[Federal Register Volume 74, Number 73 (Friday, April 17, 2009)]
[Notices]
[Page 17872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-8774]



[[Page 17872]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0010]


Draft Guidance for Industry and Food and Drug Administration 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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availability of the draft guidance entitled ``Investigational Device 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 This draft guidance 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 This draft guidance is not 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.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115 (g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by July 16, 2009.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``Investigational Device Exemption (IDE) 
Guidance for Retinal Prostheses'' to the Division of Small 
Manufacturers, International, and Consumer Assistance (HFZ-220), Center 
for Devices and Radiological Health, Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850.
    Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 240-276-3151. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit written comments concerning this draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.regulations.gov. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Everette T. Beers, Center for Devices 
and Radiological Health, HFZ-460, Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-4200.

SUPPLEMENTARY INFORMATION:

I. Background

    A retinal prosthesis is a visual prosthetic device, implanted on or 
beneath the retina or on the outer surface of the globe, that uses 
electrical stimulation to provide some level of visual stimulation for 
persons suffering from degenerative retinal conditions. This draft 
guidance helps device manufacturers submit an IDE to FDA so that they 
may conduct feasibility and/or pivotal human clinical trials of their 
retinal prostheses in the United States in order to support a premarket 
approval application (PMA). The draft guidance provides recommendations 
about pre-clinical and clinical tests of retinal prosthetic devices. 
The draft guidance does not apply to prostheses that stimulate the 
optic nerve or other higher brain areas such as the visual cortex or 
the lateral geniculate nucleus.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized will represent the agency's current thinking on 
investigational device exemption (IDE) applications for retinal 
prostheses. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. To receive ``Investigational Device Exemption 
(IDE) Guidance for Retinal Prostheses,'' you may either send an e-mail 
request to [email protected] to receive an electronic copy of the 
document or send a fax request to 240-276-3151 to receive a hard copy. 
Please use the document number 1651 to identify the guidance you are 
requesting.
    CDRH maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 812 have been 
approved under OMB control number 0910-0078; collections of information 
in 21 CFR parts 50 and 56 have been approved under OMB control number 
0910-0130; and collections of information in 21 CFR part 814, subpart 
E, have been approved under OMB control number 0910-0231.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. Received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: February 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-8774 Filed 4-16-09; 8:45 am]
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