How many mobile medical apps have received 510(k) clearance from the FDA? It's a question I get asked often. For a while the standard response that I've given and heard others give was that you could count on two hands how many apps have received FDA clearance. Over the course of the past two years, however, it has become clear that an increasing number of wireless-enabled medical devices with companion apps were securing FDA clearances. Based on a review of the MobiHealthNews archives, but more importantly, the FDA's database of summary decisions for 510(k) clearances, we have found more than 75 510(k) clearances that included a mention or description of a mobile software component -- and compiled our findings into our latest MobiHealthNews Research report: 75 FDA Regulated Mobile Medical Apps.
In the FDA’s 2011 proposed guidance document for the regulation of mobile medical apps, the agency defined a mobile platform as a commercial off-the- shelf computing platform “with or without wireless connectivity” that is handheld. The agency defined mobile apps as software that can be run on a mobile platform or a Web-based software application that is designed for the mobile platform. Like most technology definitions these are far from perfect, but they guided the parameters we used to find the more than 75 regulated apps featured in our latest report. The earliest group of cleared apps from the late 90s and early 00s ran on various Palm Pilots or "palmtop" PCs. The word "smartphone" began appearing in 510(k) clearances seven years ago when AirStrip Technologies first received clearance for its OB app.
Are there more than 75 cleared mobile medical apps? In all likelihood. We only included medical devices that specifically included mobile software components in the summary description of their FDA clearance. Devices may have included these references in their official applications, but for whatever reason the mobile references didn't make it into the summaries that were subsequently made publicly available. Also, there are a few examples of devices that have companion mobile apps -- like Raiing's companion app for its Bluetooth-enabled thermometer. The company's FDA summary makes no mention of the app so we decided the app could not be considered FDA cleared. There are many devices that have Bluetooth or other wireless connectivity that may have companion apps, too.
Most FDA cleared apps are focused on chronic condition management -- often taking the form of a digital logbook that receives data from a companion medical device. This group includes diabetes, asthma, and blood pressure management apps. The next largest contingent of FDA-cleared apps are related to electrocardiographs (ECGs), and typically take the form of a remote, mobile viewer for ECG data. Vital sign monitoring apps, imaging apps and medication adherence apps round out the group with a few apps that don't fit any of those categories.
One metric that seems to bubble up in every discussion of FDA regulation is time to clearance. While the official time to clearance is different from the actual time to clearance -- our analysis shows that the time from the official application submission to the decision date is actually shorter by almost a month for devices with some kind of mobile component. Of course, if you ask some of the early mobile health companies that went through the FDA, they will tell you it didn't really take three-and-a-half months, it actually took years in some cases to prepare their submission.
MobiHealthNews' analysis of 75 FDA Regulated Mobile Medical Apps is available in the MobiHealthNews Research Store today. If you are looking to better understand the types of apps that have already received FDA clearance, be sure to get your copy!