Making changes to a regulatory process is usually difficult, slow, and often painful — after all, it involves lots of bureaucracy and many “cooks in the kitchen.” But I’m encouraged by FDA’s recent announcement that it plans to modernize the 510(k) pathway. In today’s culture of connectivity, smartphones, artificial intelligence, and exploding innovation in materials and manufacturing, it’s time to give the 42-year-old process an overhaul.
Key to this modernization is FDA’s decision to retire outdated predicates, making sure that new devices are evaluated against advances in technology.
“We believe that framework needs to be modernized to reflect advances in technology, safety, and the capabilities of a new generation of medical devices,” say FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the CDRH.
“The most impactful way that we can promote innovation and improved safety in the 510(k) program is to drive innovators toward reliance on more modern predicate devices or objective performance criteria when they seek to bring new devices to patients.”
Among the steps FDA is considering are some that are both innovative and bold, including making public on its web site those cleared devices that demonstrated substantial equivalence to older predicate devices. The focus would be on predicates that are more than 10 years old, in part to drive sponsors to continually offer patients devices with the latest improvements and advances.
In the future, FDA wants to find ways that encourage product developers to use more modern predicates to give patients and doctors a choice among older and newer versions of a type of device, as well as to “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.”
The agency is also developing proposals to potentially sunset certain older predicates and promote the use of more modern predicates. This approach, they say, accounts for the advances in newer devices such as interoperability and robotics.
FDA plans to seek public feedback on whether it should make public devices or manufacturers who make technologies that rely on predicates that are more than 10 years old, whether other criteria should inform its point of reference, and whether there are other actions the agency should take to promote the use of more modern predicates.
In early 2019, FDA intends to finalize guidance establishing this alternative 510(k) pathway with a goal of making it more efficient to adopt modern criteria as the basis for the predicates that are used to support new products. The new approach, renamed “Safety and Performance Based Pathway,” will help ensure that new products can more easily reflect beneficial new advances.
Editor and Director of Medical Content
To learn more about the 510(k) modernization, read FDA’s statement here.