FDA updated its General Wellness policy to clarify and take a step back from previous positions on health and wellness technology.
The Food and Drug Administration (“FDA”) unexpectedly updated its policy on general wellness products on January 6, loosening some constraints and signaling a shift in how the agency approaches wearable health tech. In the process, FDA took a step back from its position it announced in a July 2025 warning letter to the wearable technology company WHOOP over its “Blood Pressure Insights” feature.[1]
FDA’s Regulation of Wearable Tech
Over the last decade, wearable health tech has evolved via the regulatory environmental pressures created by an FDA guidance titled General Wellness: Policy for Low Risk Devices (“General Wellness Guidance” or “Guidance”).[2] This Guidance explained FDA’s quasi-interpretive/quasi-enforcement discretion policy that exempts from FDA review products that are “low risk” and meet the definition of “general wellness products.” Low risk products are those that are not implanted, do not pierce the skin, and do not otherwise pose a safety risk to users or others (e.g., lasers or radiation exposure). General wellness products are products intended only for general wellness use that either (1) do not make any references to diseases or conditions, or (2) if they do reference diseases or conditions, they do so as means to promote a healthy lifestyle for reducing the risk of, or to help live with, the disease.[3] For example, a sleep tracking feature that uses optical sensors and accelerometers to advise on sleep quality is not regulated by FDA. But, a feature using the same sensors and data to detect and identify signs of sleep apnea is regulated. Why? While both are “low risk,” sleep apnea is a disease and the feature is intended to diagnose it, as opposed to advise on reducing the risk of developing it or helping to live with it.
Throughout the last decade, this policy has steered product development for wearable tech companies, helping them make the choice of whether it was worth the time and money to seek FDA clearance or whether it is better to limit the feature for general wellness purposes and avoid FDA regulation. But the Guidance was also subject to criticism that it was too conservative and that the tech offered by wearables does not fit neatly into the in-or-out jurisdictional scheme. For example, the CEO of Oura Ring recently called on Congress to clarify FDA’s jurisdiction over wearables by creating a new regulatory scheme for products that warn but do not diagnose.[4]
WHOOP Steps into the Void
In July 2025, FDA issued a warning letter to WHOOP regarding its “Blood Pressure Insights” feature that provided daily systolic and diastolic blood pressure estimations that WHOOP described as intended for understanding how blood pressure affects performance and well-being. WHOOP also described their health insights as “medical grade” and its website stated that “higher blood pressure may be an indicator of poor sleep.” FDA warned that the measurement or estimation of a user’s blood pressure is inherently associated with the diagnosis of hypo- and hypertension (i.e., high blood pressure), and is therefore intended to diagnose a disease.[5] FDA also cited the reference to “medical grade” and “high blood pressure” as evidence that the feature was marketed to diagnose disease.
But WHOOP pushed back against FDA’s interpretation. WHOOP stated that its blood pressure feature was designed to help users “understand how blood pressure relates to sleep, stress, recovery, and exercise.”[6] Since July 2025, FDA and WHOOP have been in a standoff. WHOOPs Blood Pressure Insights claims remained on their website. The FDA’s warning letter to WHOOP remained on theirs.
FDA Broadens the General Wellness Exception
On January 6, FDA Commissioner Marty Makary went on Fox Business News and reported on the release of the new Guidance that “lets companies know that if their device or software is simply providing information, then they can do that without FDA regulation.”[7] He added that “the only stipulation is if they make claims of being medical grade.” While that seems clear and easy to follow, and it is a good indicator of the Commissioner’s intent in pushing out the update, that is not what the new language says.
The new language makes it clear that that data derived from blood pressure or other physiological parameters can be provided to a user without causing the feature to be a regulated medical device, so long as they are not intended for medical or clinical purposes, but rather for health and wellness purposes.[8] The Guidance also clarifies that the feature should not prompt or guide specific clinical action or medical management based on the health information. While this is clarifying, it is also not much different from the previous version of the Guidance. Features should still avoid implying that they can be used to diagnose, mitigate, or treat disease.
So, does this mean WHOOP’s blood pressure feature is actually a general wellness product? No, because of WHOOP’s claim that the product offers medical grade insight; something the Guidance and the Commissioner say causes a product to be a medical device subject to regulation. Also, WHOOP may have to take down their reference to high blood pressure and should ensure that the feature does not prompt or guide specific clinical action (which, as an aside, is an area ripe for ambiguity). But assuming they cure these issues, can they provide daily diastolic and systolic measurements to users? Yes. Example seven of the Guidance, which is newly added, suggests that it can so long as it is in a health and wellness context and does not mention disease, but with the confusing caveat that those ranges are validated.[9][10]
Where Do Wearable Tech Companies Take This?
The Guidance gives wearable tech more clarity on the types of claims it can make. Going forward, FDA is unlikely to try again to take action against a feature that describes a physiological measurement based solely on that measurement being an indicator for an unstated disease. The Guidance explains that some of the ways that companies can avoid disease claims is by being clear that the device is not intended to diagnose disease, that the product does not substitute for FDA-cleared products (such as claims of clinical equivalence, clinical accuracy, or medical or clinical grade), and the product does not prompt or guide specific clinical action or medical management based on the blood pressure data. But otherwise, not much has changed and there still is a blurry line between regulated and unregulated.
Take, for example, features that monitor for atrial fibrillation (“AFib”). Apple Watch, Fitbit, Garmin, and Samsung Galaxy Watch each have FDA clearance to market electrocardiogram (“ECG”) technology that is intended to “determine the presence of AFib” or “identify episodes of irregular heart rhythms suggestive of AFib.” [11] WHOOP markets, without FDA clearance, a similar ECG product intended to “detect potential signs of AFib.” [12] Is “identifying signs of” any different than “identifying episodes suggestive of” with respect to a user’s understanding of whether they have been diagnosed with AFib? It must be, according to FDA, because FDA did not include this feature in its warning letter to WHOOP despite these claims being on WHOOPs website at the time of the investigation.[13] The Guidance’s new language that says FDA will consider whether the feature is intended to substitute for an FDA-cleared device[14] could provide FDA in the future a means of enforcing against this type of claim. But based on Commissioner Makary’s statements, there does not appear to be any current appetite to do so.
FDA also showed it was not ready to be hands-off with continuous glucose monitors ("CGM"), which can integrate with wearable health tech. FDA recently cleared certain continuous glucose monitors for non-diabetic adults that provide insights into the impact of diet and exercise on blood sugar levels. These devices merely access the interstitial fluid via a minimally invasive micro-needle. However, because this punctures the skin, the devices were not “low risk” under the previous version of the Guidance and therefore not eligible for exemption. With the release of the new language intended to be less restrictive, the Agency could have used this update as opportunity to carve out a place for these products in the policy. But instead, FDA added a specific example about CGMs, making it clear that these products will remain regulated solely because it punctures the skin.[15] So for the time being, companies should be advised that Agency does not appear ready to bend on what it considers “low risk.”
Despite the Commissioner’s blanket statements that merely providing information is okay so long as there is no reference to “medical grade,” there is still a lot of gray area that requires careful consideration for any wearable tech company thinking about marketing a feature that measures a user’s health data. While the Commissioner’s intent is helpful in understanding that FDA currently is less inclined to take action on health tech, keep in mind that Commissioners come and go, but the Guidance remains until it is superseded or rescinded.
[1] Warning Letter from FDA to WHOOP, Inc., July 14, 2025, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/whoop-inc-709755-07142025 (herein “WHOOP Warning Letter).
[2] FDA, General Wellness Guidance, Jan. 6, 2026, https://www.fda.gov/media/90652/download.
[3]Id. at 3-8.
[4] Tom Hale, With Less Regulation, Your Oura Ring Could Do More, Wall St. J., Dec. 19, 2025.
[5] WHOOP Warning Letter.
[6] Press Release, WHOOP, We Stand By Our Blood Pressure Insights Feature, July 18, 2025 https://www.whoop.com/us/en/press-center/we-stand-by-our-blood-pressure-insights-feature/.
[7] Fox Business News, FDA Announces Major Shift on Wearable Health Tech as AI Revolution Accelerates, Jan. 6, 2026, https://www.foxbusiness.com/video/6387305587112 (last visited Jan. 8, 2026).
[8] General Wellness Guidance at 6.
[9]Id. at 9.
[10] Which prompts the question of whether FDA considers the product exempt under the Federal Food, Drug, and Cosmetic Act § 520(o)(1)(B) or if it is simply exercising enforcement discretion. If the former, FDA would have no means of investigating whether the ranges are validated.
[11]See Letter from FDA to Apple, Inc. re: 510(k) Clearance for Irregular Rhythm Notification Feature, K231173 (July 21, 2023), https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231173.pdf; Letter from FDA to Fitbit, re: 510(k) Clearance for Fitbit Irregular Rhythm Notifications, K2122372 (April 8, 2022), https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212372.pdf; Letter from FDA to Samsung Electronics, Co. re: 510(k) Clearance for Samsung ECG App v 1.3 (ECG), K240909 (Aug. 2, 2024), https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240909.pdf.
[12]See How WHOOP Works, WHOOP https://www.whoop.com/us/en/how-it-works/ (last visited Jan. 4, 2026) (scroll to “Stay connected to your heart” and click on “01 Take on-demand ECGs”).
[13]See How WHOOP Works, WHOOP https://web.archive.org/web/20250520171105/https://www.whoop.com/us/en/how-it-works/ (WHOOP’s archived website on May 20, 2025).
[14] General Wellness Guidance at 5. Note that similar language was in the previous version but only in the context of whether the device was low risk.
[15]Id. at 9-10.
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