After writing here for 3½ years, I can tell you that there is no shortage of people who like to add their two cents on a subject. Whether it’s insulin costs or the importance of Medicare coverage for CGM users, the Diabetes Online Community knows how to speak up when asked.
Here’s something you may not have heard of yet, and it’s tailor-made for you to learn something and speak up too.
On September 29 and 30, the U.S. Food and Drug Administration is hosting a public workshop. The workshop is geared toward the discussion of patient labeling on medical devices, like insulin pumps and continuous glucose monitors (and maybe artificial pancreas systems?). To be fair, it is not specifically diabetes related, but discussions at this event could certainly have implications for People With Diabetes.
The workshop will be held at FDA’s sprawling White Oak campus in Silver Spring, Maryland, outside of our nation’s capital. The two day agenda includes presentations from FDA staff and others, and will cover things like FDA’s development and review process, new approaches to patient labeling that aren’t necessarily paper-based, user assistance information, and more. I really like the way day two begins, with a session on Identifying the Gaps in patient labeling, followed by a session on Closing the Gaps in patient labeling.
If you live in or near Washington, D.C., this is an awesome opportunity to not only find out more about patient labeling of our devices, but actually join in the discussion too. Let me give you the link so you can find out more:
CLICK HERE to find out more and register for this public workshop
Also: Although there are no details yet, FDA says that there will be a webcast of this workshop.
So… for everyone who says, “What can I do?”, my answer is this. You can do this. You can listen in, or attend, in person, this public workshop. You can take notes. You can form your own opinion. If you are there in person, you can speak on behalf of all of us who are living with or affected by diabetes. When it’s over, you can tell everyone you know about what happened and what was discussed.
And I will be thankful you were there for me.