After more than four decades, the Food and Drug Administration has announced it will modify its clearance process for medical devices.
The FDA’s 510(k) clearance pathway currently accounts for the majority of the devices the FDA reviews (82 percent) and relies heavily on comparisons with products on the market, according to a statement from FDA Commissioner Scott Gottlieb. The changes aim to "keep pace with the increasing complexity of rapidly evolving technology," the statement notes, changes that often make it more difficult to review the safety and effectiveness of new tech.
"We believe firmly in the merits of the 510(k) process. But we also believe that framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices," the statement reads.
The new process will scrutinize medical devices that come to market under the 510(k) pathway to ensure they "either account for advances in technology or demonstrate that they meet more modern safety and performance criteria." At the same time, the FDA will seek to "retire outdated predicates, especially in cases where we’ve seen safer or more effective technology emerge."
The agency plans to issue new guidance that will allow devices to get to market via "objective safety and performance criteria” by early 2019.