Issue Date: March 6, 2013
Issued by: Center for Devices and Radiological Health
Topic(s): Investigational Device Exemption (IDE), Ophthalmic
Status: Final
Investigational Device Exemption (IDE) Guidance for Retinal Prostheses: Guidance for Industry and FDA Staff
This document is limited to retinal prostheses, (i.e., visual prosthetic devices implanted on or beneath the retina, and those on or beneath the outer surface of the globe), that use electrical stimulation to provide some level of visual perception for persons suffering from degenerative retinal conditions.
Download the Guidance Document
