D-Data Community Comments for FDA MDDS DRAFT Guidance-Your input/comments needed!

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Jul 21, 2014, 3:49:25 PM7/21/14
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Hi all - I would love your input on a new draft regulatory guidance issued recently that could make apps like Nightscout more readily available. On June 20, FDA released a new, draft guidance document outlining their current thinking on how they plan to enforce regulations related to Medical Device Data Systems (MDDS), which builds on recent agency thinking expressed in the FDASIA HIT report released in April, 2014 and the Mobile Medical Applications (MMA) guidance document released in September, 2013.

The new draft MDDS guidance proposes the agency use their 'enforcement discretion' to essentially de-regulate many medical device data systems, which include a variety of software applications used to view, track and analyze health data generated by medical devices. This is good! It's a move that D-advocates have been advocating, which could free up device companies and third-party developers to create more useful software for us to access our device data and better manage our care.

The agency wants and needs to hear from the diabetes community about the draft guidance, and we need your support. While the direction of the draft guidance is distinctly positive, there are many points that still need to be clarified.

Diabetes patient/caregiver advocates Anna McCollister-Slipp, Bennett Dunlap, Amy Tenderich and Howard Look will help lead a discussion between the diabetes patient community and the FDA in the coming weeks. We would LOVE your input and participation in the call and dialogue. And as a community, we will NEED your input on the guidance. The more submissions we have from patients/caregivers to the federal docket, the better.

We are making progress, but we need broad community support to push these efforts through to fruition. Below is a link to the questions we have begun drafting. If you're interested in adding questions or participating in a call with FDA on these issues, please email me directly at anna...@gmail.com.



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