FDA’s Statement on Its Modernization of Its 510(k) Program

Jordan Lipp, Esq. |Attorney, Managing Member | Childs McCune

On November 26, 2018, the FDA released a statement on its views on the modernization of its 510(k) process. Historically, the 510(k) process is the FDA’s clearance of a medical device to be sold in the United States, if the FDA finds the device is substantially equivalent to a previously approved (or grandfathered in) device.

In the FDA’s recent statement, FDA Commissioner Scott Gottlieb, M.D. and Director of the Center for Devices and Radiological Health Jeff Shuren, M.D., explained that “[t]he most impactful way that we can promote innovation and improved safety in the 510(k) program is to drive innovators toward reliance on more modern predicate devices…” As such, they explained that they “believe that newer devices should be compared to the benefits and risks of more modern technology; that is why we’re looking at ways to promote the use of more recent predicates.” So, the FDA is considering putting on its website which cleared devices are based upon predicate devices that are more than 10 years old, and it is seeking public feedback on this plan.

The FDA is also planning in early 2019 to finalize guidance establishing an alternative 510(k) process, called the “Safety and Performance Based Pathway,” which will permit manufacturers of certain devices “to rely on objective safety and performance criteria to demonstrate substantial equivalence” based upon a contemporary baseline. The goal, as described by the FDA, is for the FDA and manufacturers to look to the future as opposed to looking to the past as the baseline for safety and efficacy.

The FDA’s statement also discussed the recent increase in the size of the 510(k) submissions, the increase in review time of these submissions while a simultaneous decrease in the time until clearance, and its actions in “up-classifying” certain devices from Class II to Class III (i.e., taking an existing device out of the 510(k) process and requiring the more vigorous Class III premarket approval.) For those in the industry, the six-page long statement, linked here, is worth reviewing.

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