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

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