Academy of Clinical Sleep Disorders Disciplines - Comment

August 20, 2011 Nancy K. Stade Deputy Director for Policy, Center for Devices and Radiological Health Food and Drug Administration 5630 Fisher Lane, Room 1061 Rockville, Maryland 20852 Re: The Federal Register, Vol. 76, No. 152, pgs. 48062-48070. Proposed Rule: “Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator.” [Docket No. FDA-2011-N-0504]. Dear Ms. Stade: I am submitting this response at the request of the Food and Drug Administration (FDA) in its Proposed Rule for Cranial Electrotherapy Stimulation (CES) issued in the Federal Register on August 8, 2011 (76 F.R. 152, p. 48062). As a practitioner who uses CES in my practice, I wanted to share with FDA my own findings on the efficacy and safety of CES. I am well aware of the huge volume of scientific data that support the safety and effectiveness of CES. I am a user of CES and can attest to it value and results. You pending demands are far off the mark and place millions of users in harms way. If you prevail that end-result will be on your heads. Thank you for your attention to this matter. It is my hope that FDA will allow CES to be down-classified to a Class II device as it has proven itself to be both safe and effective. Sincerely, Dr. Michael J. Krahe Founder and Executive Director, Academy of Clinical Sleep Disorders Disciplines Carefree, AZ 85377