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Background: The FDA increasingly relies on medical device registries to help promote effective safety surveillance of high-risk medical devices in the US. However, there are limited uniform standards for how device registries should be organized or the data collected. Therefore, there may be substantial variability in registry implementation, which can reduce their utility to regulators. Objective: To survey the current landscape of US cardiovascular device registries and chart the extent of inconsistency in research goals, administration, enrollment procedures, and approach to data access. Methods: A systematic review using PRISMA guidelines was conducted to identify studies (1995-2017) referencing cardiovascular device registries with a US-based institution. Registries referenced in these studies were evaluated by reviewing associated manuscripts and websites. Data extracted for each registry included device type, primary scientific aim(s), funding, stewardship (e.g., administration of registry procedures), enrollment procedures, informed consent process, and mechanisms to access data for research. Results: The 138 cardiovascular device registries in the cohort ( TABLE ) covered devices addressing interventional cardiology (65.9%, 91/138), arrhythmias (15.2%, 21/138), heart failure (10.1%, 14/138), and valvular disease (10.1%, 14/138). While the majority (55.8%, 77/138) were industry-funded, stewardship was predominantly overseen by academic centers (74.0%, 102/138). Most registry participation was voluntary (77.5%, 107/138), but a substantial minority (20.3%, 28/138) were required as a condition of device implantation. Informed consent requirements varied widely, with written consent required in only 55.1% of registries. Registry data were primary accessible only to stewards (84.1%, 116/138), with 13.8% (19/138) providing pathways for external applications. Conclusion: The majority of cardiovascular device registries over the past two decades were funded privately under the auspices of academic institutions, which set the rules for data access. The substantial variation between cardiovascular device registries indicates a role for regulators to strengthen guidelines to improve quality, consistency, and ethical standards.

A recent Food and Drug Administration (FDA) proposal aims to speed the evaluation process for new high-risk medical devices that are intended to address unmet medical needs,1 much like existing expedited approval processes, such as the humanitarian device exemption rule for devices intended to treat rare diseases. Such programs are strongly supported by the medical device industry and some patient advocacy groups, which have criticized the FDA for being too stringent in its evidentiary requirements for investigational devices, leading to delays in the approval of potentially helpful products.2–4 For example, in 2011, the FDA approved a transcatheter aortic valve replacement system that demonstrated significant improvements over conventional treatment options for selected patients with severe aortic stenosis.5,6 However, the United States was the 43rd country to approve the device, roughly 4 years after the European Union.7 Yet expedited approval for high-risk medical devices raises the possibility that these devices will not be as effective as predicted in their limited premarket testing or that they could cause unanticipated harms after approval.8 Of course, well-studied devices may present unexpected safety concerns years after approval,9,10 and even the most rigorous conventional premarket approval process will result in some devices later found to be unsafe or ineffective.11–13 Safety of approved medical devices and the proper scope of premarket testing remain contentious issues after recalls of several widely used devices, including popular models of implantable cardioverter defibrillator leads14,15 and metal-on-metal hip implants.16 Inherent limitations in premarket testing, along with the prospect of lowered evidentiary standards for expedited device reviews, place greater pressures on postapproval monitoring of devices to follow clinical performance and to identify emerging public health problems. Medical device manufacturers routinely perform this sort of vigilance, …