What exactly qualifies an app as a medical device? The healthcare industry has been waiting for a little more clarity on this issue ever since the FDA said it would regulate medical apps that can be used as an accessory to a medical device or transforms a mobile platform into a medical device. Well, the FDA has finally released its final guidance on medical mobile apps to offer a clearer definition of a medical device app and what they plan to do with those apps that fall into that gray space between just an app and a medical device.

The final draft guidance does not offer too many surprises from the original draft released in July 2011, but the addition of several appendices offer manufacturers examples of the types of apps that will and will not be regulated. Perhaps the section most relevant to marketers in this industry is: Appendix B: Examples of mobile apps for which FDA intends to exercise enforcement discretion. These are the apps that may qualify as medical devices, but pose a lower risk to the public so the FDA will not regulate them at this time.

Now that the industry has a better idea of how the FDA plans to approach apps, the question becomes whether this will change the industry’s approach to apps and how this guidance will ultimately help and/or limit the industry.

How The Guidance Will Help The Industry

John Avellanet, a Managing Director & Principal at Cerulean Associates LLC and an expert on FDA compliance issues, says that these guidelines will help current app developers in three ways:

1. The FDA’s “rules of the road” are now much clearer, so this should help developers understand where and how to draw the boundaries of what their apps can and cannot do if they want to avoid detailed scrutiny (and lengthy review processes).

2. This will also help developers and marketers promote usage of their medical apps by patients, physicians and other healthcare providers. The guidance and FDA’s webpage on medical apps can give users confidence that their medical app followed the rules—this is something that savvy marketers and developers can point out.

3. This can help speed up the development and adoption of mobile medical apps. If I know the rules of the road, and I know what I want to achieve with my app, I can now clearly figure out a way to get there without running afoul of the FDA or inadvertently causing my app to come under greater scrutiny and review.


Adapted from original October 2013 publication in PM360

Contact Cerulean for expert help Part 11 today