Overview of FDA approval paths optical surgical navigation

Paula M. Jacobs

doi:10.1117/12.2257152

8 February 2017 Overview of FDA approval paths optical surgical navigation

Paula M. Jacobs

Proceedings Volume 10049, Molecular-Guided Surgery: Molecules, Devices, and Applications III; 100490S (2017) https://doi.org/10.1117/12.2257152
Event: SPIE BiOS, 2017, San Francisco, California, United States

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

Citation Download Citation

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); https://doi.org/10.1117/12.2257152

ACCESS THE FULL ARTICLE

INSTITUTIONAL
Select your institution to access the SPIE Digital Library.

SELECT YOUR INSTITUTION

PERSONAL
Sign in with your SPIE account to access your personal subscriptions or to use specific features such as save to my library, sign up for alerts, save searches, etc.

PERSONAL SIGN IN

No SPIE Account? Create one

PURCHASE THIS CONTENT

SUBSCRIBE TO DIGITAL LIBRARY

50 downloads per 1-year subscription

Members: $195

Non-members: $335 ADD TO CART

25 downloads per 1 - year subscription

Members: $145

Non-members: $250 ADD TO CART

PURCHASE SINGLE ARTICLE

Includes PDF, HTML & Video, when available