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Clinical Challenges in Otolaryngology
June 2003

Clinical Use of New Technologies Without Scientific Studies

Author Affiliations
 

KAREN H.CALHOUNMD

 

RONALD B.KUPPERSMITHMD

Arch Otolaryngol Head Neck Surg. 2003;129(6):674-677. doi:10.1001/archotol.129.6.674

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.

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