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

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  • 1 Office of Health Technology 5, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration;
  • | 2 Office of Clinical Evaluation and Analysis, Center for Devices and Radiological Health, Food and Drug Administration; and
  • | 3 Office of Health Technology 2, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland
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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.

ABBREVIATIONS

CDRH = Center for Devices and Radiological Health; CFR = Code of Federal Regulations; DES = device evaluation strategy; EFS = early feasibility study; IDE = investigational device exemption.

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Contributor Notes

Correspondence Robert Herrmann: Food and Drug Administration, Silver Spring, MD. robert.herrmann@fda.hhs.gov.

INCLUDE WHEN CITING Published online June 4, 2021; DOI: 10.3171/2020.11.JNS203653.

Disclosures The authors report no conflict of interest concerning the materials or methods used in this study or the findings specified in this paper.

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