FDA mobile medical applications draft guidance

Mobile Medical Applications (MMA) are software applications that run on mobile devices such as smartphones. Smartphones and like devices have become powerful enough to run critical and complicated software applications making them useful as accessories to medical devices and in some cases a replacement for a medical device, specifically when the medical aspect is the software in question and the device is the platform it runs on. The FDA recognizes this and has offered a draft guidance document which aims to clarify oversight requirements including who and what the FDA could regulate. JDRF is interested in this guidance as MMA have a significant role in the future of diabetes management. Diabetes requires self-management and mobile diabetes therapies and devices. MMA can contribute immensely to the discretion and adherence of diabetes therapies as well as provide communication capabilities that are not available in current diabetes device technologies.


“Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications – Draft Guidance” – Document issued on: July 21, 2011 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm263280.htm

Ramifications for Individuals with Type 1 Diabetes:

The use of Smartphones and like devices in diabetes management provides the opportunity to centralize diabetes care information and individual data, and communicate and share that information as necessary to improve patient care, safety, and discretion. The draft guidance attempts to provide clarity to industry around FDA oversight. The appropriate oversight will create an environment where safe and impactful MMA’s can be developed and delivered to patients in a timely manner.

JDRF Involvement:

JDRF has solicited feedback from key opinion leaders in the field of MMA to determine the impact of the draft guidance and determine if clarifications are necessary to allow for the greatest positive impact of the guidance. JDRF has also participated in a FDA workshop and panel discussion to provide feedback on the guidance and express the importance and necessity of MMA in type 1 diabetes. JDRF will also be responding to the FDA call for comments.