On November 26, 2018, the Food & Drug Administration (FDA) announced its intent “to modernize the FDA’s 510(k) clearance pathway”1 by encouraging manufacturers to rely on newer (that is, 10 years old or less) medical devices as predicate devices in 510(k) notifications, and providing an alternative 510(k) pathway that allows manufacturers to rely on objective safety and performance criteria, at least for certain well-known devices. This revised approach comes at a time when advances in technology are rapidly outpacing FDA’s ability to review and clear new medical device technology for market. FDA has also come under increasing criticism in recent years for failing to detect problems in certain medical devices, which have, in some instances, caused injuries to consumers. FDA believes that this new approach will improve medical devices’ safety and performance, and expects hope that this new pathway will become the norm for approval of medical devices.
While the plan’s specifics remain to be seen, FDA’s new approach has the potential to greatly impact medical device manufacturers’ plans for the future. Below, we describe FDA’s plans for encouraging reliance on newer predicate devices and objective safety and performance criteria.
Reliance on Newer Predicate Devices
FDA has set forth a two-prong approach for its modernization efforts. First, FDA will encourage manufacturers to designate newer medical devices as predicate devices for comparative purposes in 510(k) clearance notifications. The agency believes that older predicate devices may not reflect accepted technological advancements or understanding of a device’s safety and efficacy profile. FDA proposes that newer devices should serve as the predicates because older devices may not be the best comparison the modern technologies incorporated into the newer devices.
To achieve this, FDA is considering publishing a list of cleared devices that rely on technologies that are more than 10 years old, so that patients and physicians can compare and decide between older and newer commercial devices. Presumably, FDA believes preference will skew toward newer devices, and that this will encourage applicants to rely on newer devices as the predicates. While the agency states that it will not remove older devices from the market, as it continues to maintain that older devices remain safe to use, it is clear that FDA believes (and hopes) that this new approach will lead to the use of newer technologies in medical devices.
There are still some specifics FDA will need to determine, possibly through guidance documents. For example, FDA does not address how it will define technologies that are more than 10 years old, which may be difficult because technologies often evolve gradually through multiple iterations. FDA intends to seek public comment before publishing the list of cleared devices that relied on “older” technology predicates.
“Safety and Performance Based Pathway”
Second, FDA plans to introduce a new 510(k) clearance pathway in early 2019 that will allow manufacturers to demonstrate a device’s safety and efficacy by comparing the device against modern performance criteria instead of against a predicate device. Again, FDA’s rationale is similar – FDA believes the current reliance on older predicates may be hampering innovation. It is difficult to compare a new device with modern technologies against much older devices that lack similar technology.
To enable this pathway, FDA will establish a “contemporary baseline that looks to the future; one that can be updated as technologies advance,” against which new devices can be compared. This new pathway, possibly to be called the “Safety and Performance Pathway” – would be based on “established or recognized” standards. At first, the agency will only make this pathway available for “certain well-understood device types.” FDA believes that this new pathway will eventually become the primary pathway for 510(k)-cleared devices.
We intend to monitor FDA’s modernization efforts moving forward and will continue to provide updates on FDA’s actions in this area. Manufacturers and other interested stakeholders are encouraged to submit comments to FDA on its upcoming plans to publish a list of cleared devices relying on “older” technologies when that comment period opens. In addition, manufacturers planning to submit 510(k) notifications in the near future should keep a close eye on developments with respect to FDA’s new pathway.
- See FDA Statement: Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuran, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 501(k) program to advance the review of safety and effectiveness of medical devices, Nov. 26, 2018, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626572.htm.