On April 12, the FDA released draft guidance discussing an expansion of its Abbreviated 510(k) program for medical devices. This new guidance would allow a submitter to establish substantial equivalence by demonstrating that a new medical device meets certain performance criteria, rather than by submitting direct comparison testing against a predicate device. The intention of the Expanded Abbreviated 510(k) program is to increase the efficiency and efficacy of the 510(k) program for device manufacturers, the reviewing agency, and healthcare professionals and patients alike.
What Is the Expanded Abbreviated 510(k) Program?
Under the 510(k) program, a medical device can be cleared by the FDA if it is found to be substantially equivalent to a predicate device. This guidance aligns with Congress’s amendment in section 513(i)(1)(D) of the FD&C Act to ensure that FDA considers the least burdensome means of demonstrating substantial equivalence.
This guidance addresses the prong of the substantial equivalence analysis that requires a submitter to demonstrate that, despite technological differences, its medical device is as safe and effective as a legally marketed device.
Under the Abbreviated 510(k), a submitter may use conformity to FDA standards, guidance, or special controls to demonstrate some of the performance characteristics necessary to support a finding of substantial equivalence. The Expanded Abbreviated 510(k) program, announced in this guidance, would allow the user to demonstrate all of the performance characteristics to establish substantial equivalence. Read more ›