This study evaluates the randomized clinical trials conducted to provide evidence of the safety and effectiveness of cardiovascular devices approved by the Food and Drug Administration (FDA). The FDA approves high-risk devices through premarket approval if it determines the device provides reasonable assurance of safety and effectiveness. The dual goals of this approval process are to ensure patient safety and facilitate access to beneficial technologies. For the past several decades, priority review mandated by legislation has intended to hasten FDA approval, whereby an application receives precedence in review and additional review resources, if needed. The 21st Century Cures Act of 2016 introduced the Breakthrough Devices program, an initiative that is built on but supersedes another program known as Priority Review. Under Breakthrough Devices, the FDA “may accept a greater degree of uncertainty of the benefit-risk profile for these devices if the uncertainty is sufficiently balanced by other factors […] and adequate postmarket controls to support premarket approval.”1 The quality of evidence required for cardiovascular devices to be approved under Priority Review is not known.
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Jones LC, Dhruva SS, Redberg RF. Assessment of Clinical Trial Evidence for High-Risk Cardiovascular Devices Approved Under the Food and Drug Administration Priority Review Program. JAMA Intern Med. 2018;178(10):1418–1420. doi:10.1001/jamainternmed.2018.3649
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