Government Healthcare Policy, Business and Technology

FDA to add new voluntary approval pathway for medical devices

Healthcare IT News: The U.S. Food and Drug Administration is planning to add a new voluntary, alternative pathway for medical devices, FDA Commissioner Scott Gottlieb, MD, announced Monday.

The flexible pathway will lean on more modern criteria for a reference standard and allow comparisons to standards that are more closely aligned with the particular technology FDA is being asked to evaluate.

The new framework will let device manufacturers demonstrate substantial equivalence by meeting objective performance and safety rules. Gottlieb said this will include FDA-recognized standards, guidance documents, or a combination of the two.

Further, the pathway will be available to pre-specified mature device categories that meet or exceed the safety and performance criteria of existing devices on the market. Gottlieb said the approach will make it easier for the agency to adopt a new product framework that meets international consensus standards.

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