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

Jan B. Pietzsch*, Marta G. Zanchi, John H. Linehan

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

7 Scopus citations


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.

Original languageEnglish (US)
Article number021015
JournalJournal of Medical Devices, Transactions of the ASME
Issue number2
StatePublished - May 24 2012

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Biomedical Engineering


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