Miscategorization of Deaths in the US Food and Drug Administration Adverse Events Database

JAMA Intern Med. 2019 Oct 7. [Epub ahead of print]

As the US Food and Drug Administration (FDA) moves to hasten approval of medical devices, data from postmarketing studies and registries are increasingly relied on to inform decision-making.

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As the US Food and Drug Administration (FDA) moves to hasten approval of medical devices, data from postmarketing studies and registries are increasingly relied on to inform decision-making. With less time for premarketing clinical studies, postmarketing data are the principal way adverse events and risks become apparent. Even for high-risk implanted devices, premarketing trials are usually small and have short-term follow-up. The process of reporting adverse events is cumbersome, and reporting rates are low.