Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device Exemption Guidance for Retinal Prostheses; Availability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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Investigational Device Exemption (IDE) Guidance for Retinal Prostheses." This draft guidance document provides recommendations to industry about developing pre- clinical and clinical tests of retinal prosthetic devices for submission to FDA in an IDE application. This draft guidance is not final nor is it in effect at this time.