Wednesday, July 20, 2011

The FDA Thinks Your Smartphone May Be A Medical Device

The Food and Drug Administration (FDA) has delivered on its promise to issue guidelines this year regarding “medical apps” that are being developed and issued daily across the United States. A press release regarding the Draft Guidance for Industry and Food and Drug Administration Staff—Mobile Medical Applications was posted yesterday and the proposed regulations can be found in their entirety here.

The draft has been issued to encourage feedback from manufacturers, health care providers, and others on how the FDA’s proposal may support the balance between promoting innovation and assuring safety and effectiveness. A good summary of the draft can be found here. The FDA is seeking public input on this approach. Once posted, comments can be submitted for 90 days online or in writing to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The FDA has focused on three primary segments of how to distinguish regulated “apps” and “manufacturers”—(i) mobile platform, (ii) mobile app, and (iii) mobile medical application. According to this summary, a mobile platform is a commercial off-the-shelf computing platform “with or without wireless connectivity” that is handheld. Mobile apps are software that can be run on a mobile platform or a Web-based software application that is designed for the mobile platform. Finally, a mobile medical app is one that meets the definition of “device” according to the FD&C Act, but also must be “used as an accessory to a regulated medical device” or “transform a mobile platform into a regulated medical device.”

Here are some examples of regulated mobile medical apps:

  • Apps that use a mobile platform to upload electroencephalograph (EEG) recordings and automatically detect seizures

  • Apps that use the built-in accelerometer or other similar sensors in a mobile platform to monitor the user's movement (useful in connection with measuring heart rates and detecting sleep phases, sleep apnea, falls, or other motions related to other conditions or diseases)

On the other hand, the FDA does NOT consider mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness to be mobile medical apps for purposes of these regulations. Examples of such apps include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness.

For nothing short of real entertainment, frequent the FDA Web site for the public comments over the next 90 days.

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