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.
Paula M. Jacobs, "Overview of FDA approval paths optical surgical navigation," Proc. SPIE 10049, Molecular-Guided Surgery: Molecules, Devices, and Applications III, 100490S (Presented at SPIE BiOS: January 29, 2017; Published: 8 February 2017); https://doi.org/10.1117/12.2257152.
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