US FDA best practices for initiating early feasibility studies for neurological devices in the United States

This article describes the efforts of the US Food and Drug Administration (FDA) Office of Neurological and Physical Medicine Devices to facilitate early clinical testing of potentially beneficial neurological devices in the US. Over the past 5 years, the FDA has made significant advances to this aim by developing early feasibility study best practices and encouraging developers and innovators to initiate their clinical studies in the US. The FDA uses several regulatory approaches to help start neurological device clinical studies, such as early engagement with sponsors and developers, in-depth interaction during the FDA review phase of a regulatory submission, and provision of an FDA toolkit that reviewers can apply to the most challenging submissions.

Automated summary

This article discusses the efforts made by the US FDA Office of Neurological and Physical Medicine Devices to facilitate early clinical testing of neurological devices. The FDA has developed best practices and encouraged developers to conduct their studies in the US, using various regulatory approaches such as early engagement with sponsors, in-depth interaction during the review phase, and provision of an FDA toolkit.