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  Vol. 129 No. 6, June 2003 TABLE OF CONTENTS
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  Clinical Challenges in Otolaryngology
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Clinical Use of New Technologies Without Scientific Studies

Arch Otolaryngol Head Neck Surg. 2003;129:674-677.

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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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RELATED ARTICLES

Safety First
Neil O. Ward
Arch Otolaryngol Head Neck Surg. 2003;129(6):677.
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Arch Otolaryngol Head Neck Surg. 2003;129(6):678.
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THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

You Have a Friend at the FDA
Schoem
Arch Otolaryngol Head Neck Surg 2003;129:1358-1358.
FULL TEXT  

Surgical Innovation and Research
Gates
Arch Otolaryngol Head Neck Surg 2003;129:1352-1353.
FULL TEXT  





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