Integrated Devices : A New Regulatory Pathway to Promote Revolutionary Innovation

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 U.S. Food & Drug Administration efforts are insufficient due to a lack of statutory authority, while international examples offer lessons for improving and harmonizing domestic medical device regulatory policy. This working papers reviews a potential voluntary alternative pathway built up two-stage review with individual component review followed by holistic review for integrated devices that would provide regulators with new tools to address a changing medical device marketplace