The current 510(k) regulatory review pathway for medical devices is poised for a significant overhaul, the U.S. Food and Drug Administration (FDA) announced this week. The proposal making the most headlines is that FDA aims to shift the industry towards medical devices that are 10 or less years old.
RAPS reports that the agency “believe[s] that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria… Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old.”¹ FDA suggests that recently cleared devices make for more appropriate benchmarks when companies preparing 510(k) submissions make comparisons to predicate devices. The Agency’s goal is to make the expanded Abbreviated 510(k) program the primary pathway for devices that require a 510(k).¹ FDA Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren explained that “to advance these goals, in the next few months CDRH is considering making public on its website those cleared devices that demonstrated substantial equivalence to older predicate devices.”¹ Gottlieb and Shuren went on to state that congressional support may be required to achieve the proposed changes.
Justifying the changes to the 510(k) program
FDA found that many predicates that have served as the basis to obtain FDA clearance were established nearly 40 years ago when the 510(k) review process was originally created by Congress, RAPS reports. Gottlieb explained that medical device manufacturers typically “rely on comparative testing vs. predicate devices to show a new device is as safe and effective as the predicate… But older predicates might not closely reflect the modern technology embedded in new devices or more current understanding of benefits and risks.”¹
Response to the Agency’s announcement on Monday thus far has been mixed. Some within the industry have applauded the move as a step towards further accelerating the 510(k) regulatory pathway, while others have expressed concerns for the safety of the end users: patients. Stay tuned to the Pearl Pathways blog in the coming weeks for a deeper dive into the implications the proposed changes will have on medical device companies by one of our medical device experts.