United States, January 6, 2026 — The Food and Drug Administration (FDA) has formally issued the final guidance document “General Wellness: Policy for Low Risk Devices”. This document was issued on January 6, 2026, and provides immediate clarity to industry and FDA staff regarding the compliance policy for low-risk products that promote a healthy lifestyle.
This new document officially supersedes the previous guidance titled “General Wellness: Policy for Low Risk Devices” issued on September 27, 2019.
The guidance clarifies that the FDA does not intend to enforce regulatory requirements for products that qualify as “general wellness products,” provided they are low risk.
FDA GENERAL WELLNESS POLICY ON LOW RISK DEVICES
For manufacturers, this publication confirms that if a product meets the specific definition of a “low risk general wellness product,” the FDA does not intend to examine it to determine if it is a device, nor will it enforce standard regulatory requirements.
Specifically, qualifying products are exempt from:
- Registration and listing requirements.
- Premarket notification (510(k)) requirements.
- Labeling requirements (21 CFR Part 801).
- Good manufacturing practice requirements (Quality Management System Regulation).
- Medical Device Reporting (MDR) requirements.
Note: This guidance does not apply to products regulated by other FDA Centers (e.g., drugs, biologics, dietary supplements) or combination products.
Criteria for General Wellness Products
To benefit from this policy, a product must meet two factors: (1) it must be intended for only general wellness use, and (2) it must present a low risk to safety.
The guidance categorizes “General Wellness” intended uses into two specific buckets:
- Maintaining a General State of Health These claims relate to sustaining or improving general health functions without referencing any specific disease or condition.
- Included Categories: Weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management, and sexual function.
- Example: A product that claims to “promote relaxation or manage stress”.
- Association with Chronic Diseases These claims relate to sustaining health while making reference to diseases, but only if they promote lifestyle choices that may help reduce the risk of or live well with a chronic disease.
- Requirement: The healthy lifestyle choice must be generally accepted and well understood to play a role in health outcomes (e.g., peer-reviewed scientific publications).
- Example: Software that tracks sleep and exercise which, as part of a healthy lifestyle, may help “live well with anxiety”.
Risk Factors & Exclusions
The “low risk” designation is critical. If a product falls into any of the following categories, it is excluded from this guidance and standard medical device regulations apply.
A product is NOT low risk if:
- It is Invasive: The product penetrates or pierces the skin or mucous membranes (e.g., needles).
- It is Implanted: Any product intended to be implanted in the body.
- It Involves Risky Technology: The product involves technology that may pose a risk to safety if controls are not applied, such as lasers or radiation exposure.
Example: Sunlamp products for tanning (radiation risk) or lasers for skin rejuvenation (burn risk) are not low risk.
Resources
To help manufacturers navigate these requirements, the following resources are available:
- Official Guidance: General Wellness: Policy for Low Risk Devices (PDF)
- Contact the FDA: For questions about this document, contact the Digital Health
- Center of Excellence by e-mail at [email protected].
- Request Copies: Additional copies of the guidance are available by sending an e-mail request to [email protected] quoting document number 1300013.