FDA WARNING_LETTER - Valley Electronics GmbH

On December 6, 2010, the FDA issued a Warning Letter to Valley Electronics GmbH regarding their Lady-Comp, Baby-Comp, and Pearly fertility monitors. The FDA determined these products are devices under Section 201(h) of the Act.

The FDA's Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed the firm's websites, http://www.lady-comp.de/en and https://shop.valley-electronics.ch/de/?lang=de_en. The review revealed that the firm is manufacturing and marketing these devices in the U.S. without marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act.

Specifically, the FDA had 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 (not to be used for contraception)." However, the firm's websites promote Lady-Comp, Baby-Comp, and Pearly for contraceptive uses, including claims like "Baby-Comp is suitable for . . . safe contraception," and "[Lady-Comp] is the ambitious, scientifically advanced cycle computer that was tried and tested for decades to ensure natural contraception."

These actions render the Lady-