The big story last week was the “it has come to our attention” letter from the FDA to Biosense for their uChek app that uses the built-in camera of smartphones to interpret urine test strips. There are three reasons for the FDA to be aggravated by Biosense over this app:
Clearly a regulated app
Based on the draft guidance issued by the FDA two years ago (July 21, 2011) this app is clearly a “mobile medical app” based on the FDA’s definition:
When the intended use of a mobile app is for the diagnosis of disease or other conditions, … the mobile app is a device.
The automated reading of urine test strips is clearly an activity that is intended to diagnose (or at least provide input to) disease or other conditions. The FDA believes that Biosense needs to acquire clearance to market this app through their normal process.
Biosense apparently does not agree and has broadcast its interpretation of the rules far and wide:
- On it’s FAQ page, Biosense claims that the app is already registered as a Class I device and it only to be used under the supervision of a medical professional.
- On it’s Facebook page, Biosense has posted its side of the story and is promoting the stories that surface, such as the latest MobiHealthNews post.
This type of unrepentant behavior is rarely tolerated by regulating bodies such as the FDA as, left unchecked, it undermines their authority.
The difference of opinion
The difference comes down to whether the app is a Class I device, as Biosense apparently believes, or is potentially a Class II, which seems to be the FDA’s position. Since the FDA clearly has precedent that it believes interpretation and measurement apps are Class II with its mention of glucose meters in the draft guidance, it is unlikely that it will be satisfied with Biosense’s interpretation.
Also, part of Biosense’s interpretation seems to be that they feel the app is only used under the supervision of a medical professional. Since the app is available on the Apple App Store (link active as of May 31, 2013) for free download by anyone with an iPhone this seems like a very weak argument from the manufacturer.
Further, another question is whether the camera will pick up the colors on the strips and interpret them correctly. It is unlikely that the FDA will accept standard app testing as qualification of the device for accurate color measurement under all of the different lighting conditions a user would find in the home environment.
Implications for pharmaceutical marketers
If you are planning, or have an app in market that automatically interprets any form of signal (visual, auditory, etc.) and provides this analysis to the user you need to get it reviewed by the FDA. The first part of that process is to open the lines of communication and get a Class designation by the FDA.
Consider this letter a “shot across the bow” and take action now so your patient apps remain in market. The first step may be a 513(g) Request for Designation (provided by Digitas in a recent document).
Want help? Klick Health has experts available to help you with all aspects of mobile medical app. Just contact us to get the process started.