By Paul A. Jones and Joel E. Henry, Ph.D. (Managing Partner, Michael Best’s Missoula Office)
So when is a consumer product – say a little matchbook-sized box you wear on your wrist that keeps track of your pulse over the course of the day -a medical device?
"What difference does it make?" you might ask. Well, if you are developing that little box for market, quite possibly tens of millions of dollars of added development and testing expenses, a couple of years more development and testing time, and millions of dollars of legal fees, regulatory expenses, insurance premiums, and misc. other costs both before market introduction and after. Not to mention likely a different distribution model, a higher price point, and lower volumes.
Alas, having perused FDA Guidance on distinguishing consumer products from medical devices (including some recent draft Guidance), and talking about the matter with some of my colleagues who spend substantial time practicing in the medical device regulation space, my take is that there is a lot of gray area around this question. Which is to say, there are a lot of current and soon-to-appear products out there for which good arguments could be made that they are consumer products - and good arguments could be made that they are medical devices. And that in some cases, the answer might even hinge on whether the manufacturer labels the product a toy. And that's a problem.
While it takes pages and pages of regulation and guidance to get there, basically the distinction between a consumer product and a medical device - according to the FDA, which is to say the people that matter here - is pretty simple: the application of the distinction, less so.
First, the distinction. If the purpose of a product is to process inputs which are collected by the product from a person (a substance, for example sweat or blood, or data, for example a pulse) and use that to diagnose or suggest treatment for a medical condition, you have a medical device. Thus, for example, a personal ECG consumers can purchase without a prescription for the purpose of determining if they should see a doctor about an arrhythmia is a medical device, and is regulated as such. And that is true regardless of the intended use (well, I think so: more later).
Now, on the above logic, you would think that a product you wear on your wrist that keeps track of your pulse would be a medical device. I mean, the only real reason to have such a device - beyond a gee whiz sort of curiosity - is to monitor your physical activity for purposes of improving (or at least monitoring) your health. Clearly a medical device, right?
Well, no. The FDA has said, in its guidance on medical devices, that it will not deem a product a medical device if it's only intended use is to encourage or maintain a general state of health or healthy activity, and the use of the product does not entail any significant risk to the user or third parties. Thus, your smartphone app for keeping track of your pulse isn't in fact a medical device according to the FDA. This class of products would include (among many others) things that monitor calories burned or suggest healthy menus to control weight.
On the other hand, if your exercise monitor claims it can help you manage your Type II Diabetes, you've got something that is a medical device and that the FDA will consider to be a medical device. (You can see, I think, how this could get confusing.)
It gets more confusing. Our exercise monitor that is marketed as a tool for helping manage Type II Diabetes is in fact a medical device according to the FDA, and thus subject to regulation as such by the FDA. But the FDA, as a matter of policy, has indicated that it will not enforce those regulations with respect to such a medical device. That's not a regulation but a policy. Which means it can be changed pretty much any time for pretty much any reason, without going through any rule making process or seeking industry or consumer input.
The thinking, here, is not to enforce the medical device regulations in the case of medical devices that present a low risk and are aimed at helping the consumer better manage a particular medical condition where the use of the device conforms to a generally accepted medical consensus. In this case, getting more exercise is a generally accepted mechanism for managing Type II diabetes. Another example of this kind of medical device would be a device that "coaches breathing techniques and relaxation skills, which, as part of a healthy lifestyle, may help living well with migraine headaches." But, then again, FDA guidance says that it would regulate a medical device that listened to someone's breathing to diagnose bronchitis (and yes, there is technology that does just that).
You can see, I think, how all of this can get pretty confusing. And we have not even talked about what "low risk" means (basically, if a product is invasive - that is it involves puncturing the skin or otherwise inserting something in the body as opposed to on it, or if it involves applying something (a laser, for example) to the body that could harm the user or a third party if not used correctly, you have a product that is not low risk).
If you think you can figure all this out on your own, here is a final twist; admittedly a pretty strange twist, but I think a valid one for purposes of illustrating how much uncertainty there is as the FDA struggles to adapt to a rapidly changing technological environment.
If you've ever had kids, you know that you can buy toy stethoscopes. These products, at least some of which are as functional as low end "real" stethoscopes, are not regulated as medical devices. They are marketed and intended to be used as toys, and include labels that they are not to be used for medical purposes.
On the other hand, traditional stethoscopes intended for medical use are medical devices (albeit regulated with a light touch). And "smart" stethoscopes - devices that enhance, manipulate, or interpret information generated by the stethoscope - are in fact regulated as medical devices (which, given the initial example of the personal ECG product, isn't surprising).
So, what about a "toy" smart stethoscope? Before you say that labeling it a toy doesn't work because it is clearly capable of performing a medical function, remember that so can a dumb toy stethoscope.
The answer? I am not sure. But there is, in fact, a "business card toy ECG" on the market. At least there is as this blog goes to press. You figure it out. And if you are smart, talk to your lawyer about your thinking before you run too far with it.