FDA Guidance on General Wellness: Policy for Low-Risk Devices 

The FDA released a revised final version of its guidance, General Wellness: Policy for Low Risk Devices, on January 6, 2026. This update supersedes the previous version issued in September 2019.  

The guidance clarifies which wellness apps, wearables, and other low risk health tools fall outside FDA medical device oversight, outlining what counts as a general wellness claim and how low risk status is determined. 

What is a “General Wellness Product”? 

A general wellness product is a tool—often a wearable, app, or consumer health gadget—that supports overall health or healthy behaviors without making medical claims or performing medical functions. 

Per the FDA guidance, a general wellness product must satisfy two conditions:  

1. Intended solely for general wellness use: The intended use should focus on: 

• Maintaining or promoting overall health or healthy behaviors, or 

• Linking healthy lifestyle practices with reducing the risk or lessening the impact of certain chronic diseases or conditions. 

2. Presents low risk to safety: It must be non-invasive, non-implanted, and not involve technologies that may pose a risk to the safety of users or other persons. 

Key Updates in the 2026 FDA General Wellness Guidance 

• Criteria Classification: It clarifies what qualifies as a general wellness product not regulated as a medical device. FDA sharpened its definitions of general wellness claims and lowrisk criteria, making it easier for companies to determine which products fall outside the medicaldevice framework. 

• Expansion of Physiological Parameters: The FDA now allows non-invasive products (like wearables) to estimate, infer, or output physiologic parameters such as blood pressure, oxygen saturation, blood glucose, and heart rate variability to be used for general wellness purposes without being regulated as medical devices, provided they do not reference specific diseases or diagnostic thresholds. 

• Expanded examples of acceptable general wellness technologies: The guidance includes certain sensor-based wearables that track non invasive physiological parameters. 

• Indication to Seek Professional Care: The guidance clarifies that a product may still qualify as a general wellness product even if it includes a notification suggesting a user to consult a healthcare professional when outputs fall outside a normal range, as long as the notification stays within strict boundaries (no disease references, no “abnormal” labeling, no treatment advice). 

Why It Matters 

• Clearer Regulatory Expectations and Reduced Uncertainty: 
  • The updated guidance expands the types of wellness technologies that can operate outside FDA medical device regulation, giving developers more flexibility to innovate without triggering full device requirements. 
  • Clearer definitions of general wellness claims, low risk criteria, and acceptable user notifications give companies a better understanding of regulatory boundaries, reducing guesswork, legal risk, and the need for case by case FDA engagement. 

• Innovation Support:  
  • Wearables and apps have evolved far beyond stepcounting. The updated guidance reflects this by addressing modern capabilities such as noninvasive sensing of physiological parameters and clarifying when these features still qualify as general wellness.  
  • By allowing more advanced features (e.g., estimating blood pressure or glucose for wellness purposes) but prohibiting diseasespecific claims or diagnostic interpretations, the FDA balances flexibility with safety. Developers can build richer tools without misleading users. 

• Reflects Real World Consumer Use of Wellness Technology: 
  People increasingly rely on wearables and apps to monitor their health. The updated policy acknowledges this reality and provides a framework that reflects current consumer behavior and technological capabilities.  

How MedEnvoy Can Support  

MedEnvoy supports medical device manufacturers in navigating evolving FDA guidance by translating regulatory expectations into clear, actionable strategies. Our team provides end-to-end support across regulatory planning, FDA engagement, and clinical evidence development to help reduce uncertainty and avoid downstream delays. We assist with early FDA interactions, including premarket strategy and submission preparation. To learn more about our FDA Agent services, click here. If you have any questions regarding this summary or the accompanying guidance document, we encourage you to reach out to our regulatory experts, here.