Document ID: FDA-2014-D-1849-0003
Agency: fda
Document Type: Notice
Title: Medical Devices and Clinical Trial Design for the Treatment or
Improvement in the Appearance of Fungally-Infected Nails; Guidance for
Industry and Food and Drug Administration Staff; Availability
Posted Date: 2016-03-07T05:00Z

[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Notices]
[Pages 11810-11811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04946]

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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; Guidance for 
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the 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 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).

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: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-D-1849 for ``Medical Devices and Clinical Trial Design for the 
Treatment or Improvement in the Appearance of Fungally-Infected 
Nails.'' Received comments will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 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.

FOR FURTHER INFORMATION CONTACT: Shlomit Halachmi, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. G439, Silver Spring, MD 20993-0002, 301-
796-6338.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry and 
FDA staff

[[Page 11811]]

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 regarding clinical 
trial design for medical devices intended either (1) to provide 
improvement in the appearance of nails affected by onychomycosis, or 
(2) to treat onychomycosis (fungal nail infection).
    In the Federal Register on January 27, 2015 (80 FR 4281), FDA 
announced the availability of the draft guidance document. Interested 
persons were invited to comment by April 27, 2015.

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 
current thinking of FDA on medical devices and clinical trial design 
for the treatment or improvement in the appearance of fungally-infected 
nails. It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the 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 807, subpart E have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 812 are approved under OMB control number 
0910-0078; the collections of information in 21 CFR part 814, subparts 
B and E are approved under OMB control number 0910-0231; the 
collections of information in 21 CFR part 814, subpart H are approved 
under OMB control number 0910-0332; 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 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)).

    Dated: March 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04946 Filed 3-4-16; 8:45 am]
 BILLING CODE 4164-01-P