Assessing the Safety and Effectiveness of Devices after FDA Approval
Pew research on U.S. Food and Drug Administration postmarket surveillance studies appeared in the October issue of The Journal of the American Medical Association Internal Medicine. Postmarket surveillance—monitoring the safety and effectiveness of products once they are on the market—allows FDA to more quickly identify problems and accurately measure device performance and clinical outcomes.
The research found that study protocols frequently were not finalized at the time of approval, which contributes to delays in initiating and completing these studies. Additionally, small sample sizes and lack of availability of findings limit the clinical usefulness of the studies.
One way to address some of the limitations identified by the authors—including Rita Redberg, a cardiologist at the University of California, San Francisco—is through the wider use of medical device registries, which can quickly and efficiently collect data on large numbers of patients.
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Authors: Ian Reynolds, MPH; Josh Rising, MD, MPH; Allan Coukell, BScPharm; Kirsten Paulson, MS; Rita F. Redberg, MD, MSc