[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4281-4282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01407]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1849]
Medical Devices and Clinical Trial Design for the Treatment or
Improvement in the Appearance of Fungally-Infected Nails; Draft
Guidance for Industry and Food and Drug Administration Staff;
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availability of the draft guidance entitled ``Medical Devices and
Clinical Trial Design for the Treatment or Improvement in the
Appearance of Fungally-Infected Nails.'' This guidance is intended to
provide recommendations when finalized regarding clinical trial design
for medical devices intended either to provide improvement in the
appearance of nails affected by onychomycosis or to treat onychomycosis
(fungal nail infection). This draft guidance is not final nor is it in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 of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 27, 2015.
ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Medical Devices and Clinical Trial Design for the Treatment or
Improvement in the Appearance of Fungally-Infected Nails'' to the
Office of the Center Director, Guidance and Policy Development, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your request.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Neil Ogden, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G414, Silver Spring, MD 20993-0002, 301-796-6397.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
and FDA staff entitled ``Medical Devices and Clinical Trial Design for
the Treatment or Improvement in the Appearance of Fungally-Infected
Nails.'' This guidance is intended to provide recommendations when
finalized regarding clinical trial design for medical devices intended
either: (1) To provide improvement in the appearance of nails affected
by onychomycosis, that is, to affect the structure/function of the
nails or (2) to treat onychomycosis (fungal nail infection).
The FDA distinguishes these two conditions as target outcomes. The
treatment of onychomycosis (an infectious disease) requires proof of
stable elimination of the fungal organism, which is a medical endpoint.
This outcome is distinct from outcomes limited to ``temporary increase
in clear nail'' in nails which are fungally infected, which is
considered an aesthetic endpoint, and does not connote successful
eradication of fungal infection. The need for clinical performance data
will be dependent on
[[Page 4282]]
the design and use of the device. This guidance is intended to provide
information related to both indications, when the device is applied to
nails with confirmed fungal infection.
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 clinical
trial design for the treatment or improvement in the appearance of
fungally infected nails. 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 downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Medical Devices and Clinical
Trial Design for the Treatment or Improvement in the Appearance of
Fungally-Infected Nails'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 1400009 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; the collections of information in 21 CFR
part 807, subpart E have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 814 have been
approved under OMB control number 0910-0231; the collections of
information regarding adverse events have been approved under OMB
control number 0910-0471; and the collections of information in 21 CFR
part 801 have been approved under OMB control number 0910-0485.
The labeling recommendations of this draft guidance are not subject
to review by the Office of Management and Budget because they do not
constitute a ``collection of information'' under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the recommended
labeling is a ``public disclosure of information originally supplied by
the Federal Government to the recipient for the purpose of disclosure
to the public.'' (see 5 CFR 1320.3(c)(2)).
V. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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: January 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01407 Filed 1-26-15; 8:45 am]
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