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 proposing lessening the regulatory process for MDDS as they introduce little additional risk. I agree.
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 don’t 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.
So far there are two (2) comments on the FDA docket. That seems hardly enough.
In my view one way the diabetes community can get attention is to speak up in droves when FDA is listening. MDDS isn’t the sexiest subject in the world, neither are food labels (http://diabetesadvocates.org/tell-fda-your-thoughts-on-the-proposed-nutrition-fact-label-by-aug-1/) but if we don’t show up when the policy makers are listening how can we claim we need to be heard?
Please comment on food labels. The docket is open to August 1.
Comment on MDDS, it is open August 25.
Let’s get policy makers attention. Let’s put a show making of comments into the dockets.
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 proposing lessening the regulatory process for MDDS as they introduce little additional risk. I agree.
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 don’t 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.
So far there are two (2) comments on the FDA docket. That seems hardly enough.
One of the keys to successful advocacy is getting attention. I have talked a lot about how much I love the paper Back to Basic as a model for diabetes advocacy. Now the book is a block buster summer movie. (OK part of the paper is in this Youtube 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 isn’t the sexiest subject in the world, neither are food labels (http://diabetesadvocates.org/tell-fda-your-thoughts-on-the-proposed-nutrition-fact-label-by-aug-1/) but if we don’t show up when the policy makers are listening how can we claim we need to be heard?
Please comment on food labels. The docket is open to August 1.
Comment on MDDS, it is open August 25.
Let’s get policy makers attention. Let’s put a show making of comments into the dockets.
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