Part of the work in modernizing the 510(k) device approval pathway, first established by congressional amendment of the FD&C Act in 1976 and updated in subsequent amendments, is an examination of how comparison of new devices to older (predicate) devices promotes patient safety. The 510(k) pathway is used for the majority of device submissions, and approximately 20% of devices cleared through this pathway from 2015-2018 relied on comparison to predicate devices that were more than 10 years old. This is somewhat like comparing your modern cellular phone to phones on the market prior to the launch of the first iPhone (which was released in 2007). In particular, older predicates may not meet current standards for cybersecurity, interoperability, biocompatibility and usability engineering. In a statement released in late November 2018, Commissioner Scott Gottlieb noted that the agency intends to use its authority (with public feedback) to move the market toward the use of more modern devices as predicates. We should expect to see more information on this effort in 2019.

Text Copyright © 2018 Katrina Rogers