The FDA wants to regulate your connected toothbrush

Alex Frommeyer, the CEO of a company making connected toothbrushes, ended February thinking he was about to launch his Bluetooth-enabled brush in the following month. But the Food and Drug Administration had different plans. In March, the month the brush was supposed to launch, the FDA called him up and said that it needed to approve the product.
Today, roughly four months after the FDA intervened, Beam Technologies scored the FDA’s approval to market its Beam Toothbrush, and Frommeyer is happy to report that the brush should now arrive in retail stores and online in October. But the backstory of this approval is one that many startups seeking to add connectivity to medical devices — or maybe even medical apps to regular smartphones — should read.
As more startups seek to enter the medical IT space with connected devices, apps or new services, the looming threat of the FDA’s famously lengthy approval process is something most want to avoid. Corey Ackerman, president of Happtique, once shared an anecdote with me about a doctor who got approval for a medical app that was certified on an early version of the Android operating system only to realize that technically upgrading the app to later OSes would void the approval. But the FDA is aware of the ecosystem that’s seeking to connect medicine and tech and last year even pulled together a report trying to figure out how it should be regulated.

But the agency is not waiting around to figure out its strategy, based on Frommeyer’s experience. The FDA is aggressively arguing that adding connectivity and/or sensors to a medical device changes into a new class of device that needs FDA approval.
In February Frommeyer went public with his plans to build and market a toothbrush that used a Bluetooth radio and sensors to connect the toothbrush to a smartphone app that would track how long someone brushed and also offer music and entertainment while brushing. At the time, he told me one of the reasons he chose to build a connected toothbrush was that he didn’t need FDA approval, he only needed to submit the brush’s design. He told me:

On a practical side, dentistry is an easier entry point into the medical field because the Food and Drug Administration has more lenient rules for approving toothbrushes. They are medical devices, but as long as someone submits the design to the FDA, he can sell it. That means Beam can sell its toothbrush without spending millions and waiting for FDA approval.

However, the FDA disagreed and in March, called Frommeyer up and argued that because the connected toothbrush was essentially a new class of toothbrush (which the FDA classifies as a medical device) it would require the agency’s approval. Frommeyer didn’t like it, but he didn’t have much choice in the matter. “I thought their argument was weak, but what could I do,” he said. Thankfully the FDA worked quickly, got the documentation around connected toothbrushes that it needed and today Frommeyer got his approval.
That means the Beam toothbrush will hit the market in October with a retail price of $50 for the base and $4 for the replacement head. Folks who want a discount can visit the web site and pre-oder the base for $35 if they’re so inclined.
So perhaps the next frontier in the quantified self will involve dental data. Although personally I’m more excited about using it to help my five-year-old daughter get excited about spending the full two minutes brushing her teeth and seeing that she’s doing so using the data, instead of standing over her shoulder and nagging her.