October 13, 2011

Dear FDA It is Me Again, Again.


If you scroll down a few post you will see my two bits on FDA regulation of mobile apps. Here is another form letter you can feel free to edit and use to comment. It runs a bit over the 2000 character limit on the FDA site so edit away.   

Thank you for the opportunity to comment on Mobile Medical Applications. I live with type 1 diabetes (or "my child lives with type 1 diabetes"). I try to live a useful life not limited by diabetes. To that extent, mobile medical applications can be a great help. Through guidance, the FDA can help improve our lives by facilitating a robust mobile device ecosystem.   
I and others like me use many portable medical devices to manage type 1 diabetes; insulin pumps, glucose meters and continuous glucose sensors. Each as its own software. None of those systems are capable of sharing the diabetes information with systems made by others. 
Diabetes care is all about balancing blood glucose with insulin, food and activity.  The Diabetes Control and Complications Trial (DCCT) showed that tighter control leads to healthier lives. Applications can combine data from multiple devices to help give insight into the whole of diabetes care. Mobile apps offer the promise of accurately combining the information from different diabetes management tools, the correct formulas and analysis from the care textbooks into wizards that can help manage diabetes to the standards of DCCT.  
Recent articles in the New England Journal of Medicine call for “Balancing Regulation and Innovation” (Curfman and Redberg, 9/15/2011) and the need for “Creating a New Regulatory Framework for Moderate-Risk Devices” (Challoner and Vodra 9/15/2011) As a patient whose life depends on devices I am frustrated to learn that innovative US designed and manufactured products are available overseas but not here.  "A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and Implications for Reform" shows that three quarters of the firms bringing innovation to heath devices do so out outside the US first. (Linehan, Ph.D. Northwestern). As the FDA considers guidance for mobile applications I encourage the adoption of regulatory models used in the EU that balance regulation with improving heath care.   
Thank you for taking into consideration this comment. They are made with the hope to improve the lives of people with diabetes.

1 comment:

Jackie said...
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