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Research Paper

Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience—Part 2: Medical Device Ecosystem and Policy

[+] Author and Article Information
Jan B. Pietzsch

Wing Tech Inc.,
42808 Christy Street, Suite 230,
Fremont, CA 94538;
Stanford University Program in Biodesign,
James H. Clark Center,
Stanford University,
318 Campus Drive, E-100,
Stanford, CA 94305-5428
e-mail: jpietzsch@wing-tech.com

Marta G. Zanchi

Medinnovo LLC,
333 West Santa Clara Street,
San Jose, CA 95113;
Wing Tech Inc.,
42808 Christy Street, Suite 230,
Fremont, CA 94538
e-mail: mgzanchi@medinnovo.com

John H. Linehan

Department of Biomedical Engineering,
Robert R. McCormick School of Engineering and Applied Science,
Northwestern University,
2145 Sheridan Road,
Evanston, IL 60208;
Stanford University Program in Biodesign,
James H. Clark Center,
Stanford University,
318 Campus Drive, E-100,
Stanford, CA 94305-5428
e-mail: linehan@northwestern.edu

Manuscript received May 23, 2012; final manuscript received November 21, 2012; published online June 24, 2013. Editor: Gerald E. Miller.

J. Med. Devices 7(2), 021003 (Jun 24, 2013) (5 pages) Paper No: MED-12-1074; doi: 10.1115/1.4023131 History: Received May 23, 2012; Revised November 21, 2012

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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