This blog post was written by Deniz Temelli, Business Analyst at TechAlliance.
With over 17,000 medical mobile apps currently available, the biotech startup community has been asking a lot of questions about pending FDA regulations in this emerging space.
What kind of apps would be regulated? What would the requirements be? As of September 25, 2013, we finally have answers to these questions thanks to the long-awaited FDA mobile medical app guidance document.
There has been a lot of debate over whether or not mobile apps should even be regulated as medical devices – a debate which is nicely summarized in a post by Software Advice, an online resource for medical software.
Software Advice also recently conducted a reader poll where only 68% of respondents were in favor of medical app regulation. People are not unanimous on the issue and the debate will likely continue for some time.
Personally, I feel that there are apps out there that definitely need to be regulated from a patient safety perspective, especially considering the shockingly poor diagnostic accuracy of some skin cancer detection apps.
Of the 17,000 medical apps currently available, only 75 are FDA approved. It’s obviously impossible to regulate them all, and the FDA is clear in their guidelines that they only want to regulate apps that could have an impact on patient safety if they were not to function as intended.
According to the new regulations, the following apps are considered medical devices that would require regulatory oversight (see here for specific examples):
- Apps that turn the mobile device into a medical device itself
- Apps that are intended to be used as an accessory to a regulated medical device
- Apps that display, transfer, store or convert patient-specific data from a connected device
The regulations also specify which types of apps are not considered medical devices and therefore require no regulatory approval. This would include medical reference apps like dictionaries and textbooks, medical training tools like flash cards and training videos, patient education apps, and apps that automate general office operations for a health care facility.
Finally, the regulations acknowledge a grey area in which is it difficult to say whether an app is a medical device or not when considering the broad category, therefore the FDA has reserved judgment on a case by case basis. A full list of examples can be found here but some notable ones are:
- Apps that provide prediabetes patients with guidance on how to develop better eating habits or increase physical activity
- Apps that keep track of medications and provide user-set reminders to increase medication adherence
- Apps that provide education, reminders or motivational guidance for individuals trying to quit smoking
For many entrepreneurs with a medical app idea, the details and requirements of medical device regulatory approval can seem very daunting and most don’t appreciate the time and money required for approval or even that approval is required at all. However, despite it taking a few years to get published, the FDA is very upfront about their regulations and mentions multiple times throughout the document that anyone who is unsure about what category they fall into can contact them directly to discuss what requirements do apply. For anyone working in this space I would strongly advise that this be one of the first things you do as it’s always better to plan things advance than put out fires along the way.