As US FDA looks to revise its 501(k) process, the agency is considering a variety of reform proposals, not all of which are being embraced by regulations experts. One such scenario would see the agency sunsetting older predicate devices in an effort to promote the use of newer predicate devices, with an eye toward abandoning similar-device comparisons altogether and adopting new, performance-based criteria for 501(k) devices.  The idea was met with skepticism on the part of medical law and regulatory experts interviewed by Medtech Insight, who argue that such an approach would do little to alleviate the FDA’s main concerns.