[Federal Register Volume 78, Number 216 (Thursday, November 7, 2013)]
[Notices]
[Pages 66940-66941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26691]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1295]


Regulatory Requirements for Hearing Aid Devices and Personal 
Sound Amplification Products; Draft Guidance for Industry and Food and 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availability of the draft guidance entitled ``Regulatory Requirements 
for Hearing Aid Devices and Personal Sound Amplification Products.'' 
This draft guidance clarifies the distinction between hearing aids and 
personal sound amplification products (PSAPs), as well as the 
regulatory controls that apply to each. This draft guidance is not 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 on 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 5, 2014.

[[Page 66941]]


ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Regulatory Requirements for Hearing Aid 
Devices and Personal Sound Amplification Products'' 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Eric A. Mann, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2438, Silver Spring, MD 20993-0002, 301-796-5620.

SUPPLEMENTARY INFORMATION: 

I. Background

    Since issuance of the February 25, 2009 guidance entitled, 
``Regulatory Requirements for Hearing Aid Devices and Personal Sound 
Amplification Products'' FDA has become aware of a lack of clarity 
regarding how the Agency defines a hearing aid versus a personal sound 
amplification product (PSAP), which has also led, in some cases, to 
inappropriate application of regulatory requirements for such products. 
These inconsistent interpretations of the definitions may inadvertently 
result in hearing-impaired consumers bypassing safeguards that were 
implemented to promote the prompt diagnosis of treatable medical 
conditions causing hearing loss. To ensure consistent interpretation, 
consistent application of relevant regulatory requirements, and 
adequate protection of the public health, FDA seeks to further clarify 
the definitions of hearing aids and PSAPs.
    This draft guidance, when finalized, will supersede the guidance 
entitled ``Guidance for Industry and FDA Staff: Regulatory Requirements 
for Hearing Aid Devices and Personal Sound Amplification Products,'' 
dated February 25, 2009.

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 the 
definitions and regulatory requirements for hearing aids and PSAPs. 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 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 
``Regulatory Requirements for Hearing Aid Devices and Personal Sound 
Amplification Products'' 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 1832 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft 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 801 have been approved under 
OMB control number 0910-0485; and the collections of information in 21 
CFR part 807 subpart E have been approved under OMB control number 
0910-0120.

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: November 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26691 Filed 11-6-13; 8:45 am]
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