Copyright 2003 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2003
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.
Casler JD. Clinical Use of New Technologies Without Scientific Studies. Arch Otolaryngol Head Neck Surg. 2003;129(6):674–677. doi:10.1001/archotol.129.6.674
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