamline 510(k) Process

NEW YORK (360Dx) – Two members of the US House of Representatives introduced a bill today that calls for amending the Federal Food, Drug, and Cosmetic Act "to provide an alternative standard for substantial equivalence determinations for devices, and for other purposes."

Reps. Mimi Walters (R-Calif.) and Ami Bera (D-Calif.) introduced the bill. In a statement, Walters said that "[t]he improvement of medical care is due in large part to the innovation of the instruments and devices that carry out the procedures that keep us healthy. Unfortunately, unnecessary regulations hinder progress on new advancements that could save and improve lives."

The legislation would seek to simplify "repetitive and burdensome regulations in the review process for certain low- to moderate-risk medical devices," and allow the FDA to clear certain Class II medical devices "that comply with objective, published criteria developed by [the] FDA," she added.

AdvaMed, a group representing the interests of diagnostic and device makers, commended the introduction of the bill. Its President and CEO Scott Whitaker said in a statement that the alternative approach to providing 510(k) clearance proposed by the bill “does nothing to change FDA’s robust requirements, but would allow a more efficient process for both the agency and product sponsors."

Whitaker noted that the FDA has developed special controls and other guidance that lay out specific testing and performance requirements for several low- to moderate-risk devices so that they can "be deemed safe and effective and receive marketing clearance."

However, with the current review process, the FDA can't clear devices solely based on their satisfying these requirements, he said, adding that the process requires that product sponsors prove their devices are also substantially equivalent to a device currently on the market.

"This means that FDA must review duplicative and redundant information, which is inefficient and delays patient access to needed advancements," Whitaker added.