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) neu