Copyright 2003 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2003
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.
Schoem SR. You Have a Friend at the FDA. Arch Otolaryngol Head Neck Surg. 2003;129(12):1358. doi:10.1001/archotol.129.12.1358