FDA WARNING_LETTER - Lady-Comp USA - December 06, 2010

The FDA issued a Warning Letter to Lady-Comp USA and RaXMedical, Inc. for marketing Lady-Comp USA, Baby-Comp, and Pearly fertility monitors without proper marketing approval, violating the Federal Food, Drug, and Cosmetic Act. The Office of Compliance reviewed the firms' websites, www.ladycompusa.com and www.raxmedical.com, which advertised these products.

The FDA had previously cleared a premarket notification (510(k)) for Lady-Comp USA (K050094) on April 20, 2006, solely for measuring and recording basal body temperature (BBT) as an aid in ovulation prediction to facilitate conception, explicitly stating it was "not to be used for contraception." However, the websites promoted Lady-Comp, Baby-Comp, and Pearly for contraceptive uses with statements such as "assists with safe, reliable and natural birth control" and "assists with family planning and reduced fertility."

These products are considered adulterated under Section 501(f)(1)(B) of the Act because they lack an approved premarket approval (PMA) or investigational device exemption (IDE) for their promoted contraceptive uses. Furthermore, Lady-Comp USA is misbranded under Section 502(a) because its websites misleadingly state, "Lady-Comp USA TM is an FDA approved fertility monitor," creating an impression of official approval when it was only