The significance of the guidelines reflects the rapidly developing healthcare delivery technologies and the need for efficiency and a “longer reach” for health care. It also effects any software developed for a technology if it is used in the United States. Therefore, if you are developing a device that utilizes a mobile application in Norway that may be used in the United States, take notice. 

 

While we typically think of how implantable devices, diagnostic devices and devices used in procedures have either embedded or remote communication software, mobile technology reaches much further than existing technology. Examples of the “longer reach” are technologies that empower individuals to monitor their health during normal work and life activities, providing mobile health monitoring to the elderly, those who live in rural or remote areas, or even in times of inclement weather is being advanced by mobile technologies. Consider that even now, remote technologies can be used to diagnose and monitor medical conditions in under developed and developing countries.

 

The draft guidelines have 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 at mobihealthnews.com. 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:

 

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 some interesting comments on the proposed guidelines and some insight on how it will impact mobile devices, applications and software utilized in the U.S. market, view the FDA Web site for the public comments during the upcoming days.