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U.S. Department of Health and Human Services

About FDA

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Research Project: Educational Outreach

Given the sheer numbers of medical devices that incorporate electronics and software and the complexity of these devices, there is no practical way to ensure their safety and effectiveness through a program of retrospective reviews and inspections. Safety and effectiveness must be designed in by the manufacturer. Established manufacturers generally do a good job of this, but some manufacturers lack the requisite technical expertise, resulting in unsafe or ineffective medical devices.

The Division of Electronics and Software Engineering has long devoted substantial resources to reducing this knowledge deficit. We administer or contribute to a variety of CDRH Staff College courses in the principles of medical instrumentation, software review practices, electromagnetic compatibility, design controls, and risk management We develop formal FDA guidances to industry on many of these topics, make presentations at trade conferences, publish articles and papers, and serve as faculty in courses offered to industry by trade associations such as AAMI and AdvaMed. Our staff sits on advisory boards at Rochester Institute of Technology and Drexel University. We have developed an introductory course on Medical Device Product Development at Drexel University that is in its third year. We have begun to expand the Drexel course into a certificate and Master’s degree program in Medical Device Product Development. We have engaged leading University experts in reliability (see white paper) to explore how to apply state of the art techniques to assuring the safety and effectiveness of medical devices.

Over the long term, we believe that the principles and practices of product realization need to be better integrated into the core engineering curriculum at both the undergraduate and graduate levels. We have had some promising conversations about this with a number of educators and this is an initiative that bears further investment.