Identification of predicate creep under the 510(k) process: A case study of a robotic surgical device.

Abstract

The FDA's 510(k) process for medical devices is based on "substantial equivalence" to devices clearedpre-1976 or legally marketed thereafter, known as predicate devices. In the last decade, several high-profile device recalls have drawn attention to this regulatory clearance process and researchers have raised questions about the validity of the 510(k) process as a broad clearance mechanism. One of the issues raised is the risk of predicate creep, a cycle of technology change through repeated cl