8 February 2017 Overview of FDA approval paths optical surgical navigation
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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.
Conference Presentation
© (2017) COPYRIGHT Society of Photo-Optical Instrumentation Engineers (SPIE). Downloading of the abstract is permitted for personal use only.
Paula M. Jacobs, "Overview of FDA approval paths optical surgical navigation", Proc. SPIE 10049, Molecular-Guided Surgery: Molecules, Devices, and Applications III, 100490S (8 February 2017); doi: 10.1117/12.2257152; https://doi.org/10.1117/12.2257152
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