On February 1, 2019, FDA issued a final guidance[1] establishing an optional 510(k) pathway for certain well understood devices. This “Safety and Performance Based Pathway,” an expansion of the longstanding Abbreviated 510(k) program, is part of FDA’s ongoing effort to modernize and strengthen the 510(k) program.

The pathway will continue to require the identification of predicate devices for the intended use and technological characteristics decision points of the substantial equivalence analysis. But under the new approach, manufacturers of certain device types would demonstrate substantial equivalence through FDA-established or FDA-recognized objective safety and performance-based criteria that reflect current technological principles. Instead of reviewing data from direct comparison testing between two devices, FDA would support a finding of substantial equivalence based on data showing the new device meets the level of performance of appropriate predicate devices.

The performance criteria for a specific device type may be described in FDA guidance, FDA-recognized consensus standards, and/or special controls. Use of performance criteria will only be appropriate when FDA determines 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 all the performance criteria.

FDA will detail the types of devices and the applicable performance criteria for the Safety and Performance Based Pathway in future guidance, and intends to maintain a list of device types appropriate for the pathway on the FDA website.

FDA described the alternative pathway as providing a less burdensome (but still robust) way to demonstrate substantial equivalence, and expressed hope that it would make review of 510(k) submissions more efficient, thereby reducing burdens on FDA and review times for individual submissions. Although direct comparison of a new device with a legally marketed device will remain available under a Traditional or Special 510(k) pathway, FDA’s long-term goal is for the Safety and Performance Based Pathway to become the primary framework for devices eligible for 510(k) review.

This newly issued guidance is just one part of FDA’s Medical Device Safety Action Plan, through which the Agency seeks to encourage medical device manufacturers toward reliance on robust performance criteria and more modern predicate devices. The Action Plan reflects FDA’s concern that older predicate devices might not closely reflect the modern technology embedded in new devices, or a current understanding of device benefits and risks.

Other components of the Medical Device Safety Action Plan are in progress. For example, FDA is currently accepting comments regarding its proposal to make public on its website which cleared devices demonstrated substantial equivalence to predicate devices that are more than 10 years old.

[1] The draft guidance, issued April 12, 2018, was titled “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria.” FDA said the changed title reflects the Agency’s focus on advancing improved safety and performance of new products.