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The Food and Drug Administration today issued its final guidance on the regulation of health apps and other software, and health tech developers should be breathing a sigh of relief.
The FDA confirmed that it’ll take a hands-off approach to most medical device data systems (MDDS), or software that conveys data to and from a medical device (like a glucose meter, for example).
“This guidance confirms our intention to not enforce regulations for technologies that receive, transmit, store, or display data from medical devices,” the FDA statement reads. “We hope that finalization of this policy will create an impetus for the development of new technologies to better use and display this data.”
The agency updated its Mobile Medical Apps guidance to be consistent with the MDDS final guidance. In general, the FDA will not regulate apps that don’t pose a real health threat to the user if they malfunction. And most of the apps that fit that bill are ones that turn a mobile device into a serious diagnostic or treatment platform. That is, they “transform a mobile platform into a regulated medical device by using attachments, display screens, sensors, or other such methods,” in the FDA’s words.
Other apps will be left alone, such as ones that just help users document or track basic health metrics, or self-manage a disease or condition without providing specific treatment advice.
“FDA is certainly sticking to its word, working to down-classify or altogether exempt low-risk software-based technologies,” said our go-to FDA regulation specialist, attorney Brad Thompson, who works with medical devices makers to navigate the sometimes tricky FDA regulatory waters.
Thompson said today’s news is big for the health tech industry. “The implications are profound, both for MDDS-type software, but also for what it suggests about the future for health information technology generally,” he said. “FDA is quite earnestly working to ensure that it uses the lightest regulatory touch appropriate for software.”
“It’s exciting, because it means that innovation in this space can truly flourish. This is a very natural extension from the recent FDA guidance on accessories where FDA acknowledges that the risk associated with an accessory is not necessarily the same as the risk of the parent medical device.”
The news comes just weeks after the FDA issued two draft guidances that explain how it intends to regulate low-risk hardware and software products focused on general wellness and medical device accessories. It’ll take a similar light regulatory approach to these product classes.
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