Search Results

You are looking at 1 - 1 of 1 items for

  • Author or Editor: Vivek Pinto x
  • All content x
Clear All Modify Search
Restricted access

Robert Herrmann, Maureen Dreher, Andrew Farb, Michael Hoffmann, Christopher M. Loftus, Nina Mezu-Nwaba, Vivek Pinto, Xiaolin Zheng, and Carlos Peña

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.