What is the Origin of General Wellness Policy?

This policy was established by the FDA to clarify the regulatory status of a growing category of consumer-focused digital health technologies that pose minimal risk to users. Recognizing that regulating every health-related app as a medical device would stifle innovation, the FDA created this policy to focus its resources on higher-risk technologies. The policy outlines two main categories: products that only promote general wellness and products that promote general wellness but also reference a disease or condition.

What is the Mechanism of General Wellness Policy?

A product is deemed to meet the policy's criteria if its intended use relates only to general wellness and does not make claims that it is intended to diagnose, cure, mitigate, treat, or prevent a disease. Furthermore, the product must pose a low risk to the user's safety. This mechanism acts as a regulatory filter, allowing innovators in the hormonal health and longevity space to develop lifestyle-focused tools without navigating the extensive medical device approval pathways, thereby accelerating the availability of non-clinical support tools.

General Wellness Policy ∞ Area

General Wellness Policy

Meaning

The General Wellness Policy, as defined by the US Food and Drug Administration (FDA), provides a regulatory boundary for low-risk, general wellness products, including certain software and mobile applications, that promote a healthy lifestyle. Products falling under this policy are not considered medical devices and therefore do not require the rigorous premarket review and clearance process, provided they adhere to specific criteria. This distinction is critical in the digital health space, separating tools for lifestyle improvement from those intended for diagnosis or treatment of disease.