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FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012
Study Questions:
What are the prevalence and characteristics of changes to cardiac implantable electronic devices (CIEDs) made through the premarket approval (PMA) supplement process from 1979 to 2012?
Methods:
Using the Food and Drug Administration’s (FDA’s) PMA database, authors reviewed all CIEDs approved as original PMAs or supplements from 1979-2012. For each supplement, the FDA collected the date approved, type of supplement (panel-track, 180-day, real-time, special, and 30-day notice), and the nature of the changes. They calculated the number of supplements approved per PMA and analyzed trends relating to different supplement regulatory categories over time. For supplements approved via the 180-day regulatory pathway, which often involve significant design changes, from 2010-2012, authors identified how often additional clinical data were collected.
Results:
From 1979-2012, the FDA approved 77 original and 5,829 supplement PMA applications for CIEDs, with a median of 50 supplements per original PMA (interquartile range [IQR], 23-87). Excluding manufacturing changes that do not alter device design, the number of supplements approved each year was stable around a mean (standard deviation) of 2.6 (0.9) supplements per PMA per year. Premarket approvals remained active via successive supplements over a median period of 15 years (IQR, 8-20), and 79% of the 77 original PMAs approved during the study period were the subject of at least one supplement in 2012. Thirty-seven percent of approved supplements involved a change to the device’s design. Among 180-day supplements approved from 2010-2012, 23% (15/64) included new clinical data to support safety and effectiveness.
Conclusions:
Many CIED models currently used by clinicians were approved via the PMA supplement process, not as original PMAs. Most new device models are deemed safe and effective without requiring new clinical data, reinforcing the importance of rigorous post-approval surveillance of these devices.
Perspective:
Patients may benefit when new CIED technology is rapidly approved and adopted via supplement PMA. However, if the ratio of supplemental to original PMAs is 50 to 1, one has to infer that the CIEDs in use in the United States are potentially much different from the original devices approved through the mandated clinical testing of PMA. Medtronic’s Sprint Fidelis and St. Jude’s Riata leads, widespread in use prior to their recall, are examples of devices approved via supplement PMAs. While the authors do not explicitly question the wisdom of expedited device change approvals, they offer strong evidence in favor of rigorous post-approval surveillance. Patients and clinicians should be aware that clinical data are rarely collected as part of PMA supplement applications prior to marketing.
Keywords: United States Food and Drug Administration, Dietary Supplements, Device Approval, Marketing, Equipment Design
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