Medical device regulation plays a significant role in promoting and protecting the public health. But the regulatory process and its requirements also exercise substantial influence over the design, development, and commercialization of new medical technologies. In recent months, FDA’s premarket notification (510(k)) process, through which the majority of medical devices are cleared to the market, has been at the forefront of policy discussions, and efforts are continuing to further analyze and strengthen the process. In this paper, we report findings from our recently completed, comprehensive, industry-wide survey to provide input and perspective for the current discussions about changes to the 510(k) process. The findings reported here focus on five aspects of the 510(k) process with principal relevance to medical technology developers and innovators: predictability of the process, impact of regulatory requirements, role of guidance documents, interaction with FDA, and international comparisons. The results confirm the substantial influence of regulatory requirements on investment decisions and development priorities. The data suggest that improvement of regulatory process predictability needs to be a top priority for all stakeholders – especially FDA. Increasing the number of guidance documents available to industry, and ensuring that their content is timely updated to reflect current FDA thinking, could be one way to achieve this goal. Consistent implementation of the regulatory process and enhanced communications between sponsors and the agency could further contribute to improvements, along with efforts to provide additional training opportunities for reviewers and industry personnel. The survey data suggest that small companies, when compared to large companies, are particularly challenged by the current process, and should therefore receive particular attention in any reform and improvement efforts.
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June 2012
Research Papers
Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience
Jan B. Pietzsch,
Jan B. Pietzsch
Wing Tech Inc.
, 42808 Christy Street, Suite 230, Fremont, CA, 94538jpietzsch@wing-tech.comStanford University Program in Biodesign,
James H. Clark Center
, 318 Campus Drive, E-100, Stanford, CA, 94305-5428
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Marta G. Zanchi,
Marta G. Zanchi
Medinnovo, LLC., 333 West Santa Clara Street, San Jose, CA, 95113;
e-mail: mgzanchi@medinnovo.com
Wing Tech Inc.
, 42808 Christy Street, Suite 230, Fremont, CA, 94538
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John H. Linehan
John H. Linehan
Northwestern University, Department of Biomedical Engineering,
Robert R. McCormick School of Engineering and Applied Science
, 2145 Sheridan Road, Evanston, IL, 60208linehan@northwestern.eduStanford University Program in Biodesign,
James H. Clark Center
, 318 Campus Drive, E-100, Stanford, CA, 94305-5428
Search for other works by this author on:
Jan B. Pietzsch
Wing Tech Inc.
, 42808 Christy Street, Suite 230, Fremont, CA, 94538jpietzsch@wing-tech.comStanford University Program in Biodesign,
James H. Clark Center
, 318 Campus Drive, E-100, Stanford, CA, 94305-5428
Marta G. Zanchi
Medinnovo, LLC., 333 West Santa Clara Street, San Jose, CA, 95113;
Wing Tech Inc.
, 42808 Christy Street, Suite 230, Fremont, CA, 94538e-mail: mgzanchi@medinnovo.com
John H. Linehan
Northwestern University, Department of Biomedical Engineering,
Robert R. McCormick School of Engineering and Applied Science
, 2145 Sheridan Road, Evanston, IL, 60208linehan@northwestern.eduStanford University Program in Biodesign,
James H. Clark Center
, 318 Campus Drive, E-100, Stanford, CA, 94305-5428J. Med. Devices. Jun 2012, 6(2): 021015 (8 pages)
Published Online: May 24, 2012
Article history
Received:
January 31, 2012
Revised:
March 17, 2012
Online:
May 24, 2012
Published:
May 24, 2012
Citation
Pietzsch, J. B., Zanchi, M. G., and Linehan, J. H. (May 24, 2012). "Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience." ASME. J. Med. Devices. June 2012; 6(2): 021015. https://doi.org/10.1115/1.4006781
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