New ways to identify "predicate creep" for improving the FDA’s 510K process for clearing medical devices

Are there new ways to identify potential “predicate creep” —a cycle of technology change through repeated clearance of devices based on predicates with slightly different technological characteristics— in order to improve the FDA’s 510K process for clearing medical devices?

A newly published paper by Sandra Rothenberg, Chair of the RIT College of Liberal Arts Department of Public Policy, and RIT alum Charlotte Lefkovich (Mech Engineering BS and Science, Technology, and Public Policy MS) asserts it can.

Their research found a new way to identify potential predicate creep through the use of product codes and regulatory classifications, a method they tested by applying it to a case study of a Robotic Assisted Surgery (RAS) device, the Intuitive Surgical Da Vinci Si Surgical System.

Published March 28, 2023 by Plos One, their research article discusses implications of this method for research and policy. Read more »