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Bringing a New Medical Device to Market
Andrew Blitzer, MD, DDS;
William J. Binder, MD;
I. Sidney Jaffee, MD
Arch Facial Plast Surg. 2000;2:64-65.
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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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Many clinicians have wonderful ideas for new drugs and devices, but they are not certain how to bring them to market. Generally, a clinician should contact an intellectual properties lawyer to help protect an idea. Then the clinician may approach a company with the idea, although it is advisable to have a patent application filed before any conversations with an industrial partner take place. Next, confidentiality agreements are signed by both parties. If the idea is accepted, the Food and Drug Administration (FDA) applications for testing and marketing approval can be filed. If the clinician feels he or she can accomplish the filing and testing independently, he or she can file alone.
The application for medical devices has been well described in the companion article by Jaffee.1 The definition of a medical device is
an instrument, apparatus, implement, . . . [Full Text of this Article]
From the Department of Otolaryngology, Columbia University, and the New York Center for Voice and Swallowing Disorders, Columbia University, New York, NY (Dr Blitzer); Division of Head and Neck Surgery, University of California, Los Angeles (Dr Binder); and Ear, Nose, and Throat Devices Branch, US Food and Drug Administration, Rockville, Md (Dr Jaffee).
RELATED ARTICLE
The Food and Drug Administration: An Agency to Protect the Patient and the Physician
Arch Facial Plast Surg. ;2():62-63.
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