FDA has a docket open seeking public comment on Medical Device Data Systems (MDDS.)
What is that you ask? Good question.
A MDDS is a systems that, in the FDA words, facilitates, the electronic transfer or exchange of medical device data from a medical device, without altering the function or parameters of any connected devices. In other words provide second screens for information. FDA is proposinglesseningthe regulatory process for MDDS as they introduce little additional risk.
For people with diabetes this may mean seeing our information on additional screen such as our phones.Go FDA!
The guidance speaks directly to mobile.
It is unclear how CGM data is viewed for this data. FDA specifically draws a line at active patient monitoring in the guidance. They dont exactly say what that is. In my view is that is meant to be in clinic critical care monitoring, not patient self monitoring such as CGM.
I hope to help FDA make that distinction by sharing my views.I would love some company helping FDA see how PWD feel about information.
Diabetes Advocates, many from the CGM in the Cloud Facebook Group, have posted almost 300comments on the FDA docket. That is a clear signal but more is better.
One of the keys to successful advocacy is getting attention. I love the paperBack to Basicsas a model for diabetes advocacy. Now the book is a block buster summer movie. (OK part of the paper is in thisYoutube video from MasterLab.)
In my view one way the diabetes community can get attention is to speak up in droves when FDA is listening. MDDS isnt the sexiest subject in the worldbut if we dont show up when the policy makers are listening how can we claim we need to be heard?
Comment on MDDS, the docket is open August 25.
Lets get policy makers attention.