Devices

Performance Criteria for 510(k) Equivalence

FDA has published a draft guidance, Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria, with the agency’s current thinking on expanding use of the abbreviated 510(k) program for demonstrating substantial equivalence for premarket notification (510(k)) submissions. “The intent of the guidance is to describe an optional 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,” the document says…. “This guidance focuses on the prong 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 agency says it is aware that in some cases, demonstrating substantial equivalence through direct comparison testing may create burdens for 510(k) submitters that can be avoided. The guidance expands the potential use of the abbreviated 510(k) program by explaining how substantial equivalence for certain device types may be demonstrated in a way that is less burdensome but at least as robust.

“Use of this expanded program may also streamline the review of 510(k) submissions,” it says, “thereby reducing burdens on the agency and possible review times for individual submissions. In addition, this approach could facilitate healthcare professionals and patients making better informed decisions by ensuring that a device cleared through this pathway meets a transparent set of performance criteria. At the same time, this approach satisfies the statutory standard for demonstrating substantial equivalence.”

FDA says it believes that using performance criteria is only appropriate when the agency has determined that (1) the new device has indications for use and technological characteristics that do not raise different questions of safety and effectiveness than the identified predicate; (2) the performance criteria align with the performance of one or more legally marketed devices of the same type as the new device; and (3) the new device meets the performance criteria.

All performance criteria for use of the expanded abbreviated 510(k) program will be publicized through guidance developed for the program.

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