Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Investigational Device Exemption (IDE) Guidance for Retinal Prostheses." This guidance document describes FDA's recommendations for clinical investigations of medical devices indicated for the treatment of visual impairments resulting from retinal diseases.