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Some experts have expressed concerns about the lack of evidence required for FDA approval of medical devices, including cardiovascular devices. Prior to the 21st Century Cures Act of 2016 — which emphasized the need for better postapproval studies, even as it suggested that initial approval might proceed even faster — 65% of FDA premarket approvals for high-risk cardiovascular devices were based on single studies and less than a year of median follow-up (NEJM JW Cardiol Feb 2010 and JAMA 2009; 302:2679). Fewer than a third of the studies had randomized trial evidence. Moreover, although many devices were subject to FDA-mandated postapproval studies, about half of these were not completed even a decade later — and those that were completed, …