Intended use under FDA General Wellness

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This article applies to products intended for the United States market. If your application is distributed outside the US, different regulatory frameworks may apply.

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If you're planning to launch a wellness application in the US, one of the first concepts to understand is intended use.

The FDA doesn't regulate technologies simply because they measure health-related data. Instead, it looks at how your product is positioned, what claims it makes, and how users are expected to use it.

In other words, the same underlying technology can fall under different regulatory pathways depending on how it's presented.

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It's about the product, not just the measurement

The FDA's updated General Wellness guidance recognizes that modern, non-invasive technologies, including camera-based health monitoring, can provide physiological information as part of a wellness product when they are positioned appropriately.

There is, however, an important question: "What is your application intended to do with those measurements?"

Applications focused solely on maintaining or encouraging a healthy lifestyle and whose intended use is unrelated to the diagnosis, cure, mitigation, prevention or treatment of a disease or condition, may fall within the General Wellness framework, provided that they present a low risk to users. Products intended to diagnose, treat, monitor diseases, or guide clinical decisions are subject to different regulatory requirements.

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What General Wellness does not allow

Understanding these boundaries is just as important as understanding what is allowed. The FDA's general wellness policy excludes applications that provide clinical functionality or make medical claims.

As a result, an application should not:

- diagnose or screen for a disease or condition;
- classify results as normal, abnormal, hypertensive or clinically significant;
- monitor the progression or control of a disease;
- generate medical alerts or treatment recommendations;
- instruct users to start, stop or change medication;
- claim that the application replaces a medical device or healthcare professional;
- use health-risk outputs that are presented as disease prediction or clinical assessment.

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Shen AI offers two approaches for US products

Depending on your product strategy, you have two options.

General Wellness SDK US is a dedicated SDK designed specifically for applications targeting the US market under the FDA General Wellness framework. It uses simplified terminology, excludes disease-related insights and health risk indices, and is intended for teams that prioritize a lower regulatory burden. This is a separate SDK and requires its own integration.

If your application serves multiple markets, you don't necessarily need a separate implementation. The standard Shen AI SDK (also called Wellness Global) includes an optional V3 design mode, which provides a General Wellness-aligned user experience for US users while allowing you to keep the broader feature set for other regions. The V3 interface can be selected during SDK initialization.

Choosing between these approaches depends on your product, target markets, regulatory strategy, and desired feature set.

If you're unsure which option is the right fit, contact the Shen AI team. We'll help you determine whether the dedicated General Wellness SDK US or the Global SDK with V3 design mode is the better approach for your application.

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Intended use goes beyond the SDK

Remember that intended use isn't determined by the SDK alone.

The FDA considers the complete product experience, including your App Store listing, onboarding, results screens, notifications, website, and marketing materials. All of these contribute to how your product is interpreted by regulators and users alike.

Learn more about FDA General Wellness from our webinar recording:

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Or read the webinar recap here.

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Additional resources

This article provides a high-level introduction. For a detailed explanation of the FDA's 2026 General Wellness update, intended use, product positioning, and practical implementation guidance, see our report: