FDA Clarifies Medical Device Rules

As new consumer hardware and software capabilities have collided with medicine in recent years, consumers and manufacturers have struggled to identify the line between “wellness” products such as headphones that can also amplify and clarify the voices of surrounding speakers and regulated medical devices such as conventional hearing aids. On January 6, 2026, the U.S. Food and Drug Administration released new guidance documents clarifying how it interprets existing law for the review of wearable and AI-assisted devices.

The first document, relating to general wellness, specifies that the FDA will interpret non-invasive sensors such as sleep trackers or heart rate monitors as low-risk wellness devices while treating invasive devices under conventional regulations. The other document defines how the FDA will exempt clinical decision support tools from medical device regulations, limiting such software to analyzing existing data rather than extracting data from sensors, and requiring them to allow independent review of their recommendations. The documents do not rewrite any law, but they refine the interpretation of existing law, compared to the 2019 and 2022 documents they replace. They offer a new look at how regulators view technologies that sit at the intersection of consumer electronics, software and medicine – a category that many other countries choose to regulate more strictly rather than less.

What Update 2026 Changed

The FDA’s 2026 update clarifies how it distinguishes between “medical information” and systems that measure physiological “signals” or “patterns.” Previous guidance addressed these concepts more generally, but the new version defines signal measurement systems as those that collect continuous, near-continuous, or continuous data from the body for medical purposes, such as home devices transmitting blood pressure, oxygen saturation, or heart rate to clinicians. He gives more concrete examples, such as a blood sugar lab result as medical information versus continuous readings from a glucometer as signals or patterns.

The updated guidance also clarifies examples of what constitutes medical information that software can display, analyze, or print. These include radiology reports or summaries from legally marketed software, ECG reports annotated by clinicians, blood pressure results from authorized devices, and laboratory results stored in electronic health records.

Additionally, the 2026 update softens the FDA’s previous stance on clinical decision tools that offer only a single recommendation. While previous guidance suggested tools needed to present multiple options to avoid regulation, the FDA now indicates that a single recommendation may be acceptable if only one option is clinically appropriate, although it does not define how this determination will be made.

Additionally, updates to the general wellness guidelines clarify that certain non-invasive wearable devices, such as optical sensors that estimate blood glucose levels for wellness or nutrition awareness purposes, may be considered general wellness products, whereas more invasive technologies would not.

Well-being still requires precision

For designers of wearable health devices, the practical implications extend far beyond label choice. “Calling something ‘wellness’ doesn’t reduce the need for rigorous validation,” says Omer Inan, a medical device technology researcher at the Georgia Tech School of Electrical and Computer Engineering. A wearable device that reports blood pressure inaccurately could lead a user to conclude that their values ​​are normal when they are not, which could influence decisions about seeking clinical care.

“In my opinion, engineers who design devices intended to provide health and wellness information to consumers should not change their approach based on these new guidelines,” says Inan. Some measurements, like blood pressure or glucose, have real medical consequences, regardless of how they are marked, Inan notes.

Unless engineers follow robust validation protocols for technology providing health and wellness information, Inan says, consumers and clinicians face the risk of misinformation.

To solve this problem, Inan advocates transparency: companies should publish their validation results in peer-reviewed journals, and independent third parties without financial ties to the manufacturer should evaluate these systems. He says this approach helps the engineering community and the general public evaluate the accuracy and reliability of wearable devices.

When well-being meets medicine

The societal and clinical impacts of wearables are already visible, regardless of regulatory labels, says Sharona Hoffman, JD, professor of law and bioethics at Case Western Reserve University.

Medical measurements from devices like the Apple Watch or Fitbit may qualify as “wellbeing,” but in practice, many users treat them as medical data, influencing their behavior or care decisions, Hoffman points out.

“This could cause anxiety in patients who are constantly checking their parameters,” she notes. Alternatively, “a person may walk into a doctor’s office confident that their wearable device has diagnosed their condition, complicating clinical conversations and decision-making.” »

Additionally, privacy concerns remain unresolved and unmentioned in previous or updated guidance documents. Many companies that build wellness devices don’t have protections like the Health Insurance Portability and Accountability Act (HIPAA), meaning data on health metrics could be collected, shared, or sold without the same constraints as traditional medical data. “We don’t know what they’re collecting information on or whether marketers will get it,” Hoffman says.

International approaches

The European Union’s artificial intelligence law designates systems that process health-related data or influence clinical decisions as “high risk,” subjecting them to strict requirements for data governance, transparency and human oversight. China and South Korea have also implemented rules that tighten controls on algorithmic systems that intersect with healthcare or public-facing use cases. South Korea offers very specific regulatory categories for technology manufacturers, such as standards on the labeling and description of medical devices and good manufacturing practices.

In these regions, regulators classify technology not only based on its intended use, but also based on its potential impact on individuals and society as a whole.

“Other countries that emphasize technology still worry about data and patient privacy,” Hoffman says. “We’re going in the opposite direction.”

Post-market surveillance

“Whether or not something is approved by the FDA, these technologies will need to be monitored in the sites where they are used,” says Todd R. Johnson, professor of biomedical informatics at the McWilliams School of Biomedical Informatics at UTHealth Houston, who has worked on FDA-regulated products and informatics in clinical settings. “There is no way policymakers can guarantee in advance that all recommendations will be sound.”

Large health systems may have the capacity to audit and monitor tools, but smaller clinics often do not. Monitoring and auditing are not emphasized in the current guidelines, raising questions about how reliability and security will be maintained once devices and software are deployed at scale.

Reconciling innovation and security

For engineers and developers, the FDA’s 2026 guidance presents both opportunities and responsibilities. By clarifying what constitutes a regulated device, the agency could reduce initial hurdles for certain categories of technology. But this change also places more importance on design rigor, validation transparency and post-market monitoring.

“Device manufacturers care about security,” Johnson says. “But regulation can increase barriers to entry while increasing safety and accuracy. There is a trade-off.”