The FDA doesn’t want to regulate wearables, and device makers want to keep it that way

The Food and Drug Administration doesn't want to take away your Fitbit.

That was the philosophy the FDA broadcast earlier this year when it unveiled its "draft guidance" for low-risk medical devices, a non-binding proposal that described the agency's thinking on regulation of devices like wearable fitness trackers. The guidance effectively suggests the agency won't vigorously regulate devices as long as they're not harmful and generally encourage healthy habits. Many devices with less-than-stellar track records for accuracy — such as calorie counters — would likely not be covered under the guidance. "Basically [we are] being transparent in where the FDA is focusing their enforcement efforts," says Bakul Patel, associate director for digital health at the FDA.

But the comments on the proposal, publicly released last week, show that some of the world's biggest tech industry groups and companies are pushing the FDA to make the lax regulations more explicit.

The draft guidance, "General Wellness: Policy for Low Risk Devices," describes which devices the agency believes it should focus on regulating. That includes "general wellness" products, which are described in two ways. First, the products that either have "an intended use that relates to maintaining or encouraging a general state of health or a healthy activity," such as a device that helps "log, track, or trend exercise activity." The devices may also have "an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions" when the science clearly shows a healthy lifestyle can have an impact. (The FDA already considers something a "medical device" if it's used to diagnose or treat a disease.) "Low risk" products, according to the guidance, are non-invasive and generally do not "pose a risk to a user’s safety if device controls are not applied."

The FDA is making the guidance at a time when the wearable tech is already a cycle years in the making. "The right time [to make the guidance] would've been five years ago," says Bradley Merrill Thompson, a member of the firm at Epstein Becker & Green who focuses on medical device regulation. Android Wear and the Apple Watch are already here, adding features constantly. The agency has already recommended letting some medical apps go to market without regulatory supervision, and the new guidance is arguably just an extension of that fact. But as the scope of medical devices has increased, device makers have asked the FDA to define exactly where the regulatory line is.

Samsung, which produces wearables like the Gear family of devices, has asked the FDAfor explicit mentions of some types of products — and has even gone so far as to suggest the language the agency should use in its final guidance. The company wants to make sure the FDA won't regulate some devices that store data, such as an app that stores blood glucose or blood pressure data from another device. The company's suggested addition is this: "Product X promotes physical activity, which, as part of a healthy lifestyle, may help reduce the risk of high blood pressure. If Product X also includes [a Medical Device Data System] feature for tracking and displaying blood pressure data that is generated by a connected medical device, this will not disqualify Product X from being considered a wellness product."

Similarly, the Telecommunications Industry Association, which represents hundreds of companies, suggested the FDA include references to a "mobile medical application" that would store blood pressure and glucose information, whether inputted by the user or wirelessly sent to an app.

And the Consumer Electronics Association, the massive trade organization behind CES, said in its comments that it wants certain specific examples included in the guidance. The CEA suggests a wearable device for tracking mood — a product "similar to a ‘mood ring,'" according to the filing, an idea that has resulted in scientifically dubious products before — should be included as a "general wellness" product under the guidance. But it doesn't just end at mood trackers — other devices that the CEA suggests should be considered general wellness products include those that promote a healthy diet by tracking or reducing the amounts people eat of things like sodium or sugar; those devices meant to help people avoid unhealthy behavior, like devices that support smoking cessation; and devices meant to prevent injury.

The FDA, then, is working a balancing act: craft a policy detailed enough to offer guidance, but broad enough to give itself latitude. "It's hard to put in that precision without putting handcuffs on yourself," Thompson says. Although it's clear some devices would still be regulated — the FDA cites products like computer games that claim to treat autism, or other products that claim to treat anxiety — the device makers, it seems, want the line as bright as a mood ring.

The agency is working on the final version of the guidance, but hasn't laid out a timeframe for when it will be completed, although device makers are pushing for it to happen soon. In the meantime, the tech industry has made it clear that they believe regulation, in the CEA's words, shouldn't stop consumers from having the ability to "self-manage" their health. "We recognize and support FDA's authority to regulate medical devices," the CEA writes in its comment, "but believe that consumers should have access to low risk technology that will enable them to live a healthier lifestyle."