Document ID: FDA-2014-D-1849-0001
Agency: fda
Document Type: Notice
Title: 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Improvement in the Appearance of Fungally-Infected Nails; Draft
Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2015-01-27T05:00Z

[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4281-4282]
From the Federal Register Online via the Government Printing 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Improvement in the Appearance of Fungally-Infected Nails; Draft 
Guidance for Industry and Food and Drug Administration Staff; 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availability of the draft guidance entitled ``Medical Devices and 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 This draft guidance is not final nor is it in 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 27, 2015.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requests for a single hard copy of the draft guidance document entitled 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 CDRH-Guidance@fda.hhs.gov 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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