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GUIDANCE DOCUMENT

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

Download the Final Guidance Document
Final
Docket Number:
FDA-2009-D-0010
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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0010.

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