[Federal Register Volume 78, Number 44 (Wednesday, March 6, 2013)]
[Notices]
[Pages 14557-14558]
From the Federal Register Online via the Government Publishing 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
[email protected] 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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