FDA Signals Move to Regulate Medical Apps

FDA Signals Move to Regulate Medical Apps

The Federal Drug Administration is making moves to regulate the growing number of mobile medical apps later this year, which could impact a growing market.

The FDA’s Center for Devices and Radiological Health plans to issue guidelines on mobile medical applications later this year, concerned with issues of efficacy and safety as the development and usage of mobile medical apps gains momentum. The regulation could impact a growing market estimated to be worth $2 billion.

The devil will be in the details and exactly how the rules are spelled out could have big implications. As it stands today, if the device transmits data but doesn’t control or alter the function of a medical device, it may be defined as a medical Device Data System by the FDA, a classification that is exempt from the stricter rules that are reserved for devices used in patient monitoring.

Some app makers have already gone through the approval process with the FDA, which could indicate how and to what extent the federal agency will regulate apps.

The first app developer to secure FDA clearance was AirStrip Technologies, whose app allows physicians to monitor a mother and baby remotely during delivery, something considered to be a true clinical tool since it allows the physician to make clinical decisions and will be sold only to hospitals and used with existing monitoring systems.

FDA clearance allowed the company to market its app as a clinical tool, and not just a simple mobile app, according to AirStrip.

The FDA in February also cleared MobiUS, an app developed by Mobisante, which allows viewing of medical images for diagnostic purposes. Mobile MIM, a remote diagnostic imaging tool created by MIM Software, was also approved the same month.

There are apps to detect malaria, diagnose skin diseases and mobile accessories to analyze tissue for certain types of cancer, and with doctors in the Mayo clinic using apps like Pocket Lab Values to double-check lab results, it is evident that medical apps cover a wide array of uses, and are here to stay.

The prevalence of medical apps raises questions about when a smartphone becomes a medical device, and subject to FDA regulations. After all, an app that lists symptoms of a disease isn’t in the same category as one that can be used to monitor a fetal heartbeat during delivery.

The balancing act before the FDA will be to encourage app development and not stifle an emerging industry, but also regulate those innovations to ensure they meet high quality standards and are safe and effective for the patients.

To date, the FDA hasn’t been involved in regulation of the clinical app development, but the fact that it’s drafting a preliminary exploration on the subject and plans to submit it to the medical community for review indicates the agency will be more proactive in monitoring these products in the future.

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