Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions
I attended my first AdvaMed MedTech Conference in early October, and it was an awesome opportunity to interact and learn from the industry. There were many things I learned about the medical device industry, but one thing that really stood out for me was a session on mobile medical apps.
A few major questions arise from this hot-button topic:
- What type of quality system would mobile medical app developers need to follow?
- How do you intend to market the application?
- How do you accommodate a feedback loop or adverse event reporting when consumers are driving use of the application?
What type of quality system would mobile medical app developers need to follow?
The FDA’s outlook on mobile medical apps seems to be a delicate balance between maintaining a focus on patient safety (which drives the need for regulation) and encouraging innovation. This is why they are only regulating certain apps that are considered class II or class III, which differs from how they regulate all classes of medical devices themselves. Similar to the tri-level classification for medical devices, mobile medical apps also fall into 3 distinct categories: apps with low-risk for patient safety are unregulated, a middle segment qualifies as medical applications and are not regulated but are “enforced with discretion,” and the final category is mobile medical apps that are regulated. When a mobile medical app falls into the “enforced with discretion” category, manufacturers do not need to submit premarket applications nor do they need to register or list their apps with the FDA.
With this in mind, quality system regulations for mobile apps are likely to be a stripped-down, bare bones version for most applications, with the exception being those that are most dire in their function as a device, just as a class III medical device is more highly regulated than class I. Now, keep in mind we are talking about regulating software development instead of medical device manufacturing. When writing the software, there are components that need to be documented, controlled, and tested—but currently there are no explicit regulations for these processes. This minimizes the reach of 21 CFR part 820 (design controls, purchasing controls, production controls, acceptance activities, nonconformances, CAPAs, labeling and packaging). But there will still be considerations that need to be consistently documented and managed to ensure the mobile medical application functions as intended.
How do you intend to market the application?
When you think mobile apps, the first thing that probably comes to mind is a smart phone. Mobile medical apps, however, are categorized or regulated based on functionality, not on their platform. Regardless if the application runs on a smart phone or a toaster oven-sized device, any regulations would focus on what it does, not where it does it.
A common theme repeated at AdvaMed was “how will this be marketed?” which directly relates to functionality of the app. To the FDA, how the application is marketed is more important than what the app actually does. For example, if an app is designed to take your temperature, it can be marketed for all to use as a general health and fitness application. But if the app is marketed as a means to diagnose or manage a disease, like identifying flu-like fever patterns, the application itself is far more likely to fall into the realm of an FDA-regulated mobile medical app. For a more in-depth look into this, here is a great article that provides examples of diabetes mobile medical apps, and which scenarios would qualify as regulated apps.
The good news is, when in doubt, you can contact the FDA and they will have a response for you within approximately three weeks with a determination on whether an app will need to be regulated and therefore require premarket applications and registration with the FDA.
How do you accommodate a feedback loop or adverse event reporting when consumers are driving use of the application?
Great question, but the answer is still to be determined. Some of the ideas that were brought up at the AdvaMed MedTech conference included:
- Users can automatically email the developers from within the mobile medical app to report an issue.
- Users can log a report from a button within the application.
FDA direction on medical mobile apps
With all these questions surrounding the topic, a few things are clear indicators of the FDA’s ongoing direction on this topic. The final guidance document was released in September 2013, and the information shared at AdvaMed 2014 follows in the same direction. The FDA wants to encourage innovation in developing mobile medical apps, but remains loyal to its core value of product and patient safety. Conceivably, this is why the category of apps that fall under enforcement discretion are given the opportunity to reach the market without the structure and process of premarket applications or registration. It will be interesting to see how mobile medical apps continue to evolve in the coming years, as more and more applications in general are released across the globe.
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Do you have another take on this topic?
Have you read any great articles or opinions on quality systems for mobile medical apps? If so, please post your comments below. In the meantime, here are some sources to check out for more information on this topic:
- Mobile Medical Applications information
- Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff