During 2007 and 2008, the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) developed a 10-year forecast for medical device technologies. It updates and expands the 10-year technology forecast that CDRH's Office of Science and Engineering Laboratories performed in 1997-1998.

The primary purpose of the forecast is to help CDRH (and other medical device stakeholders) prepare for pioneering products that will pose new scientific questions and regulatory issues during the next decade. This preview it provides is intended to help CDRH develop initiatives to identify key scientific issues, collect basic information, and set clear regulatory strategies for responding to a flow of new products.

To these ends, the forecast identifies emerging medical device technologies and types of devices that manufacturers are highly likely to submit to CDRH for pre-market decision making. It casts an intentionally broad net: there's no implication that any particular development identified here will necessarily be subject to FDA regulation.

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*At the time of the study, William A. Herman was Deputy Director of the Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, FDA. Gilbert B. Devey was a Program Director in the National Science Foundation's Directorate of Engineering.