Integrated Devices: A New Regulatory Pathway to Promote Revolutionary Innovation.

UNITED States. Food & Drug Administration; EUROPEAN Union

Policy PointsCurrent 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 [ABSTRACT FROM AUTHOR]

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