FDA Guidance Looks to ‘Modernize’ 510(k) Premarket Clearance Program


Posted April 17, 2018

The Food and Drug Administration (FDA) has issued draft guidance intended to “modernize” the agency’s approach to clearing moderate-risk devices by establishing an expanded version of the FDA’s longstanding Abbreviated 510(k) program. The new program will allow medical device manufacturers to compare the performance of new devices to FDA-identified criteria rather than measuring them directly against previous device designs.

“The development of medical devices often includes iterative improvements over previous devices, and these small advances can enhance their overall safety and effectiveness. The aim of our review policies is to facilitate this sort of helpful evolution in product performance to benefit patients,” said FDA Commissioner Scott Gottlieb in a statement. “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.”

According to the draft guidance, Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria, rather than directly comparing the performance of new devices to previous ones—called predicates—medical device manufacturers would instead be able to demonstrate that their devices meet FDA-identified performance criteria by submitting a declaration of conformity and/or a summary of the data or the underlying data. Such criteria could include FDA-recognized consensus standards or criteria established within FDA guidance documents. The program also will rely on “the experience and expertise of FDA staff, information in literature, and analyses of data on existing devices within a device type,” according to the draft guidance.

In an FDA Voice blog posted late last year, Gottlieb noted that this new framework would “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.

 “If a device cannot rely entirely on performance criteria identified by FDA to demonstrate substantial equivalence for its submission, it is not appropriate for this program,” the guidance document states. Previously established 510(k) programs that compare a new medical device against predicates will remain available, the FDA said, and the new program is voluntary.

The FDA said it would maintain a list of eligible devices and provide information about applicable performance criteria, testing methods, and other relevant information on its website.

Comments on the expansion of the Abbreviated 510(k) program can be submitted via www.regulations.gov until July 11.