Peter B. Rosenquist, M.D. - Comment

Dear sirs: Thank you for the opportunity to submit a comment regarding the FDA review concerning the possible reclassification of ECT devices, or requiring the submission of a premarket approval application (PMA). As a board-certified psychiatrist and ECT practitioner, I would question the need for FDA action on this matter given the long-standing track record of safety and efficacy for ECT devices. Indeed, the longevity of this technology speaks to its enduring net value to the field, even as the rules and FDA scrutiny of devices has evolved from the time of the inception of ECT devices. As a NIH funded investigator on several ECT related clinical trials, I can say that we are well beyond questions of safety of the device and are working diligently to optimize treatment protocols to address the important public health problem of severe mood disorders. To require manufacturers and researchers in this extremely small coterie to readdress a relatively settled question could easily detract from the work that is being done currently, and add to health-care costs without adding any real value as regards safety. Sincerely, Peter B. Rosenquist, M.D. Associate Professor of Psychiatry Wake First University Health Sciences Medical Center Blvd. Winston-Salem, North Carolina e-mail: rosenqui@wfubmc.edu