In December 2025, Tom Hale, CEO of Oura, wrote an opinion piece in The Wall Street Journal, calling for a reformed regulatory structure for wellness products like Oura Ring.
Hale shared his view that “federal policy hasn’t caught up with technological advances,” noting that devices like Oura Ring, which provide continuous, noninvasive biometric data, often fall into a „regulatory gray area” between low-risk wellness products and high-risk medical devices.
As Hale wrote, “[Wearable] sensors are used for both purposes, so there’s often a mismatch between the actual risk and the imposed regulatory burden. Manufacturers are faced with a choice: tailor their features to the wellness category, sacrificing functionality, or accept slower product development and market entry.”
In the article, Hale calls for a third category: “digital health screeners,” designed to bridge the gap between general wellness products and medical devices. This classification would allow for valuable new features leveraging sophisticated sensing capabilities, like high blood pressure or sleep apnea screening, without the significant regulatory process for a full medical diagnostic tool.
As part of this new regulatory pathway, manufacturers of digital health screeners should have to meet appropriate accuracy and reliability standards. At Oura, our health‑sensing technology for health metrics such as heart rate, heart rate variability, and sleep staging analysis has been validated by third-party research.
Updated Guidelines from the FDA
Oura’s vision moved one step closer to reality on January 6, 2026, when the U.S. Food & Drug Administration (FDA) issued a revised version of the General Wellness Policy for Low Risk Devices, which was last updated in 2019. This update clarifies and expands the FDA’s view of what types of software-based and sensor-enabled products constitute low-risk general wellness tools.
In the new guidance, the FDA defines a “general wellness product” as a product with an intended use that relates to:
- maintaining or encouraging a general state of health or a healthy activity, or
- the role of healthy lifestyle in helping to reduce the risk or impact of certain chronic diseases or conditions, where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.
TL;DR: The FDA defines a “general wellness product” as something meant to support overall health or healthy habits, including products that encourage lifestyle choices (like exercise or diet) that are widely known to help lower the risk or impact of certain chronic conditions.
Key Updates from the FDA
Blood Pressure Guidelines
Perhaps the most notable change is the FDA’s updated policy regarding blood pressure. In 2025, the FDA released a safety communication maintaining that products measuring or estimating blood pressure did not fall within the FDA’s policy for general wellness products “because they are not intended solely for a general wellness use and are not low risk.”
The newly revised guidance has updated language stating that non-invasive wearables estimating blood pressure, such as with a photoplethysmogram, can qualify as general wellness products if they are strictly wellness-focused and don’t intend to diagnose specific diseases or clinical conditions like hypertension.
Glucose Levels
There is new language in relation to estimating blood glucose levels. Per the FDA policy, a product measuring or estimating blood glucose levels can be classified as a general wellness product if it is intended for nutritional monitoring, fitness, or general healthy living purposes, such as tracking how different foods affect glucose levels in healthy individuals, and explicitly states that it is not for use by individuals with diabetes or pre-diabetes.
READ MORE: How Does the Stelo Glucose Biosensor Work?
Proactive Guidance
The FDA clarified that general wellness products can suggest when it might be helpful to consult a healthcare professional if your data falls outside ranges appropriate for general wellness use. To remain within the wellness category, these notifications cannot name any particular diseases or medical conditions, cannot provide specific medical thresholds, diagnoses, or advice on treatment, and are prohibited from using persistent alerts or continuous monitoring designed to track a chronic illness.
It is important to note that while the FDA is broadening the General Wellness Policy for Low Risk Devices, they are maintaining a clear line regarding clinical safety and products that would constitute medical devices.
What This Means For Oura
Dr. Ricky Bloomfield, Chief Medical Officer at Oura, is optimistic about how these changes can support technology and innovation at Oura and benefit Oura Members. “The FDA’s revised policy represents a pivotal milestone in the evolution of personal health technology,” Bloomfield says.
“By providing a clearer framework for non-invasive metrics like blood pressure estimation and metabolic health tracking, as well as notifications in a general wellness context, the FDA is acknowledging that wearables can safely play a role in proactive approaches to health through personalized insights.”
Oura will continue our steadfast commitment to rigorous science, research, and validation. We are excited to push the boundaries of what’s possible to serve our members well while ensuring that every advancement remains grounded in proven science and aligned with regulatory guidance.
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