Silver Spring, June 2017. FDA Commissioner Scott Gottlieb launched some digital health fireworks recently when he announced the FDA is developing a pilot program allowing lower risk mobile medical apps to be marketed via third-party certifications, sounding vastly similar to the current European approach (CE Marking). Gottlieb indicated third-party certification is also being considered to streamline premarket reviews of higher risk digital health products including software as a medical device (SaMD), and will be piloted later this year. Developers who “consistently and reliably engage in high quality software design and testing (validation) and ongoing maintenance of its software products” and have low risk device use indications may be eligible, and “could reduce the time and cost of market entry for digital health technologies.” Related to this announcement, FDA is working on a SaMD guidance and a dedicated unit to support digital health FDA activities.
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