Integrated Devices: A New Regulatory Pathway to Promote Revolutionary Innovation
Published Web Location
https://onlinelibrary.wiley.com/doi/10.1111/1468-0009.12692Abstract
Policy Points Current medical device regulatory frameworks date back half a century and are ill suited for the next generation of medical devices that involve a significant software component. Existing Food and Drug Administration efforts are insufficient because of a lack of statutory authority, whereas international examples offer lessons for improving and harmonizing domestic medical device regulatory policy. A voluntary alternative pathway built upon two-stage review with individual component review followed by holistic review for integrated devices would provide regulators with new tools to address a changing medical device marketplace.
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