FDA WARNING_LETTER - Ondamed GmBH

The FDA issued a Warning Letter to ONDAMED Inc. on June 1, 2015, for marketing the Ondamed System without required marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act. The device is intended for diagnosis, cure, mitigation, treatment, prevention of disease, or to affect body structure/function.

The FDA previously informed ONDAMED that the Ondamed System is not a biofeedback device under 21 CFR 882.5050. However, the firm registered and listed it as such, and continues to market it as a biofeedback system on its website, www.ondamed.net/us. The Ondamed System lacks the monitoring functionality essential for biofeedback devices, as it cannot measure, record, or monitor physiological parameters for voluntary patient control.

While biofeedback devices under 21 CFR 882.5050 are generally exempt from premarket notification, the Ondamed System is marketed for uses beyond those of legally marketed biofeedback devices, including treating or curing multiple sclerosis, breast cancer, blindness, Lyme disease, osteoporosis, and for smoking cessation. These intended uses exceed the exemption limitations in 21 CFR 882.9.

Consequently, the Ondamed System is deemed adulterated under section 501(f)(1)(B) of the Act because it lacks an approved premarket approval (PMA) or investigational device