FDA WARNING_LETTER - BioVeda - January 08, 2010

During an FDA inspection from December 30, 2009, to January 8, 2010, BioVeda's BAX3000 device was found to be adulterated and misbranded. The BAX3000 is a device under section 201(h) of the Act.

The device is adulterated because BioVeda lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). It is misbranded under section 502(o) because the firm failed to provide a 510(k) notification for new intended uses, specifically for therapy to address allergies, asthma, IBS, migraines, eczema, celiac disease, chronic fatigue, and to strengthen the nervous system. Additionally, new 510(k)s are required to substantiate claims on the website regarding treatment of various conditions, including relief from allergy symptoms, poison ivy reactions, pet dander allergy, and normalization of behavior in children with ADD, ADHD, Autism, and Asperger's Syndrome, as well as alleviation of digestive problems. These claims significantly differ from the device's cleared intended use of relaxation training as a biofeedback device.

The BAX3000 is also misbranded under Section 502(o) due to the firm not being duly registered, not including the device in a required list, or not providing required notice/information under