Regulatory Framework for Implantable Neurostimulation Devices: Comparison of Systems in the US and European Union.

Abstract

Implantable neurostimulation devices must be authorized before they are placed on the market. For this purpose, requirements, and processes for assessing their fulfillment, have been defined in different jurisdictions. In this study, we aimed to address differences between the US and European Union (EU) regulatory systems and their relationship to innovation. A literature review and analysis were conducted using legal texts and guidance documents. The US system has one central body, the Food and