Abstract 17021: Association Between Regulatory Review Times and Adverse Event Reports in New Cardiovascular Devices
Introduction: The Food and Drug Administration (FDA) approves new high-risk medical devices after reviews of safety and effectiveness data gathered in clinical trials. Some have advocated for shorter review times to encourage innovation. We evaluated whether regulatory review time and product novelty predict adverse events involving high-risk cardiovascular devices.
Methods: All high-risk cardiovascular devices approved between 2000-2009, grouped by FDA-assigned product codes were linked to regulatory review data and adverse events reported in the FDA’s Manufacturer and User Facility Device Experience database over the four years following FDA approval. Adverse events were classified according to severity, and linear probability / logistic regression models evaluated whether regulatory review times or product novelty predicted adverse event reporting.
Results: Regulatory review times for 106 devices averaged 14.6 (SD: 9.77) months. Only 48/106 (45%) of devices in 28 product codes had at least 1 reported adverse event (mean: 182, range: 1-2706), yielding a total of 8,721 adverse event reports. Shorter regulatory review times were associated with a higher probability of any adverse event, as well as a higher probability of patient injury/death: a one standard deviation decrease in regulatory review time was associated with a 13.7% absolute/30.4% relative increase in risk of any adverse event reporting (95% CI: 6.8-20.5, p<0.001), a 9.8% absolute/39.1% relative increase in absolute risk of adverse events involving serious injury or death (95% CI: 2.0-17.6, p=0.02), and a 9.8% absolute/39.1% relative increase in probability of being in the top quartile of the count of total adverse events involving injury or death (95% CI: 2.0-18.6, p=0.02). Controlling for review time, novelty of a product was not predictive of the presence or frequency of adverse event reports.
Conclusion: High-risk cardiovascular devices with shorter FDA reviews were associated with a higher probability of any reported adverse events, of events involving serious injury or death, and were more likely to be among those with the highest number of adverse event reports of injury or death. These data should inform current proposals aimed at expediting the review of high-risk devices.
Author Disclosures: A.D. Stern: None. D.B. Kramer: None. M.D. Ouellet: None. A.S. Kesselheim: None.
- © 2015 by American Heart Association, Inc.