01
The RUO framework
Research Use Only (RUO) is a regulatory classification for products intended solely for laboratory investigation. An RUO product is not a drug, not a dietary supplement, not a cosmetic, and not a medical device. It has not been reviewed, cleared, approved, or otherwise evaluated by the United States Food and Drug Administration for any use.
Because an RUO product carries no approved use, it is supplied without directions for use in humans, and no representation is made regarding safety or effect in humans. Material sold under this classification is intended to be handled by qualified personnel in a laboratory setting.
