ROU Policy

Research Only Use

“Research Use Only” (RUO) refers to products intended strictly for laboratory research and development purposes. These products are not approved for clinical or diagnostic use in humans or animals.

Key Considerations

Intended Use
RUO products are designed for scientific investigation, including basic research and test development. They are not intended to diagnose, treat, or monitor any medical condition.

Regulatory Status
Products labeled “For Research Use Only. Not for use in diagnostic procedures” are not subject to the same regulatory requirements as medical devices used in clinical settings.

Labeling Requirements
Proper RUO labeling is required to clearly communicate that the product is restricted to research applications. Misuse or misrepresentation of intended use may result in regulatory action.

Regulatory Oversight
Authorities evaluate intended use based on labeling, marketing, and distribution practices. Promotion or sale of RUO products for clinical purposes may violate regulations.

Advertising & Marketing Compliance

The Federal Trade Commission requires that all product-related claims be truthful, substantiated, and not misleading. Marketing materials must align with the stated research-only purpose of the product.