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GUIDANCE DOCUMENT

Investigational Device Exemption (IDE) Guidance for Retinal Prostheses Guidance for Industry and FDA Staff March 2013

Final

Investigational Device Exemption (IDE) Guidance for Retinal Prostheses

Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.