The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general wellness category and skip the agency's expensive review process before going to market.
The changes build on the Department of Health and Human Services’ (HHS) Make America Healthy Again agenda and its recent efforts to open up regulatory pathways for health technology to assist in the treatment of chronic diseases.
FDA Commissioner Marty Makary, M.D., made the announcement during a session at the Consumer Technology Association’s CES conference in Vegas. The agency updated two guidance documents that clarify how it defines general wellness devices and clinical decision support software (CDS), which bears a higher regulatory burden because it is expressly intended to help clinicians make decisions.
FDA added new sections and examples clarifying the rules for “non-invasive” devices that collect and analyze physiologic data, according to a law firm’s red-line analysis of the new guidance document.
FDA clarifies that non-invasive products that estimate blood pressure, oxygen saturation, blood glucose and heart rate variability could be considered wellness devices, rather than regulated as medical-grade devices, so long as they meet its definition of low risk.
This category includes wearables such as smartwatches, smart rings, patches, and other sensor-based technologies that are used to promote general wellness. They often track things like heart rate during workouts or sleep, or allow users to count caloric intake.
Also falling into the general wellness category, FDA says, are blood glucose monitors used to assess nutritional choices, not manage diabetes, or devices for elite athletes that measure electrolyte balance and hemoglobin. FDA added these examples to the updated document in its most recent update.
“We have a clear lane for medical-grade products, but otherwise, we need to adapt with the times and be proactive with guidance so that companies and developers are not left confused about what they should be doing or what the FDA wants,” Makary said in a video posted on X.
Devices can qualify as general wellness devices so long as they don’t claim to treat or prevent a specific disease, do not include specific guides for clinical action, and do not use values that mimic clinically-validated values.
The FDA has previously published guidance differentiating general wellness devices and CDS, but the last updates were made in 2019 and 2022, respectively. Technology has advanced considerably in the last four to six years, Rene Quashie, vice president of digital health at the Consumer Technology Association, said in an interview.
“We've got wearables companies that are members … and they've long expressed not just regulatory red tape, but the confusion between medical and wellness and where that line should be drawn, and that's been the issue,” Quashie said. “I think what we heard yesterday from the Commissioner, I think clarifies that line significantly. And so I think a lot of wearables companies are going to be happy at the clarity. And I think overall, what you're going to see in the next two years is a slew of innovative tools that are developed and brought to market on the wellness side of the wearable.”
In July 2025, consumer wearable company WHOOP received a warning letter from the FDA stating that its Blood Pressure Insights crossed the line from a wellness device to a medical device. Brian Scarpelli, executive director of the Connected Health Initiative and Nate Beaver, a lawyer at Foley and Lardner, said they believed the new guidance was related to the WHOOP letter.
The FDA did not allow for a public comment period on the guidance documents, though stakeholders can provide feedback through the FDA website. Quashie said that despite the lack of a public comment period, he feels the agency has been engaging often with health tech companies, advocacy groups and associations—even more than past administrations.
Makary said on Fox News that the guidance will provide predictability for markets and investors.
“The @US_FDA is unlocking wearable devices for general wellness that have, for too long, been tied up in red tape,” Health Secretary Robert F. Kennedy Jr. wrote on X. “Wearables can help everyday Americans proactively take charge of their health, helping them steer clear of expensive interventions and chronic disease. Thank you, @DrMakaryFDA, for your leadership.”
Several sources agreed that the changes to the general wellness document are more significant than the changes made to CDS guidelines. However, the changes are still regarded as clearing up the gray area for the industry.
The CDS guidance now clarifies that the agency will use enforcement discretion for devices that meet all exemption criteria, but fail the criteria that stipulates the device cannot make just one recommendation.
FDA’s previous reasoning was that if a device made multiple recommendations, a clinician could use their judgment to select the best path forward. If it only offered one, it would more clearly sway the clinician’s decision, the previous reasoning said.
Now, the FDA is offering regulatory relief in cases where software only makes one recommendation, in cases where only one recommendation is clinically relevant.
“I think what the FDA is responding to is technological developments and unleashing the power of CDS to help hospitals and providers better treat patients,” Quashie said.