Four Ways to Connect to The Health Market While Reducing or Avoiding FDA Requirements
Before I go through the four strategies, it probably goes without saying that each one is predicated on the company fully implementing the strategy in good faith. Anything less potentially becomes FDA law evasion, rather than avoidance. Okay, so here they are:
Strategy 1: avoid medical devices and their accessories. About now you’re wondering whether this article is worth reading, but stick with me for a second, there’s a more subtle and profound observation to be made. In your mind, go back to the very first article on the scope of FDA regulation. I went through an example of a stick, and how it could be either a popsicle stick or a pediatric tongue depressor, depending on what claims the company chooses to make. My point is that in many cases, the design of the product does not determine its regulatory status, but rather the promotional claims determine its status. So if your company can reach its commercial objectives without medical claims, and if the product has legitimate and material nonmedical uses, you might be able to avoid FDA regulation by avoiding medical claims.
A simple cell phone provides another example. A cell phone can be promoted merely as a cell phone, and no FDA compliance issues will arise. But if the manufacturer of the cell phone starts to make claims that the phone is suitable specifically for healthcare applications, the cell phone manufacturer runs the very real risk of turning its simple phone into a regulated medical device.
Remember from the first article that the manufacturer might get into trouble making claims that its product is specifically intended to accompany a medical device. That may very well make the product an accessory to the medical device, which makes it a regulated device. Again, claims are pivotal in determining whether something is an accessory or not.
In the last couple years as I’ve been watching what’s coming out of Silicon Valley, I’m seeing a tremendous number of hardware and software products that probably could be sold as unregulated articles, but where the manufacturer, possibly quite inadvertently, is making claims that would cause FDA to regulate them. FDA is stretched pretty thin these days, so they aren’t watching everything coming out of the IT industry, but someday I suspect FDA will get more active in this space.
There are limits to this strategy. I can’t make a pacemaker, for example, and try to pass it off as a simple, generic piece of electrical equipment. In designing the pacemaker, I’ve done too much to make the design specific to a medical use to later disclaim that use. Remember intended use is judged by words, actions, and in some cases, inaction. If you’re interested in this strategy, you ought to review the first article in this series.
A number of startups in mHealth have come up with very innovative business plans that put them squarely in the gray area between medical and nonmedical intended uses. For example, there are companies developing strategies for remote monitoring of people, rather than their disease or condition. There are gray areas between wellness programs and disease programs where FDA needs to give industry clearer guidance. Obesity, as a disease, is often difficult to distinguish from general physical conditioning. Unfortunately, I suspect we will all need to feel our way along in the dark for the time being.
Finally, to employ this strategy, the maker of the equipment must be duly diligent in avoiding making medical claims. That means it needs to have some level of compliance and training systems in place to ensure, for example, that sales representatives do not go rogue. Even unauthorized sales activity can come back to haunt the company if the government decides that the company wasn’t careful enough in managing its people.
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