The agency wants to steer companies to use newer devices for their comparable devices in 510(k) applications and is considering prohibiting medical device companies from citing products that are more than a decade old.
The FDA will ask devicemakers whether it should post a list of products or manufacturers that have scored market clearance based on predicates that came to market more than 10 years before.
"We believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device, promote greater competition to adopt modern features that improve safety and performance, and help make sure that newer devices reflect more modern technology and standards that can improve patient care and outcomes," Gottlieb and Shuren said.
But devicemakers say it still makes sense to cite these older products if the technology hasn't substantially changed over time.
"The proposed 10-year cutoff criteria could prove arbitrary as older predicates can offer extensive data about their performance, which helps sponsors introduce newer, safer devices," Scott Whitaker, CEO of the Advanced Medical Technology Association, said in a statement.
The agency also wants to launch a new pathway next year that would allow new iterations of commonly used medical devices to receive regulatory clearance based on how well they meet safety and efficacy objectives, instead of comparing them with other devices.
The 510(k) process has been under fire in Washington circles for years, as some allege the quick process has allowed some unsafe products to reach consumers.
A notable example is vaginal surgical meshes, which have been linked to numerous cases of chronic pain, infection and pelvic organ prolapse. Most of the mesh brands associated with the adverse events were cleared through the 510(k) process.
In 2011, the National Academy of Medicine, a health advisory group to the federal government, urged the FDA to replace the pathway with a new one.
The FDA asked the group whether the 510(k) process protected patients and promoted innovation in support of public health. The group said it was difficult to answer those questions since the pathway was not intended to determine whether a device was safe or effective. Instead, Congress created it to determine whether a new device is substantially equivalent to one already on the market, it said.
Around 80% of the devices coming on the market each year go through the 510(k) process. Nearly 20% of those products now in use were cleared based on a predicate that's more than 10 years old, according to the agency.
