Research Papers

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

[+] Author and Article Information
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, 94305-5428jpietzsch@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, 94538mgzanchi@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, 94305-5428linehan@northwestern.edu

The Safe Medical Devices Act of 1990 added “special controls” to the mechanisms by which FDA could establish reasonable assurance of the safety and effectiveness. These controls can include the promulgation of performance standards as well as postmarket surveillance, patient registries, development and dissemination of guidance documents, and other appropriate actions as FDA deems necessary.

As a point of comparison, the investigators also performed statistical analyses for a subset of survey responses that averaged 148 days total review time. For almost all survey questions, the results did not differ by more than 2–3% from the results for all respondents, who experienced a 211-day total average review time.

J. Med. Devices 6(2), 021015 (May 24, 2012) (8 pages) doi:10.1115/1.4006781 History: Received January 31, 2012; Revised March 17, 2012; Published May 24, 2012; Online May 24, 2012

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.

Copyright © 2012 by American Society of Mechanical Engineers
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Figure 1

Importance of regulatory requirements for business decision about major investment in a new product

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Figure 2

Importance of predictability of the regulatory process in deciding about first country for market launch

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Figure 3

Role of device-specific guidance documents: percentage of not substantially equivalent or withdrawn submissions with and without existing guidance documents (left), versus the percentage of substantially equivalent submissions with and without existing guidance documents (right)

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Figure 4

Breakdown of FDA requests for additional information, as reported by respondents

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Figure 5

Respondents’ interpretation of the nature of FDA questions or requests for information received during a 510(k) review



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