FDA to start reining in the Wild West of medical apps
The FDA says it is only regulating products that turn smartphones into medical devices it already oversees, such as apps that let your phone act as an electronic stethoscope or give feedback on CPR.
The Wild West of mobile medical apps is getting a little more tame two years after the US Food and Drug Administration first proposed regulating any mobile app deemed a medical device.
The administration announced Monday that it is issuing final rules governing the development and oversight of health-related apps, with a particular (and obvious) focus on those that could be harmful if defective or misused.
To be clear, the FDA says it is only regulating products that turn smartphones into devices it already oversees (think electrocardiograms or ECGs) or serve as an accessory to a device that is already regulated.
It will not, however, regulate the sale or general use of smartphones, tablets, or mobile app distributors (think iTunes or Google Play stores), or the personal use of basic wellness apps like medical dictionaries and tutorials, heart rate monitors, or pedometers.
"It's not about the platform," Dr. Jeffrey Shuren, who directs the FDA's medical device division, told reporters on a conference call. "It's about the functionality. An ECG is an ECG."
The FDA said it has already cleared roughly 100 mobile medical apps in the past 10 years, with 40 of them being cleared in the past two years. Shuren said it takes an average of just over two months (67 days) to review a medical app.
One report published by research2guidance in March found that there are already 97,000 mobile health apps in the major app stores, and that the market for these apps should hit $26 billion by 2017. The FDA did not outline how many of those will come under the new review system, and did not say whether the administration would retroactively review and regulate any of the existing apps.
Check out the FDA's full guidance report here.