There’s an App for That – FDA to Regulate Mobile Health Apps

The U.S. Food and Drug Administration (FDA) is the agency that regulates mobile medical applications. FDA has jurisdiction over mobile medical apps because they fall into the category of medical “devices” which FDA clearly has jurisdiction over according to the Food, Drug and Cosmetic Act of 1938. “Devices” is defined as any product intended to diagnose, cure, mitigate, treat, or prevent disease, or any product intended to affect the structure or function of the body. This broad definition inevitably includes medical apps.

Mobile health apps have increased in popularity in recent years to include apps as simple as calorie trackers and diet and work out plan apps to apps more closely designed for treatment purposes like glucose monitoring and those that display medical images for physicians, radiologists, and technicians.  As another example, Smartphones are commonly used in place of stethoscopes and pagers by physicians. It is estimated that the number of consumers downloading mobile health applications doubles every year, and this number is expected to hit 500 million downloads by 2015. Additionally, the App Store, for Apple users, includes around 13,000 different health applications for its consumers.

With the market being flooded with these mobile health apps, especially those with mitigation of disease or treatment focuses, someone needs to be looking over developers’ shoulders ensuring that the technology is well-tested and reliable. FDA recently stepped up to the plate by announcing its Draft Guidance on Mobile Medical Applications (released July 2011). (Note: FDA Guidance documents are not legally binding but do reflect the current thinking of FDA officials who hold authorizing power over medical device applications.) FDA allowed time for public comments during the months following its release, and many groups, including app makers, have joined the conversation.

FDA also announced its intention to finalize the Draft Guidance by the end on 2013. However, some lawmakers and advocacy groups are pressuring the FDA to hold off for now. These groups suggest that FDA needs to clarify its regulatory policies regarding mobile health. Others suggest that FDA needs more time and resources to adequately plan for the extra work it will soon take on as a result of the new regulations. Others have even suggested that a new division entirely be created and given authority over medical app approvals to ensure adequate scientific expertise for the testing and approval processes. At bottom, it’s clear that app makers, many of whom are IT folks with little experience in the medical industry, need guidance. FDA is the most favorable agency positioned to do that.


3 thoughts on “There’s an App for That – FDA to Regulate Mobile Health Apps

    • App makers need both guidance and oversight. One issue with FDA’s Guidance document is that it is nonbinding to begin with. This leaves the agency with little authority. Next, it’s unclear on how the FDA will classify certain apps, for approval purposes, which leaves app makers confused. FDA divides medical devices into three categories based on the risks they present: Class I (low risk), Class II (moderate risk), and Class III (high risk). Band-Aids are examples of a Class I device one. Class I devices do not require pre-market approval. Class II devices require pre-market approval but that approval is an expedited process. Class III devices appropriately require much more intense review.
      The problem is that app makers are not sure where FDA will draw the line when it comes to classifying their device. To be fair, FDA possibly isn’t sure about the lines either as this is a new area of oversight for them. Lastly, because technology changes so quickly, one device may change from a Class I device to a Class II or III with just a small change in technology. This means that even after apps are on the market, FDA must have the authority of oversight to periodically review these apps to be sure they are reliable and safe for consumers.

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