Developers turn to FDA for next-gen app approval
There's already a bevy of medical-related apps on the market, helping patients manage weight and drug regimens. But the next generation of mobile medicine veers into medical device territory, meaning apps will need FDA OK before hitting the marketplace.
For some mobile developers, the costly and protracted process of getting FDA clearance is worth it, The New York Times reports. MobiSante, which markets a smartphone-based ultrasound system, willfully went through the FDA after considering selling its product solely overseas. The investment benefits of clearing the toughest regulatory agency in the world outweigh the attendant costs, co-founder Sailesh Chutani told the Times, and the company got FDA approval last year.
And MobiSante is hardly alone. App makers have expanded their ambitions from simple programs to those that take the role of medical devices. For instance, WellDoc markets an FDA-cleared diabetes management app that collects health data, and Akili Interactive is developing a video game to treat ADHD.
The developers foresee a future in which doctors will prescribe FDA-approved apps to treat patients, and Happtique, a subsidiary of the Greater New York Hospital Association, created a system that allows doctors to vet therapeutic apps and prescribe them to patients, the Times reports. Launching this week, Happtique evaluates available apps and, after prescription, can track whether a patients have download their apps and remind those who haven't.
All of this comes in a relative vacuum of input from the FDA. Thus far, the agency has maintained that it will only vet apps that perform device-like functions, such as making diagnostic determinations or treating ailments. The FDA has yet to release its full guidance on the regulation of mobile apps and will not go after the many available downloads that make untested medicinal claims until its rules are in place, an agency policy analyst told the Times.
- read the Times story
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