‘Legislation Needed to Move Away from Predicate-based’ 510(k)s
Legislation is needed to codify changes FDA is seeking to its medical device 510(k) program to reduce the reliance of equivalence to a predicate device and transition to a system where new devices demonstrate improved safety and effectiveness compared with marketed devices for the same clinical purpose, according to a new viewpoint on JAMA Network. The new clearance framework should rely on “meaningful clinical criteria to gain clearance,” and these criteria will differ based on the intended use of the device and should be “based on patient-oriented clinical outcomes,” the viewpoint says.
Late last year, FDA officials said (see story) they were examining ways to modernize the medical device 510(k) process by relying more on a review that weighs new technologies that improve device safety or performance and to “retire” outdated predicate devices that have been cited to demonstrate equivalence, “especially in cases where we’ve seen safer or more effective technology emerge.” And earlier this year, FDA released the guidance, Safety and Performance Based Pathway, that provided the agency’s current thinking on allowing 510(k) clearance for certain medical devices if the devices meet specific criteria, which should include safety and effectiveness (as opposed to the often ill-defined “substantial equivalence” to predicate devices).
The viewpoint authors note that because many safety issues are revealed once a product is in clinical use, postmarket surveillance for all medical devices must be strengthened. “The growing emphasis on priority review and shortening premarket time makes postmarket surveillance critical for safety and effectiveness,” they write. “Postmarket surveillance would be strengthened by time-limited conditional approval for medical devices of one or two years, with preplanned criteria that would need to be met based on postmarket data to ensure that the device met acceptable clinical safety and effectiveness thresholds to remain on the market. All device usage would occur only in the context of data collection from clinical practice settings. Although this is a challenging and complex task, the National Evaluation System for Health Technology (NEST) is being developed to assess the safety of devices in clinical practice settings.”
Most importantly, conditionally approved devices must be removed from the market if clinical evidence questions safety or effectiveness, the viewpoint says. “(P)re-determined clinically meaningful criteria would need to be met to ensure that a device could remain on the market,” it says. Additionally, data would need to be generated through preplanned clinical studies that examine all uses (both on label and off label). “If such data are not generated within a timely, agreed-on, and publicly available schedule, then the device’s conditional approval would end,” it adds.
The viewpoint says that any proposed legislation should require that 510(k) devices use this new pathway within five years.