[Federal Register Volume 86, Number 200 (Wednesday, October 20, 2021)]
[Notices]
[Pages 58192-58193]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22612]



  Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / 
Notices  

[[Page 58192]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1380]


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Sound Amplification Products; Draft Guidance for Industry and Food and 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, Health and Human Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Regulatory 
Requirements for Hearing Aid Devices and Personal Sound Amplification 
Products.'' The FDA Reauthorization Act of 2017 (FDARA) directed FDA to 
update and finalize the draft guidance entitled ``Regulatory 
Requirements for Hearing Aid Devices and Personal Sound Amplification 
Products,'' issued on November 7, 2013. Therefore, FDA is issuing this 
updated draft guidance, which supersedes the November 7, 2013, draft 
guidance. This updated draft guidance is intended to describe hearing 
aids, personal sound amplification products (PSAPs), their respective 
intended uses, and the regulatory requirements that apply to these 
products. This draft guidance is not final nor is it in effect at this 
time.

DATES: Submit either electronic or written comments on the draft 
guidance by January 18, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2020-D-1380 for ``Regulatory Requirements for Hearing Aid Devices 
and Personal Sound Amplification Products.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 draft guidance. Submit 
written requests for a single hard copy of the draft guidance document 
entitled ``Regulatory Requirements for Hearing Aid Devices and Personal 
Sound Amplification Products'' to the Office of Policy, 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: Shu-Chen Peng, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1224, Silver Spring, MD 20993-0002, 301-796-6481.

SUPPLEMENTARY INFORMATION:

I. Background

    The FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52) 
directs FDA to establish a category of over-the-counter (OTC) hearing 
aids through rulemaking, and mandates that FDA establish various 
requirements for this category of devices. FDA has issued a proposed 
rule to establish the OTC category of hearing aids and to implement the 
requirements of FDARA (``Proposed Rule'') as published elsewhere in 
this edition of the Federal Register. In the proposed rule, FDA has 
also proposed multiple related changes to the overall regulatory 
framework for hearing aids to harmonize existing regulations with the 
proposed OTC category while continuing to provide a reasonable 
assurance of safety and effectiveness.

[[Page 58193]]

    FDARA also directed FDA to update and finalize the draft guidance 
entitled ``Regulatory Requirements for Hearing Aid Devices and Personal 
Sound Amplification Products,'' issued on November 7, 2013. To fulfill 
this requirement of FDARA, FDA is issuing this updated draft guidance, 
which supersedes the November 7, 2013, draft guidance. This updated 
draft guidance reflects the current regulatory framework for hearing 
aids and summarizes the new regulatory framework for hearing aids in 
the proposed rule. After the proposed rule is finalized, this guidance 
will be updated accordingly so that it only reflects the final 
regulatory framework for hearing aids.
    This guidance identifies current applicable legal requirements 
under the Federal Food, Drug, and Cosmetic Act for hearing aids and for 
PSAPs. This guidance is intended to describe hearing aids, PSAPs, their 
respective intended uses, and the regulatory requirements that apply to 
both types of products.
    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 current thinking of FDA on ``Regulatory 
Requirements for Hearing Aid Devices and Personal Sound Amplification 
Products.'' 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.

II. 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 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance is also 
available at https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Regulatory Requirements for Hearing 
Aid Devices and Personal Sound Amplification Products'' may send an 
email request to [email protected] to receive an electronic 
copy of the document. Please use the document number 1832 and complete 
title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations have been approved by 
OMB as listed in the following table:

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                    21 CFR part(s)                                      Topic                    OMB control No.
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800, 801, and 809....................................  Medical Device Labeling Regulations....         0910-0485
803..................................................  Medical Devices; Medical Device                 0910-0437
                                                        Reporting; Manufacturer reporting,
                                                        importer reporting, user facility
                                                        reporting, distributor reporting.
807, subpart E.......................................  Premarket notification.................         0910-0120
814..................................................  Premarket Approval Application.........         0910-0231
1000 through 1050....................................  Electronic Products....................         0910-0025
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    This draft guidance also refers to proposed collections of 
information described in FDA's proposed rule on ``Medical Devices; Ear, 
Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids.'' 
The proposed collections of information in the proposed rule are 
subject to review by OMB under the PRA (44 U.S.C. 3501-3521). As 
required by the PRA, FDA has published an analysis of the information 
collection provisions of the proposed rule as published elsewhere in 
this edition of the Federal Register and has submitted it for OMB 
approval.

    Dated: October 12, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22612 Filed 10-19-21; 8:45 am]
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