As a general matter FDA regulates all medical devices and FCC regulates devices that utilize electromagnetic spectrum - i.e. broadcast devices. So with regard to mobile health devices - sensors, applications, systems - FDA regulates any given device as a medical device while FCC regulates the device as a communications device.
Recognizing the potentially overlapping jurisdiction in digital health, in 2010 the agencies entered into a Memorandum of Understanding "to promote collaboration and ultimately to improve the efficiency of the regulatory processes applicable to broadband and wireless enabled medical devices."
Last month FCC announced its mobile body area network ("MBAN") proposal, which would allocate electromagnetic spectrum for personal medical devices. The allocated spectrum would be used to form a personal wireless network, within which data from numerous body sensors could be aggregated and transmitted in real time.
Meanwhile, the regulatory picture with regard to FDA is in flux. The agency issued draft guidance on mobile medical applications in July of 2011. But, two weeks ago U.S. Senators made a last-minute amendment to the Prescription Drug User Fee Act (PDUFA) reauthorization bill. The senate added language which would prevent the FDA from final rulemaking with regard to mobile medical apps until the Department of Health and Human Services could provide recommendations. Those recommendations would be pursuant to an expert panel on medical device and health-IT regulation. The House version of PDUFA reauthorization does not contain a similar amendment. Some industry watchers suggest the amendment may be dropped when the House and Senate versions of the bill are reconciled.
The uncertain regulatory environment spurs many interesting questions. For example, with regard to wearable sensors - which may provide data on heart rate, pulse, blood pressure, and so forth - can marketing proceed based on FCC approval alone? What if such devices were marketed purely as personal information devices, rather than medical devices, would FDA approval not be required? There are many sensors and related smartphone apps on the market already.
And what if the wearable devices are implanted? This may seem futuristic but in fact it may not be far off. A near-term future of ubiquitous biosensors delivering critical data in real time is being promoted by the visionaries behind the X Prize, who recently teamed up with Nokia to create the Nokia Sensing X Challenge. Could an individual implant sensors into himself for personal monitoring, per the FCC allocated spectrum, but without regard to FDA? Not likely.
Given the potentially grey area between a medical device and a personal information/communication device in the mHealth space, these questions are still open for debate.