FDA Commissioner Scott Gottlieb discloses plan for digital medical device regulation

FDA Commissioner Scott Gottlieb announced a digital health innovation plan that will include a new post-market approach to how the agency regulates digital medical devices. He remarked that for such "technologies to take hold and reach their fullest potential, it is critical that the FDA be forward-leaning in making sure that we have implemented the right policies and regulatory tools…to encourage safe and effective innovation."

Gottlieb, who was confirmed last month to head the FDA, said the agency is working to implement the digital health provisions set out in the 21st Century Cures Act, which among other things makes clear that certain digital health technologies, such as mobile medical apps focused only on encouraging a healthy lifestyle, tend to be outside the FDA's purview. He noted that in the coming months the agency will publish guidance to further clarify what falls outside the scope of FDA regulation. "Greater certainty regarding what types of digital health technology is subject to regulation and regarding the FDA's compliance policies will not only help foster innovation, but also will help the agency to devote more resources to higher risk priorities," he said. 

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Further, the FDA is considering creating a third-party certification programme under which "lower risk digital health products could be marketed without FDA premarket review and higher risk products could be marketed with a streamlined FDA premarket review," Gottlieb said. He suggested that a unique pre-certification programme for software as a medical device could cut the time and cost of market entry for digital health technologies.

Gottlieb also suggested that post-market, real-world data collection, such as through the National Evaluation System for health Technology (NEST), could potentially speed up market entry and subsequent expansion of indications more efficiently. NEST, which is not owned or operated by the FDA, "will be a federated virtual system for evidence generation composed of strategic alliances among data sources including registries, electronic health records, payer claims and other sources," Gottlieb said, adding that a fully operational NEST system is expected by the end of 2019.

The FDA cited one report indicating there were an estimated 165 000 health-related apps available for Apple or Android smartphones last year, and that such apps will have been downloaded 1.7 billion times by 2017. 

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