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Clinical Use of New Technologies Without Scientific Studies
Arch Otolaryngol Head Neck Surg. 2003;129:674-677.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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Hypothesis: The Food and Drug Administration (FDA) approval process is often lengthy and complex, yet physicians generally want to afford their patients every benefit of the latest medical and surgical innovations. This dynamic tension begs the question, "Should new devices or surgical techniques be adopted into clinical practice before they are proven in scientific studies?"
To answer this question, it will be necessary to address medical devices and surgical techniques as separate topics because they are governed by different legal and ethical guidelines. While medical devices come under the regulatory jurisdiction of the FDA, the development of new surgical procedures does not.
MEDICAL DEVICES
BACKGROUND
The medical profession is dedicated to improving the health and well-being of patients. In our society, the government is dedicated to protecting the safety and well-being of its citizenry. Medical device manufacturers are dedicated to improving the lives of patients while, in most instances, increasing company profits. The . . . [Full Text of this Article] PRO CON BOTTOM LINE
SURGICAL PROCEDURES
BACKGROUND PRO CON BOTTOM LINE
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