FDA Eases Wellness Device Regulation, But Marketing Is Still Key

The Food and Drug Administration’s decision to ease oversight of general wellness devices and certain artificial intelligence-driven software is designed to accelerate innovation and provide predictability for developers.

But it also redraws a critical regulatory boundary. Many products that collect and analyze sensitive biometric data will now fall outside FDA review as long as they avoid explicit medical claims.

Legal, regulatory, and marketing teams for wellness device manufacturers will still need to ensure health trackers and wearables are accurately represented in their consumer-facing materials.

Smartwatches, Fitness Trackers

We’ve come a long way from stethoscopes and clip-on pedometers. Smartwatches, fitness trackers, smart rings—even continuous glucose monitors—are now part of everyday life.

Tracking health through biometrics has never been easier, yet the legal and ethical lines have never been blurrier.

It’s one thing to see how your body performs during an intense workout, but is reviewing that heart-rate data actually helping you manage high blood pressure? Does a nightly meditation app treat insomnia? Can a smart ring really help treat anxiety?

Updated Guidance

To clarify the distinctions between regulated medical devices and general wellness products, the FDA recently released updated guidance on the topic. That distinction matters, because products classified as medical devices are subject to significantly more regulatory oversight than general wellness products.

Thankfully, the guidance is clear: General wellness products “(1) are intended for only general wellness use, as defined in this guidance, and (2) present a low risk to the safety of users and other persons.”

The guidance identifies two categories of products intended for general wellness use. One is products with an intended use related to maintaining or encouraging a general state of health or healthy activity. The other includes products with an intended use related to the role of a healthy lifestyle in helping reduce the risk or impact of certain chronic diseases or conditions, where it is well understood and accepted that healthy lifestyle choices play an important role in health outcomes.

Put simply, general wellness devices promote healthy habits and lifestyle choices without claiming to treat or manage a specific medical condition. A smartwatch that nudges you to take a short walk after a long period of sitting fits this category; one that claims to help treat type 2 diabetes doesn’t.

Why the Change?

In a recent social media post on the subject, FDA Commissioner Marty Makary commented that this new guidance aims to “cut unnecessary regulation and promote innovation to keep America first.”

But practitioners note that this updated guidance directly contradicts the agency’s warning letter to WHOOP, a watch-like wearable, where it claimed that the blood pressure tracking feature on the device pushed the wearable over into the medical device category, as blood pressure readings are “inherently associated with the diagnosis of hypo- and hypertension.”

This inconsistency raises questions about how the FDA will apply the guidance in practice, and how wearable companies will be able to rely on it going forward.

What This Means

Marketing materials will take on new significance. Because products are classified based on their health and clinical claims—rather than the nature of the data collected—legal, regulatory, and marketing teams will need to work together closely to ensure the health trackers and wearables are accurately represented in their consumer-facing materials.

Claims associated with the effectiveness and intended use of wearables will need to be re-evaluated to avoid crossing over into the medical device category—in addition to triggering false claims, Federal Trade Commission, or state law concerns.

Other Laws

For wellness devices outside the realm of medical devices, privacy and data governance just got tougher. Products outside the scope of the FDA’s medical device rules don’t exist in a vacuum: They become subject to a variety of other frameworks and state laws, including the FTC’s laws against unfair or deceptive marketing claims, state consumer protection laws, product liability, and federal and state healthcare privacy laws.

In addition, the collection of biometric information (found in wearables and other technologies) has been a hot-button issue, with states such as Illinois, Texas, and Washington creating standalone laws to explicitly protect biometric data collected by private-sector companies.

These laws aren’t enforced by a single regulator but by state attorneys general, consumer protection agencies, local courts, and, in some cases, private litigants—making the risk landscape for general wellness products fragmented and unpredictable.

Future Developments

As wearables continue to grow in popularity, the FDA’s updated guidance doesn’t eliminate all legal responsibilities for general wellness products. Rather, it ensures that products are appropriately positioned in the market while staying away from unsupported and out-of-place medical claims.

Companies seeking to stay in the general wellness classification must continue avoiding claims that their product helps treat or mitigate any specific medical conditions. Those that do make such claims should be prepared for FDA oversight.

Regulatory classification will depend less on the types of data collected and more on what the company claims that data can do for users.

This article does not necessarily reflect the opinion of Bloomberg Industry Group, Inc., the publisher of Bloomberg Law, Bloomberg Tax, and Bloomberg Government, or its owners.

Author Information

Alexandra Sumner is chief privacy officer and corporate counsel for Microhealth, an international medical device company.

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