[Federal Register Volume 87, Number 158 (Wednesday, August 17, 2022)]
[Rules and Regulations]
[Pages 50568-50569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17231]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 800, 801, 808, and 874

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


Regulatory Requirements for Hearing Aid Devices and Personal 
Sound Amplification Products; Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Regulatory Requirements 
for Hearing Aid Devices and Personal Sound Amplification Products.'' 
This guidance document is intended to describe hearing aids, personal 
sound amplification products (PSAPs), their respective intended uses, 
and the regulatory requirements that apply to these 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the draft guidance entitled ``Regulatory Requirements for Hearing Aid 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. This final guidance fulfills this FDARA requirement and 
supersedes ``Guidance for Industry and FDA Staff: Regulatory 
Requirements for Hearing Aid Devices and Personal Sound Amplification 
Products,'' dated February 25, 2009.

DATES: The announcement of the guidance is published in the Federal 
Register on August 17, 2022.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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.

[[Page 50569]]

    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 guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Regulatory Requirements for Hearing Aid Devices and Personal Sound 
Amplification Products'' to the Office of Policy, 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. Published elsewhere in this 
edition of the Federal Register, FDA is issuing a final rule (``rule'') 
to establish the OTC category of hearing aids and to implement the 
requirements of FDARA. In the rule, FDA has also outlined multiple 
related changes to the overall regulatory framework for hearing aids to 
harmonize existing regulations with the new OTC category while 
continuing to provide a reasonable assurance of safety and 
effectiveness.
    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 final guidance, which 
supersedes the February 25, 2009, final guidance. This final guidance 
reflects the new regulatory framework for hearing aids in the rule.
    This guidance document 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. For information on certain 
situations in which FDA does not intend to enforce certain regulatory 
requirements, you may refer to the preamble to the rule that is 
published elsewhere in this edition of the Federal Register.
    A notice of availability of the draft guidance appeared in the 
Federal Register of October 20, 2021 (86 FR 58192). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments, including aligning the guidance with the rule.
    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 ``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 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 document is also 
available at https://www.regulations.gov and 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 new 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                                        Topic                    OMB control No.
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807, subpart E.......................................  Premarket notification.................         0910-0120
814..................................................  Premarket approval.....................         0910-0231
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.
1000 through 1050....................................  Electronic Products....................         0910-0025
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    Dated: August 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17231 Filed 8-16-22; 8:45 am]
BILLING CODE 4164-01-P


