Explaining the Absence of Surgical Procedure Regulation image

Cornell Journal of Law and Public Policy, Vol 27, Issue 189
Jonathan J. Darrow (Student Fellow Alumnus)


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From the paper:

Each year in the United States, surgeons perform approximately 64 million surgical procedures, ranging from tooth extraction to open heart surgery.2 Yet, notwithstanding the frequency of surgical procedures and their often critical importance to patient health, no state or federal agency either approves the use of new surgical procedures or directly regulates existing procedures.3 The absence of surgical procedure regulation differs from the regulation of new pharmaceutical products, which can be introduced into interstate commerce only after the Food and Drug Administration (FDA) has reviewed “adequate and well-controlled [clinical] investigations” and concluded the data from those studies sufficiently establish the drug’s safety and efficacy.4 Surgical procedures, by contrast, are more often conveyed from professor to student, the result being that surgical approaches may vary considerably from one geographic region to another.5 Whether different techniques produce different outcomes is not always clear, in part because the absence of regulation means that evidence often has not been systematically generated or may be in a form not suitable for comparison.


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bioethics health law policy regulation