FDA released an updated version of its General Wellness: Policy for Low Risk Devices guidance in January 2026. This update is intended to clarify when a product is better viewed as a low-risk general wellness offering and when it is more likely to be regulated as a medical device based on its intended use, outputs, and claims.
The gist: how FDA frames “general wellness” in 2026
FDA is basically drawing a bright line between:
- Wellness products (encourage healthy lifestyle, track trends, support general fitness/sleep/stress, etc.), and
- Medical devices (anything intended for diagnosis, treatment, monitoring/management of disease, or guiding clinical action).
And FDA repeats its long-standing position: for low-risk general wellness products, CDRH does not intend to examine whether they are devices or enforce many device requirements (registration/listing, labeling, QMS/QSR, MDR, etc.).
To be “general wellness” under this guidance, your product still has to meet two factors:
- Intended only for general wellness use, and
- Low risk to safety.
What’s new in the 2026 update
The overall approach is evolutionary (not a reset), but the 2026 version makes updates that directly address today’s wearables and wellness software:
1) FDA added a new, explicit “physiologic parameters” section (big update)
The 2026 guidance now directly addresses modern wearables that estimate/output things like blood pressure, oxygen saturation, blood glucose, HRV, etc.
FDA says those kinds of outputs can still fit the wellness lane only if they meet a tighter set of conditions, including (high level):
- non-invasive / not implanted
- not for diagnosis/treatment
- not a substitute for an FDA-authorized medical device
- no outputs/claims that push specific clinical action/medical management
- and don’t mimic clinical values unless validated (FDA even gives examples of validation sources).
This “validated values” expectation is a meaningful tightening — it’s basically FDA saying: “If you’re going to show numbers that look like clinical numbers, you better have evidence they actually reflect those values.”
2) Clearer “do’s and don’ts” for alerts/notifications
FDA also clarifies when a wellness product can nudge someone to seek care without becoming a medical device.
A “see a healthcare professional” notification can still be okay if it stays generic and avoids:
- naming diseases,
- calling something “abnormal/pathological,”
- using clinical thresholds,
- giving treatment guidance,
- and no ongoing disease-management monitoring.
3) New/expanded examples that reflect today’s wearable market
The 2019 guidance had Illustrative Examples 1–6.
The 2026 version expands and modernizes examples (now includes scenarios like wearables outputting multiple biomarkers including blood pressure, plus examples touching glucose and other advanced parameters) and repeatedly ties acceptability to validation and “wellness-only” positioning.
What changed in the criteria (what teams should watch)
The biggest practical shift is the tighter framing around wellness products that present physiologic measurements or measurement-like outputs. To stay aligned with general wellness positioning, teams should pay special attention to:
• Claims: avoid diagnosis, treatment, or disease-management language (including “clinically accurate” or “medical grade” unless you are prepared to support it with a device strategy).
• Outputs: be cautious with numeric values that resemble clinical readouts; avoid presenting the product as a substitute for an FDA-authorized device.
• Evidence and validation: if you provide measurement-like outputs, document how values are derived and why they are reliable for the intended wellness use.
• User risk: confirm the product remains non-invasive, non-implanted, and does not introduce safety risks that typically require active regulatory controls.
Practical takeaways
• Start with intended use and claims. Most wellness regulatory risk comes from “claim creep” in marketing and user-facing language.
• Align all customer-facing surfaces (labeling, app store descriptions, website copy, ads) to the same intended use story.
• If you plan to include advanced parameters (blood pressure, glucose insights, SpO2, arrhythmia-related features), consider a formal device strategy early rather than trying to stay “wellness” through wording alone.
How RQMIS can help
RQMIS helps companies make defensible decisions in the gray zone between wellness products and regulated medical devices. Depending on your product and business goals, our support can include:
• Product and claims assessment: map features, outputs, and claims to the 2026 guidance and the device definition to identify where you are in-scope vs. out-of-scope.
• Regulatory strategy and pathway selection.
• Evidence planning.
• Labeling and marketing review.
• FDA engagement support.