Whoop: Has the FDA backed down with its 2026 guidance?
FDA Commissioner Marty Makary has updated guidance that significantly shifts wearable regulation by expanding the existing exemption for “General Wellness” uses.
While WHOOP’s 2025 battle with the FDA acted as a catalyst for these changes, the company is not entirely “in the clear”—the rules of engagement have been redefined to allow features to exist within strict, non-medical boundaries. Nevertheless, this represents a surprising win for WHOOP.
Image|WHOOP, Team Invictus
The WHOOP Case: Regulatory Compromise
A 2025 warning letter focused on WHOOP’s “Blood Pressure Insights” (BPI), which the FDA considered to be a high-risk medical claim. Under the new policy from 2026, the situation has shifted.
A validated biomarker is OK. Claims of medical monitoring are not OK.
Validated Biomarkers: WHOOP can continue to display blood pressure data as a “biomarker” to assess recovery and activity levels.
Mandatory Validation: Metrics must be reasonably validated, i.e. through peer-reviewed literature or internal testing.
Clinical Claims: WHOOP remains prohibited from marketing the device as a “blood pressure monitor” for clinical (diagnostic) use.
No Alerts: The software cannot provide prompts for clinical action, such as recommending changes to medication, but can prompt you to seek medical advice.
Included vs. Excluded Metrics
The new guidance extends well beyond blood pressure and classifies other commonly used metrics by risk and intended use. These metrics are permitted when used for fitness or recreational tracking:
Heart Rate & Pulse: Tracking impact during sports or assessing activity and recovery.
Oxygen Saturation (SpO2): Permitted for monitoring fitness levels during activities like hiking at altitude.
Heart Rate Variability (HRV): Explicitly listed as an acceptable parameter for estimating stress and recovery.
Non-Invasive Glucose: Tracking nutritional impacts or insulin response.
Validated Blood Pressure: Only when used to assess recovery after exercise and not for managing hypertension.
These remain under strict FDA medical oversight and require 510(k) clearance:
Electrocardiogram (ECG): Excluded from general wellness when intended for screening or monitoring heart conditions.
Invasive Sensors: Any technology that pierces the skin (e.g., microneedle-based CGMs).
Clinical Diagnosis: Any device intended to cure, treat, or prevent a specific disease.
Conclusion
A win for commonsense.
This must be seen as a win for Whoop. There’s no need for the expense and uncertainty of any kind of legal action, and their ‘lifestyle blood pressure trend monitoring’ perhaps needs to have its messaging tweaked, but remains unchanged at its core. The regulatory framework for blood pressure trend, ECG and other medical-adjacent metrics sits within a rapidly evolving recovery tracker and lifestyle band category that is attracting investment and legal scrutiny in equal measure.
Last Updated on 25 May 2026 by tfk the5krunner
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tfk is the founder and author of the5krunner, an independent endurance sports technology publication. With 20 years of hands-on testing of GPS watches and wearables, and competing in triathlons at an international age-group level, tfk provides in-depth expert analysis of fitness technology for serious athletes and endurance sport competitors. ID
A win for common sense, yes. A win for Whoop? I don’t thing so. If you explicitly market a device as „medical grade“ it has to be certified at medical grade level. If not, it’s fraud.
yes, they will have to re-message slightly.