FDA outlines flexible approaches for artificial pancreas system clinical trials, product approvals

The U.S. Food and Drug Administration today issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes.

To facilitate development of this novel product in an evolving area, the draft guidance provides flexible recommendations for design and testing that meet statutory requirements for safety and effectiveness. For example, the draft guidance provides for flexibility in choice of study endpoints, number of patients to be studied and the length of the clinical trial.

“The FDA is focused on improving the process for the study and approval of artificial pancreas systems, and developed this guidance to provide maximum flexibility to manufacturers seeking to bring this device to U.S. patients,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “We understand how this device could change the lives of millions of Americans with diabetes, and we want our safety and effectiveness review to give patients the confidence that the device works.”


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I think the question of getting medical technology into the hands of people who need it, while taking the time to ensure it is safe, is a really interesting one. Obviously an artificial pancreas malfunction could have much more dire consequences than a lot of other drugs and technologies the FDA considers. I'm excited to hear what the TD community thinks about this...?

I think that this is an odd case. Perhaps a precedence hasn't yet been set for artificial organs in quite this way before?

I mean, we have pace makers and artificial hearts, but perhaps nothing that delivers hormones while using artificial intelligence.

I'm a little concerned the FDA, even though having cleared the CGM will kick it out based on the fact that it isn't yet accurate enough.
This device they're talking about. It's the Revel with an auto stop feature. Am I right? Hardly an artificial pancreas but it's that first step in the right direction kind of situation...
The paradigms do have an auto off after no input feature that you may or may not use, but again, it lacks that synthetic intellect making the call for you, so no legal issues.


Ironically, due to the various getting to know you glitches the CGM has, I would have turned that auto stop on low feature off a long time ago :D

They are going to post something upon which to post comments in a couple of days!! Heh heh heh...*awaits black helicopters*

My Endo, Howard Wolpert wrote an interesting essay on such progress.


I also think for those of you concerned about accuracy on the CGM, this is an interesting read as well..


I plan to get back on the Pump again soon, and the CGM again in the next month. I was not skilled enough for both at once and got burned out.

Thanks for posting - very interesting. Lays out the issues pretty well.

nice to see the fda is doing something..right now..