Notice2021-22612
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
October 20, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.'' The FDA Reauthorization Act of 2017 (FDARA) directed FDA to update and finalize the draft guidance entitled ``Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products,'' issued on November 7, 2013. Therefore, FDA is issuing this updated draft guidance, which supersedes the November 7, 2013, draft guidance. This updated draft guidance is intended to describe hearing aids, personal sound amplification products (PSAPs), their respective intended uses, and the regulatory requirements that apply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 This draft guidance is not final nor is it in effect at this time.
Full Text
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<title>Federal Register, Volume 86 Issue 200 (Wednesday, October 20, 2021)</title>
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[Federal Register Volume 86, Number 200 (Wednesday, October 20, 2021)]
[Notices]
[Pages 58192-58193]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Sound Amplification Products; Draft Guidance for Industry and Food and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the availability of the draft guidance entitled ``Regulatory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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> and at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. 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 <a href="/cdn-cgi/l/email-protection#80c3c4d2c8adc7f5e9e4e1eee3e5c0e6e4e1aee8e8f3aee7eff6"><span class="__cf_email__" data-cfemail="baf9fee8f297fdcfd3dedbd4d9dffadcdedb94d2d2c994ddd5cc">[email protected]</span></a> 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.
----------------------------------------------------------------------------------------------------------------
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]
BILLING CODE 4164-01-P
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