Califf, Shuren Want National Tech Evaluation System
Writing in a Journal of the American Medical Association column, FDA commissioner Robert Califf and CDRH director Jeffrey Shuren say that a “national evaluation system that engages all stakeholders could enable FDA to focus efforts on facilitating the development and interpretation of more informative data essential for policy-making and clinical decisions for individuals and populations.” When issues with medical technologies arise, they write, they could potentially be quickly detected and understood within the appropriate context. The changes ultimately could lead to a much more efficient system that rewards innovation that leads to better health outcomes, they say, creating powerful incentives for continuous improvement and accelerating access to technologies that patients and doctors can use with the assurance of safety, efficacy, and a well-characterized balance of benefit and risk.
The two agency executives write that a key dilemma for medical device regulation is how to ensure timely access while also providing evidence to guide safe and appropriate use. Although residual uncertainty about an approved device’s benefit and risk is typically addressed through post-market evaluation, they say, current approaches to such evaluation have limitations.
“Even though FDA can require device manufacturers to perform postmarket studies,” they say, “patients have few incentives to enroll in a study once a device is marketed, and many FDA-mandated postmarket studies for devices have been delayed, scaled back, or never finished.” They also note that reporting of adverse events and device malfunctions currently depends on clinicians identifying and reporting a possible association, making under-reporting a likely situation. “However,” Califf and Shuren write, “a strategic approach to linking and using clinically based data sources, such as registries, electronic health records, and claims data could potentially reduce the burdens of obtaining appropriate evidence across the life cycle of a device. By leveraging clinical data and applying advanced analytics and flexible regulatory approaches tailored to the unique data needs and innovation cycles of specific device types, a more comprehensive and accurate framework could be created for assessing the risks and benefits of devices.”
The article says that in 2012 FDA took the first steps toward establishing a National Evaluation System for Health Technology that could quickly identify problematic devices, accurately and transparently characterize and disseminate information about device performance in clinical practice, and efficiently generate data to support premarket clearance approval of new devices and new uses of currently marketed devices.