Postmarket Modifications of High-Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration

Abstract

Objective:

The US Food and Drug Administration (FDA) grants initial marketing clearance for novel high-risk medical devices via the premarket approval (PMA) pathway, which requires clinical data demonstrating safety and effectiveness. Manufacturers may subsequently file supplemental PMA applications (supplements) to implement incremental device changes, usually without additional clinical data. Given the potentially significant clinical implications of using new device models, this study characterized the frequency and nature of changes to high-risk therapeutic otolaryngic devices cleared via the PMA pathway.

Study Design:

Retrospective cohort study.

Setting:

FDA PMA database.

Methods:

Original high-risk therapeutic otolaryngic devices and supplements were identified. Supplements were characterized by clearance date, change type, and review track, including real-time (design-minor) and 180-day (design-major) tracks. Median device lineage life span (postmarket period over which changes occurred) and median number of changes per original device were calculated.

Results:

Through 2014, the FDA cleared 14 original high-risk therapeutic otolaryngic devices via the PMA pathway and 528 incremental changes via supplements. Devices were modified over a median 10.5-year life span (interquartile range, 4.4-15.8; range, 0.7-24.1), and they underwent a median 22 changes (interquartile range, 10-70; range, 2-108). Over half (272 of 528; 52%) altered device design, most of which were reviewed via the 180-day track (199 of 272; 73%) intended for major design changes. Few real-time design changes (11 of 73; 15%) were designated by the FDA as “minor.”

Conclusion:

A substantial number of incremental changes have been made to high-risk therapeutic otolaryngic devices over time, including many major design changes without supporting clinical data.