FDA’s device center chief Jeff Shuren, in an interview with Inside Health Policy, highlighted the benefit a robust National Device Evaluation System could have in bolstering the agency’s ability to monitor devices in real-time to better inform the risk-benefit profile of approved products. Such a system, he said, could also help in the premarket approval phase to reduce the clinical trial burden on manufacturers and get products to market faster.
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Shuren said the goal is to create a system that can pull from a number of data sources — including electronic health records and medical device registries — to develop more robust, real-world evidence on products already on the market. Such a system, he said, could more quickly alert the agency to safety concerns for devices in the marketplace, and also provide FDA a firmer understanding of the risk-benefit profile of approved devices.
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While the agency plans to rely on information gleaned in medical device registries, the goal is not to create a single, giant repository for information. “The National Evaluation System is much more about the strategic alliance between those data sources, a governance structure over that for rules of the road…and trying to promote the development of additional infrastructure,” Shuren said.
This year, FDA plans to identify an appropriate entity to serve as a national coordinating center for the National Evaluation System.
FDA’s postmarket surveillance system has come under heavy scrutiny in recent months. The ranking Democrat on the Senate health committee, Sen. Patty Murray (WA), released a scathing report last year on the agency’s postmarket oversight of duodenoscopes, taking issuing specifically with the need for manufacturers to essentially self-report adverse events.
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Sources point to a lack of funding as a main reason for FDA’s inability to effectively monitor medical devices in the postmarket setting. Some stakeholders pointed to the disparity in user fees between the drug and device centers as a main reason for the lack of available resources, but others defended the amount of money the device industry currently provides as reflective of the gap in market caps between large manufacturers and smaller device start-ups.
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“I think more money is problem number one and without more money the agency is never going to do a good job,” Diana Zuckerman, president of the National Center for Health Research, told IHP.
Stakeholders have suggested the medical device user fee process is more difficult to navigate than the sister program in the drug center, given the financial disparity in the medical device industry between the large corporations and smaller start-ups. Zuckerman, however, argued that no one is expecting a small device company to pay millions in user fees to cover something like postmarket surveillance.
“There are many small companies and, yes, small companies should have user fees that are affordable, but the medium, large and extra-large sized device companies could be paying a lot more,” she said.
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