The Food and Drug Administration (FDA) on January 22 posted a new, more-or-less final plan to change the 510(k) medical device process, pending public comments.
The plan follows the outline in a November 26, 2018 joint statement from FDA Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren. The basics are:
- Expanding and renaming the “abbreviated” 510(k) program
Under this little-used program, a manufacturer can demonstrate substantial equivalence through performance criteria instead of comparing a device to a predicate device. FDA issued a draft version of its proposal to expand this alternative April 12, 2018, calling it the “Safety and Performance Based Pathway.” An updated version of the April 12 proposal was posted January 22, 2019 with an issuance date in the document of February 1, 2019.
- Moving the device industry away from older predicates for traditional 510(k)s
In a separate action, FDA is asking whether it should pressure device manufacturers into basing 510(k) applications on predicate devices newer than 10 years old.
A first step in this plan would be to post on the FDA website a list of 510(k)-cleared devices which used devices older than 10 years as their predicates for demonstrating substantial equivalence.
“The Agency is considering focusing on predicates that are more than 10 years old as a starting point, so that the public is aware of those technologies. FDA’s goal in focusing on older predicates is to encourage sponsors to continually offer patients devices with the latest improvements and advances.”
In addition, FDA is asking for input on “other and/or alternative actions we should take to promote the development and marketing of safer, more effective 510(k) devices.”
Also, the agency is asking whether it should request authority from Congress to take actions such as completely banning some older devices as predicates.
The plan has sharp critics on both sides of the debate
FDA regulatory attorney Mark Duval warned clients in a recent, detailed memo to get ready for “increased product complexity and risk aversion” from the FDA. Shuren and his team “disdain” the 510(k) clearance program and are intent on sweeping changes, our legal reporter Walter Eisner reports in his January 9 Orthopedics This Week story, “FDA Forecast and Analysis for 2019.”
However, in a January 4 article titled, “The FDA is still letting doctors implant untested devices into our bodies,” Washington Post reporters Jeanne Lenzer and Shannon Brownlee, wrote disdainfully that “According to the FDA, the ‘most impactful’ change it is considering is recommending (not mandating) that companies cite predicate devices no older than 10 years.”
“Even a damning 2011 report by the Institute of Medicine (requested by the FDA), which deemed the agency’s 501(k) pathway so flawed it should be thrown out, fell on deaf ears,” the reporters wrote.
Actually, that report didn’t fall on deaf ears at all, Mark Duval said in his memo to his clients. “That attempt,” led by Shuren, “was met with a huge industry counter- movement.”
