FDA Medical Device Question: Can you have it both ways?

Gerry DeSeve President, Climateon

January 20th, 2016

When doing customer research and sharing my wearable tech product concept with people, I'm often asked if it could be used to treat hot flashes. I've always said no - it is designed to improve building energy efficiency and so no medical claims are being made for it.

But today I came across the "ambi" device which has a page devoted to hot flashes (http://myambi.com/en/content/2-hot-flashes). So, to me, it seems like ambi is a medical device and would need to go through the 510(k) process. But the manufacturer also says "The benefits of ambi(TM) have not been evaluated by the US FDA or other regulatory authority. ambi(TM) makes no medical claims to treat, cure or prevent any disease or medical condition."

Can you really have it both ways like this: marketing like a medical device but not going through the FDA 510(k) process? Is this really not a medical device at all? Or are they skating on thin ice by talking about hot flashes and then slipping in this disclaimer?

I'd love to get an answer so I can be sure I'm not missing a market opportunity.

Jared Seehafer Product and Business Strategist

January 20th, 2016

Gerry, Developing something that is used as a medical device without going through regulatory approval is generally a dangerous game. There are a couple of startups doing things much more invasive and novel than this product and I think they're going to get a rude awakening if they get big enough to draw attention. In the case of this product, however, there is precedent for them not needing FDA clearance. FDA has a fairly comprehensive listing of how it views different types of devices. The closest thing I could find to this either Powered Heating Pad (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=4795) or Water Circulating Cold Pack (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=4700). Both of these devices are what’s known as 510(k) Exempt, in that the FDA has decided that ordinarily they would require a 510(k) before marketing but because there’s so much history with this technology they’ve decided to make them exempt from submission. So it comes down to, how does this ambi device actually work, and is it close enough to existing devices (FDA’s term for this ‘substantial equivalence’) that you can make an affirmative case that they’re really no different than what FDA has seen before, and FDA has decided in this particular case that’s what come before is so low risk they don’t need to see a submission. If the makers of this product have come to that determination, then their disclaimer isn’t a sign that they’re flying under the radar and haven’t been caught yet. Rather it’s a simple legal truism: no regulatory agency has seen this product, so they can’t claim otherwise. And any attorney with experience in health technology would advise you to state that up front in your labeling if it’s true. Hope that helps. Feel free to reach out to me if you have questions about your product. Jared Seehafer -- Jared Seehafer http://seehafer.net tel: 661-414-2081

Kimberly Langdon M. D.

January 21st, 2016

Hi Everyone, The claim that Ambi makes is well know to physiologists since it is a fact that cold applied to the surface of the skin results in nerve signals to the hypothalamus. I think they are using it as a marketing tool to make it sound more scientific. But, in fact, any cold pack or cold producing apparatus could use the same explanation and be right. Likewise, the fact that cold reduces swelling, itching, inflammation, and pain has been well know for decades, perhaps centuries. This is no different. The FDA should be focused on concepts or devices whose mechanisms of action are unknown or poorly understood. Submitting the Ambi to the FDA process would be a colossal waste of time and resources, in my opinion. Thanks, Kim

Gerry DeSeve President, Climateon

January 20th, 2016

Jared,

Thanks for your excellent answer - I really appreciate it. The ambi doesn't fall into any exempt category that I've found: it isn't a heating pad (it only does cooling) and it is solid state (no water circulation). There is no exempt category for electric cooling that is equivalent to the heating pad, unless you can argue (as many engineers would) that cold is just the absence of heat...

Most substantially equivalent technology is either water-circulating or uses a non-electronic cooling medium, like an ice pack.

It looks like they are flying below the radar...

Thanks again!

David Maltz Strategic advisor and consultant for medical device and digital health development & innovation

January 21st, 2016

It's important to remember that what the FDA is really regulating is the claims one makes, and ambi's statement that it "triggers a response from the hypothalamus ... which stops or reduces, within seconds, the effects of a hot flash and ensuing sweats" and will "quickly and naturally stop the flash" is straying into a medical claim, in my view.

Jared's point about a 510(k) exempt status is a good one - I led engineering for a couple of years at a firm working on such a product (gameready.com). Being 510(k) exempt doesn't mean that you're exempt from having data to back up your claims, just that you don't have to have submitted it to the FDA prior to placing it on the market. Most importantly, however, is that if you're planning on marketing a medical device, you have to have in place a functioning Quality Management System with design controls, CAPA, a complaint system, etc. A lot of this is really just good practice as a way to run a high-quality product development business, so it doesn't have to be seen as a lot of overhead, but it's definitely one the "nice to have" side of things if you're running a lean startup and don't have medical ambitions.

Gerry DeSeve President, Climateon

January 21st, 2016

Dr. Langdon, Jean-Luc & Michael, thank you all for your input - this has been tremendously helpful. My takeaway is that the risk/reward for touching on possible medical-like uses is not in favor of my company at this point. It is a tangential market at best, and sorting this out, testing and marketing to the target customers would require more resources than are available at this point - especially if a device like the ambi already exists...

Thanks again your time.

All the best,

Gerry DeSeve

Jean-Luc Vanderheyden Consulting for drug and imaging agents from Discovery and Development to Commercialization

January 20th, 2016

I agree with Jared and Michael to some extent. Here is the link from the FDA on device classification: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/

Going further, you can find a hot/cold bottle under general hospital for example as a Class I. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=880.6085

Finally, if this was going to be for different markets than the USA, it is even more complicated. Green light-Guru does a good description of what to consider: http://blog.greenlight.guru/medical-device-regulatory-classification

All the best,

Jean-Luc

Kimberly Langdon M. D.

January 21st, 2016

As an Ob/gyn, I would be surprised if women would pay $49.99 for what is basically a cold pack. Since there are no medical claims except cooling someone who gets hot, I see no problem not calling this a medical device. Do we call fans medical devices?

Michael Barnathan

January 20th, 2016

Oh, also note that 510(k) and the full premarket approval are two separate processes, and I've seen many who have demonstrated equivalence to a predicate continue to slip that disclaimer in.

Michael Barnathan

January 20th, 2016

This depends on the class of the device - if class 2 or 3, a 510(k) is necessary. Some startups either don't know the regulations or figure they'll just ask for apology later - while a dangerous game, it may be less dangerous than holding everything up on the process. I've had a startup fail because I was too willing to play by the FDA's rules instead of simply going to market and throwing caution to the wind.