- Medical device manufacturers are urging FDA to not limit use of 510(k) predicates on the basis of the age of devices used as a reference product.
- AdvaMed, the largest medical device trade group, wrote in comments to the agency the current 510(k) regulatory pathway is appropriate. The lobby said that while it supports periodic review of the program, FDA already has the authority to up-classify devices to effectively remove eligibility as a predicate and to impose special controls on moderate risk devices.
- The Consumer Healthcare Products Association, Blue Cross Blue Shield Association, Medical Imaging & Technology Alliance and AdvaMed all urged FDA to not publish a list of devices based on age of predicates.
In January, FDA formally asked for feedback if it should publicly distribute information on older predicate devices as a method to encourage use of newer predicates or seek new authority to make some older devices ineligible as predicates.
Device center chief Jeff Shuren previously told MedTech Dive the agency was waiting until the comment docket closed before deciding on next steps, but it does not appear the agency is poised to pursue a rigid cut-off age for eligible 510(k) predicates.
"It's not the idea that we're enamored with; it is trying to nudge the industry more and more to keep making better products," Shuren said.
In May, Marjorie Shulman, the assistant director of 510(k)s at FDA, said at the Food and Drug Law Institute's annual conference such an idea would have unintended consequences for devices that do not evolve over time.
Between 2015 and 2018, approximately 20% of 510(k) applications were cleared based on a predicate older than 10 years old, according to FDA.
AdvaMed said instead of limiting use of older predicates, FDA should issue additional guidance documents and work with companies as they select the predicate for a new product.
"FDA should have objective evidence that a fundamental change to the 510(k) process, such as limiting the use of older devices as predicates, would improve the program before seeking new legislative authority," Ruey Dempsey, AdvaMed vice president of technology and regulatory, said in the group’s comment.
Johnson & Johnson, one of the largest medical device manufacturers, told FDA that an "arbitrary time-based criterion" ignores the length of a product development cycle, which the company said can last up to five years, and the time for the market to start using a new device.
"Johnson & Johnson believes that highlighting the age of predicate devices will not contribute to the development and marketing of safer, more effective 510(k) devices," Philip Desjardins, J&J vice president of global regulatory affairs policy & intelligence for medical devices, wrote in the company’s comment. "In fact, doing so may result in negative unintended consequences."
It does not appear FDA is poised to issue regulations that would overhaul the 510(k) program this year; the new Spring 2019 Unified Agenda does not list any such plans.