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Medical Devices · FDA Regulation

Why is the FitBit not a Class 2 medical device if diabetics use it to monitor glucose levels?

Ken Steinberg Innovator and Serial Market Disrupter

June 30th, 2016

Here is the first line from FitBit's Facebook page.  

"Many of our Fitbit community members use the tracker functionality to monitor their blood glucose levels."

Why does the FDA not require this to be classified as a medical device?  Is this just marketing?  If someone is using it to determine their blood glucose level to then administer insulin, then this would be the same as a BGM (blood glucose monitor).  Ihaven't read their legaleze so perhaps there is a clause that absolves them but this sure is a fine line.

Your thoughts?

Bob Troia Entrepreneur. Builder. Creative Technologist.

June 30th, 2016

Fitbit doesn't do the actual glucose monitoring/tracking - their website simply allows people to track other data beyond what their fitness trackers provide by manually entering it in. No different then Apple's HealthKit allowing users to input glucose data or pulling in readings from other devices.

Ken Steinberg Innovator and Serial Market Disrupter

June 30th, 2016

So the "monitoring" claim is really just logging?  Good to know.  I do not have one but the way it was phrased led me to believe otherwise.

Marta Zanchi Health Technology Innovation

June 30th, 2016

I find this borderline acceptable. There is no such thing as "just marketing" when it comes to regulation - claims by manufacturers is precisely what FDA regulates, and a claim comes in the form of labeling, billboard advertisement, Facebook blog posts, etc etc... Surely, this post was written by someone who does not seem to be affiliated to Fitbit Inc. (the company), however if it is written in a Blog of an online community created and moderated by Fitbit Inc., the least I would expect is a comment by the moderator at Fitbit Inc that the device is not intended to be a medical device and these claims have not been reviewed by FDA.

Ken Steinberg Innovator and Serial Market Disrupter

June 30th, 2016

@Marta, it would probably be fine it they used the term "log" but monitor makes it seem like something altogether different. Until @Bob educated me, I too was taken aback.

Scott Elrod mHealth technologist☁ex-COO/CIO@Cloud 9-tech for behavioral health■ex-CIO@AmeriDoc(now Teladoc) healing 1.5M patients

June 30th, 2016

The FDA got pushback from wearable makers who wanted to opt-out vs medical device makers who wanted to opt-in.  In short, FDA regulated devices can have their data used by clinicians for medical judgments and get insurance reimbursement; data and cost from non-regulated wearables are to be used for broad non-clinical tracking and wide population health nudging.
Jan 2015 was when the line got drawn.  Ken - it sounds like you are still operating under the pre Jan 2015 mindset.   Here is how the language changed: http://mobihealthnews.com/39775/fda-clarifies-the-line-between-wellness-and-regulated-medical-devices

Ken Steinberg Innovator and Serial Market Disrupter

June 30th, 2016

@Scott, I will definitely give it a read.  My understanding, albeit might be wrong, was if the device is used for monitoring (at least in the glucose monitoring space) it is class 2. If the device is used for screening or diagnosis, it is Class 1.  All related to risk, and makes complete sense to me.  A bad glucose monitor can lead to poor insulin management which has long and protracted ramifications.

That beings said, I am anxious to further clarify the line in the sand as it defines potential to-market strategies and the capital required to achieve them.