Food and Drug Association Approval Process for Devices Used in Endovascular Treatment of Stroke.

Abstract

This article reviews the Food and Drug Administration's (FDA's) process for approval of new medical devices and describes the evolution of endovascular devices used for the treatment of acute ischemic stroke. Several recent studies have established the benefit of endovascular treatment of acute ischemic stroke from emergent large vessel occlusion. This has led to endovascular treatment becoming the usual care in acute stroke management and has generated greater-than-ever interest in the development of newer and more effective devices. In the United States, the FDA is the regulatory authority that is empowered with the approval and monitoring of new medical devices for widespread use in the population. The FDA categorizes medical devices into 3 classes based mainly on their potential risks to patients and/or users; class I devices pose the least risk and have the least stringent approval process, while class III devices pose the highest risk and undergo the most stringent and time-consuming approval process. There are 4 main pathways to approval: premarket notification, also known as the 510(k) pathway; premarket approval (PMA), de novo, and Humanitarian Device Exemption pathway. These pathways are described in detail in the article. The FDA also mandates postmarketing surveillance to identify any untoward and unexpected long-term complications.