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

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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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11176405PMC
http://dx.doi.org/10.1111/1468-0009.12692DOI Listing

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