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Proceedings Paper

Overview of FDA approval paths optical surgical navigation
Author(s): Paula M. Jacobs
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Paper Abstract

The development of drugs and devices to guide surgical resection of tumors in the United States requires the approval of the US Food and Drug Administration. Because these combine a drug and a device, the regulatory pathways can be confusing, particularly to academics or small companies. This paper discusses some of the issues and provides some guidance in this area.

Paper Details

Date Published: 8 February 2017
PDF: 5 pages
Proc. SPIE 10049, Molecular-Guided Surgery: Molecules, Devices, and Applications III, 100490S (8 February 2017); doi: 10.1117/12.2257152
Show Author Affiliations
Paula M. Jacobs, National Cancer Institute (United States)

Published in SPIE Proceedings Vol. 10049:
Molecular-Guided Surgery: Molecules, Devices, and Applications III
Brian W. Pogue; Sylvain Gioux, Editor(s)

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