Developing, Regulating, and Ethically Evaluating New Technologies in Otolaryngology-Head and Neck Surgery

Richard R. Orlandi, Bradley F. Marple

Research output: Contribution to journalReview article

5 Scopus citations

Abstract

New technologies continue to affect the practice of otolaryngology-head and neck surgery. Numerous financial and regulatory barriers must be overcome to develop an idea into a useful device or intervention. US Food and Drug Administration (FDA) approval focuses on safety, often leaving the medical community, in general, to determine the efficacy of the device after FDA approval has been granted. Physicians are involved throughout the technology development process, generating conflicts of interest that must be effectively managed. It is essential that physicians ethically maintain their leadership in developing and evaluating new advances in medical technology.

Original languageEnglish (US)
Pages (from-to)739-745
Number of pages7
JournalOtolaryngologic Clinics of North America
Volume42
Issue number5
DOIs
StatePublished - Oct 1 2009

Keywords

  • Conflict of interest
  • Device
  • Disclosure
  • Regulatory approval
  • Technology

ASJC Scopus subject areas

  • Otorhinolaryngology

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