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FDA Takes Hands-Off Approach to More mHealth Technologies

By Jennifer Bresnick

The FDA wants mHealth technologies that promote patient engagement to flourish without undue regulation that might stifle adoption and innovation, say FDA representatives in a new blog post. The FDA has released finalized guidance stating that it does not intend to regulate medical device data systems (MDDS) that store, display, or convert information produced by a different device.

“From wearable sensors to simple tracking apps, more and more consumers are choosing to use technology to monitor their health and motivate them to engage in health-promoting activities,” write Baku Patel, Associate Director for Digital Health at the FDA’s Center for Devices and Radiological Health and Jeffrey Shuren, MD, JD, Director of the FDA’s Center for Devices and Radiological Health.

“These products, which may count steps, calculate burned calories, or record heart rates and sleep cycles, all have the goal of helping individuals to live a healthy lifestyle.”

“The FDA seeks to advance public health by promoting innovation and development in this area by continually adapting our regulatory approach to technological advances to meet the needs of patients and consumers,” they added. “The MDDS guidance confirms our intention to not enforce compliance with applicable regulations for technologies that receive, transmit, store, or display data from medical devices. We hope that finalization of this policy will create an impetus for the development of new technologies to better use and display this data.”

In addition to stepping back from MDDS regulation, the FDA has recently announced its intention not to regulate low-risk wearable devices, such as fitness trackers or sleep monitors, and the apps that enable patients to keep tabs on their daily wellbeing. These “general wellness” tools are generally available from commercial retailers and present a very small risk to patient safety. At the same time, the FDA released guidance about the definition of a “medical device accessory.”

“FDA considers an ‘accessory’ as a medical device that is intended to support, supplement, and/or augment the performance of one or more medical devices,” the guidance said. “In practice, the distinctions among devices that support, supplement, and/or augment parent devices are subtle and many devices that we would consider to be an accessory may do more than one of these things.”

All three documents should soothe the mHealth developer industry, which spent several anxious years waiting for the FDA to take a stance on mobile health innovation. After releasing its major mHealth guidance in 2013, the agency has charted a relatively liberal path through the booming market of products aimed towards the “quantified self.”

“Through such smart regulation we can better facilitate innovation and at the same time protect patients,” Patel and Shuren said. The FDA will discuss the regulation in further detail during an upcoming webinar on February 24.




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