The FDA announced plans to modernize the 510(k) pathway, the most common mechanism by which new medical devices are brought to market. The main change will be in the selection of predicate devices, evolving a rule that has been in place since broad legislation defining the agency’s authority was enacted in 1976. Historically, the 510(k) clearance process requires “substantial equivalence” to a device that was marketed prior to 1976, and the agency reports in their press release that approximately 20% of 510(k)s cleared today are based on predicate devices that are more than 10 years old. The new FDA plan will help ensure that the 510(k) pathway incorporates the latest science and technological advances by promoting the use of more recent predicates. The initiative will be open for public comment, particularly on the proposal that the agency will make public on the CDRH website cleared devices naming predicates that are more than 10 years old, “whether other criteria should inform our point of reference”, and “whether there are other actions we should take to promote the use of more modern predicates.”
FDA Commissioner Scott Gottlieb and Director of the Center for Devices and Radiological Health Jeff Shuren stress that they don’t believe that 510(k)s naming older predicates are unsafe, but instead they believe their approach favors innovation and a focus on how to best serve physicians, patients and other stakeholders. Namely, FDA believes that more modern predicates will help providers and patients “choose among older and newer versions of a type of device”, “promote greater competition to adopt modern features that improve safety and performance” and ultimately enable the newest devices to adhere to and advance the latest performance standards – all in the name of improving patient outcomes.
This is just the latest step in the FDA’s effort to modernize device regulation. The agency previously announced plans better incorporate real world evidence in regulatory decision-making; to modernize the De-Novo pathway for low to moderate risk novel devices; to enable the use of rigorous, consensus objective criteria to serve as a predicate for future clearances; to build a national patient safety net; to re-envision a regulatory paradigm for digital health products and in vitro diagnostics; and to chart a premarket review path for breakthrough products.