Here at Klick we’ve created a lot of mobile experiences, from simple responsive design web sites to optimized web experiences to mobile apps on all three major mobile platforms: Blackberry, Android, and of course iOS. We’ve created trackers, interactive demonstrations, and simple information sites. As clients become more familiar with the mobile channel we get more questions about the draft FDA guidance on Mobile Medical Apps.
A congressional hearing on the FDA’s regulation of mobile medical apps wrapped up on the 21st (video of the final day is available) and it shed a small amount of light on the issues important to health marketers who are creating apps.
The folks over at Rock Health (a venture capital company) have put together a SlideShare based on these hearings and what their startup companies have learned. This deck takes out some of the guesswork inherent in the process and is a great addition to the industry conversation.
At pharmaceutical companies, regulatory groups may be wondering about the much-discussed 510K process for getting mobile medical apps approved, and marketers may be worried about this, but the issues are containable.
Average Time: 67 Days
According to Christy Foreman, Director of the Office of Device Evaluation at the Center for Devices and Radiological Health, the average review time for a mobile medical app is 67 days. This is after approximately 100 apps have gone through the process, so the FDA is well-versed on helping companies do this.
All Apps are Class I or Class II (so far)
This makes sense as most apps are simple trackers or dosing tools. These types of apps have paper analogs and don’t interact with the patient directly. If we give IBM’s Watson access to a surgical robot that might be a different story.
Rock Health Illustrates the Process
For companies going through any government process for the first time there can be a steep learning curve. Rock Health’s deck is an excellent resource and highly recommended. One of the slides shows the process in summary:
It’s Just a Draft Guidance
Yes, it’s just draft so far, but it will be a full guidance by October of 2013 according to Foreman. This point was well-defined after some pointed questioning so there is a reasonable chance the date will stick (but I would never guarantee a date from the FDA).
If you have a mobile idea, it’s important to look at the project from a benefits perspective first rather than dwelling on the regulatory issues. If an idea is worth doing then the regulatory hurdles won’t derail it, they impose some additional regulatory time, but that should be containable.
In a world that is ever more mobile this isn’t an optional piece of learning for an organization. Assuming that Congress doesn’t pull the ability for the FDA to regulate mobile medical apps, every pharmaceutical company will eventually have to go through the process. Today is as good a day as any to get started.