December 10, 2013

of Dexcom, FDA and Pump Integration

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.

Please, listen to the call for more accurate insights, this is a blog on the internet. Also in the full disclosure department, I own shares of Dexcom and Tandem.


  1. Does that apply to software integration as well? I'd like to see Dexcom data integrated with t:connect. I don't necessarily need/want the CGM integrated into the pump itself.

  2. Don't know. Good question. My bet would be (and this is not in anyway an informed viewpoint) that since t:connect is Tandem product the ball fall to them and it would follow the pump integration but what do I know.

  3. I would like to see Dexcom with Omnipod. I love both my Omnipod and Dexcom and them together would be so much nicer!!!

    1. Not sure if the Anonymous commenter will see this, but Dexcom and Insulet called it quits about 10 months ago - see . Hoping to learn what Insulet is up to when I go to ATTD in Vienna in the first week of Feb (2014).

  4. Thank you, as always, for explaining things like this. :)

  5. Thanks for the explanation and update, but ugh, another 6 months? I was thinking approval would be any day since they submitted for approval in April or thereabouts. I just can't fathom why this is still taking as long as it has. Medtronic has had an integrated system for years now, so why can't they point to that, and do the 501 thing? My anger about the continued wait for the mythological Vibe is indescribable at this point. It's not like any of this is new tech... grr.

  6. Regarding the software/data bit, I wonder if it would be affected at all by the whole display of data vs. interpretation of data and need a separate FDA approval for that.

    And like Lee Ann I am feeling Vibe pains and I have only been waiting since April 2012.