Wow! My last post really piqued your interest. Thanks to everyone for well over 100 comments posted and many more conveyed through email. I have read through all of them and there are some great ideas and questions in there. Because of the interest and because we are going to be asking our advocates to increasingly get involved in regulatory issues, this post is going to give you a brief overview of the regulatory system in the U.S., focusing on medical devices.
FDA is organized into Centers that have responsibility for specific types of food and medical products. Three Centers have involvement with diabetes products:
Center for Drugs Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
Within CDRH, one unit has responsibility for insulin pumps and artificial pancreas systems while another oversees SMBG meters and CGMs.
FDA uses a three-tiered classification system to regulate medical devices: class I devices are simple products and have lowest amount of regulation (e.g., bandaids) and class III devices are complex products that have the highest degree of regulation (e.g., heart valve).
Insulin pumps and SMBG meters are class II devices. This means that a manufacturer has to get a clearance through FDA before they can sell the device to patients. To do this, they submit what is known as a Premarket Notification, or 510(k) application, to FDA that includes data and information showing that the new device is very similar to a device already on the market. A 510(k) usually includes laboratory data and sometimes also includes clinical data.
CGMs are class III devices as are artificial pancreas systems. Manufacturers must submit a Premarket Approval (PMA) application and get approval before being able to make these available to patients. A PMA must show the device is safe and effective through laboratory data as well as data from at least one clinical study.
So, that’s the basics. There is a lot more I could cover if there is interest, so let me know if this is helpful and if you’d like to see more in the comments below.
And, don’t forget to tune into Aaron Kowalski’s webcast about the Artificial Pancreas Project in a week – March 8 at 1pm EST.
Thanks for the background info!
I don't understand the logic of pumps being class II and cgms being class III. Should be the reverse, considering pumps actually deliver insulin and are meant to "replace" one of the functions the pancreas in a way, while the cgm is the equivalent of testing with a meter every 5 minutes.
But I realize there are many things about the FDA that just don't make sense.
Why has the FDA cracked down so hard recently on allowing new cgm devices to be approvved? Seems like they are making it very difficult even for new diabetes management software to be approved. Almost makes it impossible for smaller companies to afford to do the studies required. They are slowing down the process to beet control.
I'm sorry but I'm confused. The pump and the artificial pancreas are a type II device requiring FDA approval before it is sold but the CGM device which actually gives the input to the artificial pancreas does not as a type III device. That's like approving a car but a major component like the brakes does not. Just last night I was awakened by my CGM/pump telling me my BS was very low(70). It wasn't even close. My meter said my BS, taken at that time, was 175 and as far as I could tell, it was definitly not low. I think the artificial pancreas is a great step forward but its data input, as far as I can tell needs vast improvement. If I relied then on an artificial pancreas I'd probably be dead!
Why are CGMs class III whereas Insulin pumps are class II?
The CGM is rather passive by nature, providing information only, whereas the pump is active in that it 'treats' the condition and thus has the potential to over- or under-treat and cause problems.
Logically it would seem the pump is much closer to a heart valve in class than a CGM, at least by itself.
Granted, when a CGM is combined with a pump in an artificial pancreas system, the whole system is somewhere between a pump alone and a heart valve in terms of it's riskiness and potential need for regulation, but by itself a CGM is just a data source that doesn't seem to fit the class III certification.
Can you explain this?
Is it because the CGM is still relatively new?
Great info. If possible can you post what stage Animas/Dexcom pump CGMS is? Also, is the Navigator still in the mix? If so, will it combine with a pump, and at what stage is that in?
Thanks, Linda
What entity will pursue the submittal of a PMA application for the articificial pancreas & what is the status?
why would an insulin pump be rated a II but a CGM is a III? Isn't an insulin pump a more complicated device? by giving the CGM's a III rating, isn't it a lot harder to get things approved by the FDA?
How can I get involved in the study in England, medtronic only outside the USA. I am looking to exspeadiate the research into the closed loop system. I am exstreamly brittle diabetic. Iv worn pump 20years & cgm 10yrs. Hense I know many of the difficulties facing the closed loop system. Plus being a worst case senerieo. I believe with my knowledge in many system faluires. I could trouble shoot future problems. I also have knowledge in EE, & EET. Thank you!
Thanks for the information. It really is helpful.
Thanks for these clarifications. Do you know why the smaller, lighter Omnipods are still sitting on a shelf waiting for approval when they are essentially the same as the original Omnipods, only smaller?
Thank you for this post on the basics Campbell, it is very helpful.
I agree with most of the other commentors so far - seems weird that a pump is class II but CGMs are class III.
March was our busiest month yet! We launched our first activation of the year, and I want to make sure