Devices

Safety, Performance Based Pathway Guidance

FDA has issued a guidance, Safety and Performance Based Pathway, with the agency’s current thinking on expanding the concept of the abbreviated 510(k) program for demonstrating substantial equivalence for 510(k) submissions. The document’s intent is to describe an optional pathway (the Safety and Performance Based Pathway) for certain, well understood device types, where a submitter would demonstrate that a new device meets FDA-identified performance criteria to demonstrate that the device is as safe and effective as a legally marketed device.

“This guidance focuses on the decision point of the substantial equivalence analysis that requires a 510(k) submitter to demonstrate that, despite technological differences, its device is as safe and effective as a legally marketed device,” the guidance says. “FDA recognizes that, in some cases, demonstrating this through direct comparison testing may create greater burdens for 510(k) submitter than applying an alternative approach, such as the approach described in this guidance, if appropriate.”

In a statement, FDA commissioner Scott Gottlieb and CDRH director Jeffrey Shuren say the new pathway “will ensure that the performance characteristics of new devices are evaluated against a set of objective, transparent, and well-validated safety and performance metrics. It’s important to note that devices using this pathway will still have to meet our current standards for reasonable assurance of safety and effectiveness before they can be marketed. The benefit of this approach is that the pathway will benchmark modern technology against modern standards while, at the same time, offering a potentially more efficient way to demonstrate that a new device is substantially equivalent to devices already on the market, and thereby ensure patients have timely access to beneficial products.”

The two say the agency also is soliciting public comment on steps that could be taken to further encourage medical device manufacturers to develop innovations that enhance the safety of 510(k) devices. One possible approach, they write, would be to focus on using more modern predicate devices.

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