The FDA Gets It Right

The FDA Gets It Right

Yesterday the FDA issued final guidance for medical mobile apps and shock of all shocks did not go overboard. For an agency that’s been overly conservative these guidelines are very clear and not overly zealous. That’s the good news however the news isn’t all that good for diabetes device and even diabetes drug companies as they will not escape regulatory scrutiny. According to the guidelines apps that control an insulin pump or work with a glucose monitor will be subject to regulatory oversight.

On the flip side apps that help a patient track their glucose readings, insulin intact or medication adherence appear to have escaped regulatory oversight. While this is welcome news it could create a dilemma for companies where the app not only tracks information but makes therapy recommendations. As we have noted many times there are several apps which use information entered by the patient, combine that information with data gathered by a glucose meter and recommend an insulin dose. These apps are basically copies of the bolus calculator function that is found on today’s insulin pumps.

This brings up another interesting point given how diabetes device companies try and protect their intellectual property. Could for example Medtronic (NYSE:MDT) sue the maker of an app who’s main function is bolus calculation or will the app maker be protected because the app is not contained on a pump?

Overall Diabetic Investor is pleased with the clarity and detail of the guidance. Companies will now have a clearer understanding of the regulatory pathway which is a welcome departure from having no guidance whatsoever. The simple fact is the mobile world and diabetes management have been merging for many years, a trend that will only accelerate now that the FDA has issued their guidance. Hopefully the agency will continue this trend of providing clear and understandable guidance to new diabetes drugs and devices.  That truly would be a breakthrough and welcomed throughout the diabetes world.