Changes to Heart Devices May Have Occurred Without Proper FDA Review

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A new report suggests that many models of high-risk devices, such as cardiac implantable electronic devices, were approved through a process that does not require a review of new clinical data.

A report in the Jan. 22/29, 2014, issue of the Journal of the American Medical Association suggests that many models of high-risk devices, such as cardiac implantable electronic devices (CIEDs) currently used by clinicians, were approved through a premarket approval (PMA) supplement process, not as original PMAs. The supplemental PMA process does not necessarily require new clinical data to be reviewed.

Researchers said that from 1979 through 2012 the Food and Drug Administration approved just 77 PMA applications that required manufacturers to provide clinical data on safety and effectiveness, but during the same period the original PMAs were associated with over 5,800 PMA supplement applications without the need for clinical data. While this covers minor changes such as labeling and packaging changes, it also includes changes to device design. Among 180-day supplements approved from 2010 to 2012, 23% included new clinical data to support safety and effectiveness.

Researchers concluded that the study reinforces the importance of rigorous post-approval surveillance of these devices.