Navigating the FDA’s 2026 General Wellness guidance for digital health

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In digital health, regulatory clarity often matters as much as technical capability. While teams strive for speed and engagement, the regulatory line often acts as a friction point.

The FDA’s updated 2026 guidance provides additional clarity on how certain digital health and wellness products may be assessed under the General Wellness framework. While the guidance does not change the fundamentals of medical device regulation, it offers more explicit signals around how low-risk, non-invasive technologies may be positioned when used for lifestyle awareness rather than clinical decision-making. For teams building camera-based vitals monitoring into wellness or preventive health experiences, this clarification is operationally important.

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What changed

The FDA’s 2026 update refines how “general wellness” products are evaluated, particularly in the context of modern sensing technologies and software-driven experiences.

At a high level, the guidance reinforces that products intended for:

- lifestyle awareness,

- habit formation,

- self-reflection and education,

may fall outside active medical device enforcement when they do not make disease-related claims or drive clinical action.

The update also acknowledges that contemporary sensors - when used appropriately - can support wellness-oriented experiences without automatically being treated as medical devices. Importantly, this does not eliminate regulation; it clarifies how intent, claims, and context influence classification.

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Wellness vs medical use

While the guidance provides more clarity, the distinction between wellness software and regulated medical devices remains firm.

In practice, a product is unlikely to qualify as a general wellness product if it:

- claims to diagnose, treat, or prevent disease,

- references clinical thresholds or abnormal values (e.g. “high blood pressure”),

- generates alerts framed as medical warnings,

- recommends specific treatments or replaces FDA-cleared diagnostic tools.

The same physiological signal can fall on either side of this boundary depending on how it is used. For example, estimating heart rate to help users understand fitness or recovery trends may be considered wellness-oriented. Using that same estimate to identify or diagnose a cardiac condition would move the software into regulated medical territory.

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Interpreting “safe use”

The 2026 guidance discusses conditions under which non-invasive sensing technologies may be used in wellness contexts. This does not constitute blanket permission for all parameters or use cases.

Instead, it reinforces several guardrails that teams must design around:

- Claims and positioning: Outputs must be presented as lifestyle or wellness information, not medical assessments.

- Validation for intended use: Even wellness-oriented outputs should be technically validated to ensure they are appropriate for their stated purpose.

- Clear disclaimers: Users should be explicitly informed that the product is not intended for medical diagnosis or treatment.

For camera-based monitoring, the technology itself is not the determining factor. Regulatory classification depends on how measurements are framed, communicated, and acted upon within the product experience.

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Where Shen AI fits in this landscape

Shen AI provides a high-performance measurement layer for camera-based vital signs. The Shen AI SDK focuses on extracting physiological signals (such as heart rate or HRV) and delivering them as structured outputs.

Crucially, Shen AI does not define medical intent, make diagnoses, or determine how results are interpreted. That responsibility remains with the product team integrating the SDK.

This separation allows partners to design compliant experiences by:

- presenting data as trends or lifestyle estimates,

- using neutral, non-clinical language,

- designing escalation paths that encourage consultation with a healthcare professional without naming specific conditions or triggering diagnostic claims.

Shen AI supports this flexibility by remaining agnostic to downstream workflows and regulatory positioning.

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Designing responsibly

The FDA’s updated guidance does not remove regulatory responsibility from product teams. Instead, it highlights where careful design choices matter most: claims, UX language, thresholds, and decision logic.

By decoupling signal extraction from medical interpretation, teams can integrate camera-based vitals monitoring into wellness and preventive health experiences, provided they align their product design with the intended regulatory category.

Shen AI enables accurate, device-free measurements. How those measurements are positioned, communicated, and used remains a product and compliance decision for each organization.

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