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August 20, 2018

FDA to offer a voluntary, more modern 510(k) pathway for enabling moderate risk devices to more efficiently demonstrate safety and effectiveness


Deborah Kotz,
FDA to offer a voluntary, more modern 510(k) pathway for enabling moderate risk devices to more efficiently demonstrate safety and effectiveness


FDA proposes a new option for 510(k) clearance that will modernize the FDA’s approach to moderate risk devices by allowing manufacturers to use objective performance criteria to facilitate demonstration of substantial equivalence of their new products to legally marketed devices.

“Right now, manufacturers often rely on comparative testing against predicate devices to show that a new device is as safe and effective as a predicate device. But these predicates can be old, and in certain cases, they might not closely reflect the modern technology embedded in new devices. By allowing a set of objective, transparent and well-validated performance metrics to serve as the benchmark for evaluating some new devices, this new pathway offers a more efficient and less burdensome option to demonstrate that certain new devices are substantially equivalent to ones already on the market,” said FDA Commissioner Scott Gottlieb, M.D.

The U.S. Food and Drug Administration published a draft guidance “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria” that provides the FDA’s proposed thinking on expanding the options for demonstrating substantial equivalence for premarket notification, called 510(k), submissions through the Abbreviated 510(k) program. The intent of the guidance is to describe a voluntary program for certain well-understood device types where, for the performance comparison aspect of substantial equivalence, a company would demonstrate that a new device meets FDA-identified performance criteria instead of directly comparing the performance of the new device to a specific predicate device.

Such criteria could include FDA-recognized consensus standards and criteria established by the FDA guidances. In an FDA Voice blog, Dr. Gottlieb noted that the voluntary pathway will “allow more flexibility to use more modern criteria as the reference standard and permit comparisons to standards that more closely approximate the kind of current technology” the FDA is being asked to evaluate.

Substantial equivalence is rooted in a comparison between a new device and a predicate device, which is a legally marketed device to which a new device may be compared because it has the same intended use and similar enough technological characteristics. But predicate devices are sometimes decades old. The FDA believes performance criteria can facilitate this comparison.

Under this approach, if a predicate device meets certain levels of performance on characteristics relevant to its safety and effectiveness, and a new device meets or exceeds those same levels of performance on the same characteristics, the FDA could find the new device to be as safe and effective as the predicate. Instead of requiring direct comparison testing between the two devices, the FDA could support a finding of substantial equivalence based on data showing the new device meets or exceeds the level of performance that is consistent with the performance profile of an appropriate predicate device.

The guidance, once finalized, could reduce regulatory burdens while maintaining standards for safety and effectiveness and providing patients and healthcare professionals with greater confidence that the device meets modern performance standards that reflect the complexity of more modern products. This approach could also facilitate health care professionals and patients making better informed decisions and give them greater confidence in the safety and effectiveness of devices cleared through this pathway because these devices would meet a transparent set of more up-to-date performance criteria.