Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Guidance for Industry and Food and Drug Administration Staff; Availability, 50568-50569 [2022-17231]
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50568
§ 71.1
Federal Register / Vol. 87, No. 158 / Wednesday, August 17, 2022 / Rules and Regulations
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order JO 7400.11F,
■
T–229 Fairbanks, AK (FAI) to VANTY, AK [Amended]
Fairbanks, AK (FAI)
VORTAC
(Lat. 64°48′00.25″
Tanana, AK (TAL)
VOR/DME
(Lat. 65°10′37.65″
Huslia, AK (HSL)
VOR/DME
(Lat. 65°42′28.35″
Selawik, AK (WLK)
VOR/DME
(Lat. 66°35′58.11″
Kotzebue, AK (OTZ)
VOR/DME
(Lat. 66°53′08.46″
VANTY, AK
WP
(Lat. 68°20′40.68″
*
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[FR Doc. 2022–17513 Filed 8–16–22; 8:45 am]
BILLING CODE 4910–13–P
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
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notification of availability.
AGENCY:
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draft guidance entitled ‘‘Regulatory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.
JSPEARS on DSK121TN23PROD with RULES
SUMMARY:
16:10 Aug 16, 2022
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Jkt 256001
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
PO 00000
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Fmt 4700
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166°47′53.61″
ADDRESSES:
Issued in Washington, DC, on August 10,
2022.
Scott M. Rosenbloom,
Manager, Airspace Rules and Regulations.
VerDate Sep<11>2014
Paragraph 6011 United States Area
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amended as follows:
*
*
*
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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-201509-18/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.
E:\FR\FM\17AUR1.SGM
17AUR1
Federal Register / Vol. 87, No. 158 / Wednesday, August 17, 2022 / Rules and Regulations
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: ShuChen 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-thecounter (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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-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
CDRH-Guidance@fda.hhs.gov 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:
21 CFR part
Topic
807, subpart E ....................
814 ......................................
800, 801, and 809 ..............
803 ......................................
Premarket notification ....................................................................................................................
Premarket approval ........................................................................................................................
Medical Device Labeling Regulations ............................................................................................
Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user
facility reporting, distributor reporting.
Electronic Products ........................................................................................................................
1000 through 1050 .............
OMB control No.
JSPEARS on DSK121TN23PROD with RULES
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
VerDate Sep<11>2014
16:10 Aug 16, 2022
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Fmt 4700
Sfmt 9990
50569
E:\FR\FM\17AUR1.SGM
17AUR1
0910–0120
0910–0231
0910–0485
0910–0437
0910–0025
]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
----------------------------------------------------------------------------------------------------------------
21 CFR part Topic OMB control No.
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
