Notice2022-24707
Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
November 14, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled "Referencing the Definition of `Device' in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents." FDA is issuing this guidance to promote clarity regarding references to the terms "device" and "counterfeit device" in guidance, regulatory documents, communications, and other public documents.
Full Text
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<title>Federal Register, Volume 87 Issue 218 (Monday, November 14, 2022)</title>
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[Federal Register Volume 87, Number 218 (Monday, November 14, 2022)]
[Notices]
[Pages 68179-68180]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-24707]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0997]
Referencing the Definition of ``Device'' in the Federal Food,
Drug, and Cosmetic Act in Guidance, Regulatory Documents,
Communications, and Other Public Documents; Guidance for Industry and
Food and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a final guidance entitled ``Referencing
the Definition of `Device' in the Federal Food, Drug, and Cosmetic Act
in Guidance, Regulatory Documents, Communications, and Other Public
Documents.'' FDA is issuing this guidance to promote clarity regarding
references to the terms ``device'' and ``counterfeit device'' in
guidance, regulatory documents, communications, and other public
documents.
DATES: The announcement of the guidance is published in the Federal
Register on November 14, 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:
<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-2021-D-0997 for ``Referencing the Definition of `Device' in the
Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents,
Communications, and Other Public
[[Page 68180]]
Documents.'' 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 guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Referencing the Definition of `Device' in the Federal Food, Drug, and
Cosmetic Act in Guidance, Regulatory Documents, Communications, and
Other Public Documents'' 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: Eli Tomar, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5462, Silver Spring, MD 20993-0002, 301-796-0699;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
For many years, the definition of ``device'' has been codified at
section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 321(h)). As a result of the enactment of the Safeguarding
Therapeutics Act (Pub. L. 116-304), the definition of ``device'' was
redesignated as subsection (h)(1) and a new definition of ``counterfeit
device'' was codified at subsection (h)(2) of section 201 of the FD&C
Act.
FDA is issuing this final guidance to clarify how the Agency
intends to interpret existing references to section 201(h) of the FD&C
Act and how we intend to reference the definitions of ``device'' and
``counterfeit device'' going forward. This guidance is intended to
provide clarity on references to the terms ``device'' and ``counterfeit
device''--as well as references to section 201(h) of the FD&C Act--in
guidance, regulatory documents, and other communications and documents
for FDA staff, industry, and other stakeholders. To minimize the
potential for miscommunication, FDA also encourage stakeholders, to the
extent practicable, to align with the conventions described in the
guidance.
A notice of availability of the draft guidance appeared in the
Federal Register of December 16, 2021 (86 FR 71507). FDA considered
comments received and revised the guidance to improve clarity,
including adding examples of how the policy in the guidance should be
applied.
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 ``Referencing the Definition of `Device' in
the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory
Documents, Communications, and Other Public Documents.'' 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 <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 document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</a>. Persons unable to download an electronic copy of
``Referencing the Definition of `Device' in the Federal Food, Drug, and
Cosmetic Act in Guidance, Regulatory Documents, Communications, and
Other Public Documents'' may send an email request to <a href="/cdn-cgi/l/email-protection#30737462781d77455954515e5355705654511e5858431e575f46"><span class="__cf_email__" data-cfemail="71323523395c36041815101f1214311715105f1919025f161e07">[email protected]</span></a> to receive an electronic copy of the document.
Please use the document number 21008 and complete title to identify the
guidance you are requesting.
III. Paperwork Reduction Act of 1995
FDA concludes that this guidance contains no collection of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.
Dated: November 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24707 Filed 11-10-22; 8:45 am]
BILLING CODE 4164-01-P
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