United States Food and Drug Administration Approval of Neurosurgical Devices: A 25-Year Review of Non-510(k) Pathway Trends.

Abstract

Neurosurgical innovation increasingly relies on novel medical devices to advance the field. Low-risk devices follow the traditional 510(k) regulatory pathway for clearance; however, the U.S. Food and Drug Administration (FDA) offers other pathways; Premarket Approval (PMA), Humanitarian Device Exemption (HDE), De Novo, and Investigational Device Exemption (IDE) to provide market access for devices of different risk profiles. This study aims to provide the first characterization of non-510(k) neurosurgical device approval trends. Publicly available FDA databases were retrospectively queried for original neurosurgical device submissions approved through PMA, HDE, De Novo, and IDE pathways between January 2000 and July 2025. Devices were further categorized by participation in the Breakthrough Device Program (BDP), clinical function, and industry characteristics. Approval trends, pathway utilization, and review durations were analyzed. Across the study period, 93 neurological devices were approved via non-510(k) FDA pathways. De Novo was the most common pathway (52 approvals), and functional neurosurgical devices represented the largest category (27 devices). Approval volume increased notably after 2013. Across the examined non-510(k) pathways, the average time to approval was 451 days. BDP participating De Novo devices showed statistically significant shorter review durations compared to De Novo and PMA devices (p-value = 0.008 and 0.003, respectively). Medical device manufacturers have increasingly relied on non-510(k) regulatory pathways for neurosurgical devices in recent years. Increased utilization of these pathways will be integral to meet the increasing need for high-impact and more transformative technologies.