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Mark E. Brager
May 18, 2017

New 510(k) Approach Would Leverage FDA Objective Criteria

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker following introduction of legislation (H.R. 2474) in the U.S. House of Representatives that would create an alternative review approach for low- to moderate-risk medical devices and diagnostics:

“FDA has developed ‘special controls’ and other guidance for a number of low- to moderate-risk devices that lay out specific testing and performance requirements in order for these devices to be deemed safe and effective and receive marketing clearance.

“Unfortunately the current review process does not allow the agency to clear devices solely based on such requirements and necessitates product sponsors to prove their devices are also substantially equivalent to a currently marketed device. This means that FDA must review duplicative and redundant information, which is inefficient and delays patient access to needed advancements.

“AdvaMed commends Reps. Mimi Walters (R-Calif.) and Ami Bera (D-Calif.) for introducing legislation which will establish an alternative review approach for a subset of moderate-risk Class II devices. This new approach will allow the agency to grant 510(k) clearance based solely on compliance with objective, published criteria developed by FDA.

“This alternate approach does nothing to change FDA’s robust requirements, but would allow a more efficient process for both the agency and product sponsors. We look forward to working with Congress, FDA and other stakeholders to advance this legislation.”