Like a lot of folks I have been waiting to see the Dexcom CGM integrated with insulin pumps to provide a better system for people with diabetes. Like a lot of folks I am a tad (a word that here means "a whole lot") impatient.
I heard an interesting explanation of some of the processes today in a Dexcom presentation at the Oppenheimer 24th Annual Healthcare Conference by Steve Pacelli EVP of Dexcom.
19:55 into call if you want to listen along at home.
The gist of the comment was that the pump companies have lived in the regulatory environment of 510(k) approval. The pump sensor combination is viewed as a system by the FDA (just like I do in the first sentence of this post.) Systems falls under a PMA approval process at FDA. About the PMA process Steve said for, “these pump partners, their world dramatically changes when they incorporate CGM into their solutions.”
What the hell is the difference between 510(k) and PMA you ask? Good question.
Here goes. 510(k) is substantially equivalent to some already approved device. PMA is a more robust evaluation. I'll make the grossly overly simplistic comparison that 510(k) is like sayin, "Yo! FDA. Our thingy here is like that other thingy over there. You approved it and so since we are like it, we should be approved too," and PMA is turning in a full term paper, with APA formatted footnotes, to a bear of a grader.
A FDA web site says this:
“A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA).
“Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses.”
Pacelli goes onto talk about some of the PMA documentation required including testing, validation and quality systems.
Don’t care much about regulatory paths? Fair enough. Steve continues to think that Animas will complete FDA questions in January putting an approval in teh middle of 2014 and t:slim filing in Q1 and maybe getting an approval in late Q4 2014 or early 2015.
Actual regulation times may vary. LOL.