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Strategies for reducing regulatory barriers to focused ultrasound technology

Background/introduction

The U.S. Food and Drug Administration (FDA) has automatically classified focused ultrasound (FUS) devices Class III, which requires sponsors to demonstrate the safety and effectiveness of a device through clinical trials. This requirement adds significant time and cost to the device development process; reclassification to Class II would be highly beneficial for the future of FUS.

Methods

Statute outlines two strategies for reclassifying FUS to a class with lower regulatory standards: filing a petition for reclassification based on new information and filing a de novo application to request a risk-based review of a novel technology.

Results and conclusions

There are three additional options for Focused Ultrasound Foundation action with less direct effects on reclassification: creating grants for regulatory science, educating stakeholders about FDA, and increasing direct-to-FDA advocacy. In this paper, each of these options and alternatives is assessed based on its likelihood of achieving success, time to success, and cost. Ultimately, this analysis recommends that the Focused Ultrasound Foundation take no statutory action to reclassify FUS at this time, and initiate efforts to increase Foundation stakeholder understanding of FDA regulations and their impact on the future of FUS.

Author information

Correspondence to Liz Dobrenz.

Rights and permissions

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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Keywords

  • Development Process
  • Significant Time
  • Focus Ultrasound
  • Regulatory Standard
  • Regulatory Science