abstract

The FDA 510(k) clearance process is the most common regulatory pathway for medical devices. Since 2010, it has been at the forefront of regulatory policy discussion, with a multitude of stakeholders involved in a substantive exchange of ideas about the need and opportunities for improving the process and its implementation. This article is the second in a two-part series reporting the findings of a questionnaire-based assessment of recent industry experience with the 510(k) process. While the first article focused on findings directly relating to the medical device innovation process, this article reports more broadly on the findings and implications of interest to the medical community and policymakers. We discuss results in five key areas, ranging from the current performance of the 510(k) regulatory process to proposed changes and suggested performance metrics, and place identified challenges in perspective with ongoing and forthcoming FDA actions. Through the survey we also report on current trends in the amount of clinical evidence required by FDA for 510(k) devices and on the interactions between sponsors and the agency during various phases of clinical testing. The results suggest that significant opportunities exist for both industry and FDA to further improve the 510(k) process and the effectiveness of its implementation. Continued collection of process performance data can contribute to prioritizing suggested policy changes, and gauging their effects in a timely manner.

Copyright © 2013 by ASME
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