Maybe you’re one of those people who says, “That FDA—they never listen!”. Or maybe you say, “If the FDA wouldn’t wait so long, we could see products come to market sooner!”. Well, glucose meters and test strips are not made in a day. Okay, maybe they are, but bear with me here.
The U.S. Food and Drug Administration (the FDA) is in the midst of an arduous process to update guidance to companies on future manufacture of blood glucose meters. From the Strip Safely website:
“FDA has two draft guidance documents about blood glucose meters that are open for comment until April 7, 2014. A “draft guidance” is basically a preview of what standards the FDA is considering requiring in order for blood glucose meters to be cleared — the law requires that FDA open its draft guidance documents up for comment before publishing a final version.”
So if you’re one of those people who says, “That FDA—they never listen!”, here’s your chance.
The FDA has two open dockets right now through Monday, April 7th. You have an opportunity to raise your voice with the rest of the Diabetes Community, engaging in public discourse and helping the FDA get it right.
The best part is, it’s so easy to lend your voice to this important issue. As usual, Strip Safely has everything you need to know. And not in a creepy, big-brother, overbearing government kind of way. Head on over there now and you’ll find super easy instructions that will help you lend your voice to this increasingly critical guidance.
(hint: read the instructions carefully, or you might miss something important)
If you’re worried about not having enough time to comment, don’t. Strip Safely has links to the dockets for personal use meters and in-clinic meters. And they even have language you can use to join the chorus of D-people who are weighing in on this topic. After rewriting part of the prepared comments and submitting them to the FDA, I looked at my watch to find that a mere fifteen minutes had gone by from start to finish.
If you’re worried about your privacy, don’t. You can submit your comments anonymously. Or you can give them your name and e-mail address. Your choice.
If you’re worried about not making an impact, don’t. We need to submit as many comments as possible. More comments get more notice, making more of an impact. And after April 7, we may not get the chance to comment on this for another ten years. That’s the way it works at the federal level, folks. Your voice on this topic is appreciated and valued and necessary.
One other thing: After you submit your comments, don’t forget to tell everyone you know that the FDA is accepting public comments on guidance for over-the-counter blood glucose meters, and meters designed for healthcare providers in an office or hospital setting.
It’s not often you can do something tangible that you know will have a positive effect on People With Diabetes for years to come. But you know what? This is your chance to do just that. It’s easy. And we need you.
Many thanks to Christel Marchand Aprigliano and Bennet Dunlap for leading the charge up the Hill of Guidance.
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