Is FDA Device Exemption for Deep Brain Stimulation Being Misused?

February 18, 2011

The US Food and Drug Administration’s (FDA’s) humanitarian device exemption (HDE) for the use of deep brain stimulation (DBS) to treat severe obsessive-compulsive behavior (OCD) may put patients at risk and should be revised, an analysis/commentary published in the February issue of Health Affairs suggests. (Medscape)