Document ID: FDA-2009-D-0010-0009
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Food and Drug Administration Staff; Availability: Investigational Device Exemption Guidance for Retinal Prostheses
Posted Date: 2013-03-06T05:00Z

[Federal Register Volume 78, Number 44 (Wednesday, March 6, 2013)]
[Notices]
[Pages 14557-14558]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05125]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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 guidance entitled ``Investigational Device 
Exemption (IDE) Guidance for Retinal Prostheses.'' This guidance 
document describes FDA's recommendations for clinical investigations of 
medical devices indicated for the treatment of visual impairments 
resulting from retinal diseases.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Investigational Device Exemption (IDE) Guidance for 
Retinal Prostheses'' to the Division of Small Manufacturers, 
International and Consumer Assistance, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-847-8149. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  For pre-clinical concerns:

[[Page 14558]]

Ethan D. Cohen, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 62, rm. 1204, 
Silver Spring, MD 20993-0002, 301-796-2485;

For clinical concerns:

Bernard P. Lepri, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 2404, 
Silver Spring, MD 20993-0002, 301-796-6501.

SUPPLEMENTARY INFORMATION: 

I. Background

    This guidance addresses the investigation of medical devices 
intended to manage permanent vision impairment resulting from ocular 
pathology such as retinitis pigmentosa. Vision impairment, or low 
vision, is vision that is not correctable to normal levels by 
spectacles, contact lenses, medications, surgery, or other techniques 
and devices. It is irreversible loss of vision due to disease, not 
refractive errors (myopia, astigmatism, presbyopia). This guidance is 
intended to assist device manufacturers who plan to conduct clinical 
investigations of devices indicated for the treatment of vision 
impairment in support of premarket approval (PMA) applications, 
humanitarian device exemptions, or premarket notification (510(k)) 
submissions. The guidance describes FDA's recommendations for human 
clinical trials that involve the use of any type of retinal prosthesis 
device, including, but not limited to, 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. This document 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.
    In the Federal Register of April 17, 2009 (74 FR 17872), FDA 
announced the availability of the draft guidance. Comments on the draft 
guidance were due by July 16, 2009. Six comments were received with 
each comment making multiple recommendations on changes to the content 
of the guidance document. The comments included recommended changes to 
primary, secondary, and functional vision endpoints and changes to the 
recommended clinical study design. In response to these comments, FDA 
has clarified the appropriate context for recommended endpoints and a 
sponsor's options with respect to use of a given endpoint. FDA also 
revised and clarified the recommendation regarding use of sham 
controls.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on 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 guidance may do so by 
using the Internet. A search capability for all CDRH guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``Investigational Device Exemption (IDE) Guidance for Retinal 
Prostheses,'' you may either send an email request to 
dsmica@fda.hhs.gov to receive an electronic copy of the document or 
send a fax request to 301-847-8149 to receive a hard copy. Please use 
the document number 1809 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This 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 (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 part 814 
(21 CFR part 814), subpart H, have been approved under OMB control 
number 0910-0332; collections of information in 21 CFR 56.115 have been 
approved under OMB control number 0910-0130; and collections of 
information in part 814, subpart E, have been approved under OMB 
control number 0910-0231.

V. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES), or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: February 28, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05125 Filed 3-5-13; 8:45 am]
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