Comment by Don on October 5, 2011 at 5:46pm

Interesting, I have no idea what kind of comment I would make other than please don't make the approval process expensive or long! I guess this would affect the Jewel pump, Cell Novo pump, Dexcom's plans to someday transmit to smartphones, and C8 MediSensor's C8 glucose monitor system.

Comment by Manny Hernandez on October 12, 2011 at 9:57am

Here is a sample comment that may come in handy. You are welcome to tweak it and use it as you see fit or not.

Thank you for the opportunity to comment on Mobile Medical Applications. I live with diabetes (or "I have a loved one with 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 other systems. 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.

Comment by E-J Ohler on October 12, 2011 at 1:30pm

Here is another comment I posted with the FDA

As a long time (45yrs) Type 1 diabetic many good new products have come to market to better manage this disease.
Two of these are the Animas Insuline Pump (J&J) and the Dexcom Continuous Glucose Meter (CGM) Currently in Europe these two fantastic mobile items have been rolled into one called the Vive This item has yet to be approved by the FDA for use her in the US. What is the hold up??
This item would enable a diabetic to live a healthier less costly (to society) life with one mobile item that is waterproof instead of two. This is a no-brainer. Both sub items have been approved and in use for years here in the US so rolling them in one casing/item to wear for the patient should be easy to approve. This is not a drug that needs years of testing all testing has been done for both the pump and the CGM already.
take a look www.youtube.com/watch?v=hgtuoFVKFds

Comment by cyborg mom on October 14, 2011 at 7:51am

I have had type 1 diabetes for 40 years. I have lost one job due to having a reaction that scared my boss.
I chose to leave another because my new physician put me on an insulin pump and helped me lose over 100 pounds. Today I am just looking for tighter control which can be provided by putting the Dexcom Continuous Glucose Monitor with either the Omnipod Insulin Pump or the Animas Insulin Pump. Both of these are made in the U.S. but only approved for use in Europe. Come on FDA these are both approved for use. Approve the new technology to help us be better more productive people in the U.S.

Comment