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I thoroughly enjoyed the well-organized article with thoughtful comments by John D. Casler, MD, titled "Clinical Use of New Technologies Without Scientific Studies" published in the June issue of the ARCHIVES.¹ He clearly and succinctly delineates the role of the Food and Drug Administration (FDA) in oversight of medical devices and the ethical dilemmas of developing new surgical procedures using new technologies.

I spent 3 fruitful years serving on the American Academy of Otolaryngology–Head and Neck Surgery Committee on Medical Devices and Drugs. During that time, I had the honor of reporting on oral appliances for snoring and the emerging technology using office-based carbon dioxide laser fenestration for otitis media. I immensely enjoyed collaboration with FDA colleagues who "showed me the ropes." I was impressed with the level of professionalism and caring attitude at the FDA branch on Medical Devices. More important, I quickly learned that the FDA is completely . . . [Full Text of this Article]

Scott R. Schoem, MD
Director of Otolaryngology
Connecticut Children's Medical Center
282 Washington St
Hartford, CT 06106
(e-mail: sschoem@ccmckids.org)