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.

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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.

The new pathway would be voluntary and manufacturers could opt to continue to use the current 510(K) evaluation pathway.

Regulatory processes for the agency have remained relatively the same since its first implementation about 40 years ago, Gottlieb wrote. The 510(K) pathway for device approval, for instance, requires manufacturers to show a new device is substantially equivalent to similar devices already on the market and it demands comparisons to devices often up to 40 years old. 

“FDA recognizes that such direct comparison testing creates burdens for 510(K) applicants, especially when many new devices are designed in novel ways, using more advanced technologies,” Gottlieb wrote. “It’s sometimes hard to identify sufficient, appropriate predicate devices in order to conduct testing. This can create an obstacle to certain kinds of innovation and lead to inefficiency in the review process with few, if any, benefits to patient safety.”

The FDA will release its draft guidance on the new 510(K) pathway in the first quarter of 2018.

Twitter: @JessieFDavis
Email the writer: jessica.davis@himssmedia.com