[Federal Register Volume 88, Number 212 (Friday, November 3, 2023)]
[Notices]
[Pages 75600-75602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24291]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4372]
Enforcement Policy for Clinical Electronic Thermometers; 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 ``Enforcement
Policy for Clinical Electronic Thermometers.'' This guidance applies to
clinical electronic thermometers, which are regulated as class II
devices. This guidance has been implemented without prior comment, but
it remains subject to comment in accordance with the Agency's good
guidance practices.
DATES: The announcement of the guidance is published in the Federal
Register on November 3, 2023.
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-2023-N-4372 for ``Enforcement Policy for Clinical Electronic
Thermometers.'' 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
[[Page 75601]]
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 Sec.
10.115(g)(5) (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
``Enforcement Policy for Clinical Electronic Thermometers'' 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: David Wolloscheck, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2416, Silver Spring, MD 20993-0002, 301-
796-1480.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a final guidance entitled
``Enforcement Policy for Clinical Electronic Thermometers.'' During the
Coronavirus Disease 2019 (COVID-19) public health emergency (PHE), FDA
issued certain enforcement policies for non-invasive remote monitoring
devices and clinical electronic thermometers. The policies regarding
the modification of previously FDA-cleared clinical electronic
thermometers within product code FLL were originally included in FDA's
guidance ``Enforcement Policy for Non-Invasive Remote Monitoring
Devices Used to Support Patient Monitoring During the Coronavirus
Disease 2019 (COVID-19) Public Health Emergency'' first issued in March
2020, and subsequently revised in June 2020, October 2020, and March
2023. The policies regarding the distribution and use of clinical
electronic thermometers not previously cleared under section 510(k) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(k))
were outlined in FDA's guidance ``Enforcement Policy for Clinical
Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19)
Public Health Emergency'' issued in April 2020 and revised in March
2023.
At the time, FDA stated that the policies described in these
guidances were intended to remain in effect only for the duration of
the PHE related to COVID-19 declared by the Secretary of Health and
Human Services in accordance with section 319 of the Public Health
Service Act (42 U.S.C. 247d). On March 13, 2023, FDA announced in the
Federal Register notice ``Guidance Documents Related to Coronavirus
Disease 2019 (COVID-19)'' (88 FR 15417) that these guidance documents
were being revised to continue in effect for 180 days after the
expiration of the COVID-19 PHE declaration, and that, during that time,
FDA would further revise these guidances, among others. Consistent with
what we said in the Federal Register notice of March 13, 2023, FDA has
revised and consolidated the policies that apply to clinical electronic
thermometers in this guidance. Elsewhere in this issue of the Federal
Register, FDA is proposing to exempt certain clinical electronic
thermometers--specifically clinical thermometers without
telethermography or continuous temperature measurement functions--from
premarket notification requirements under section 510(m) of the FD&C
Act (see the Federal Register document ``Medical Devices; Exemptions
from Premarket Notification: Class II Devices; Clinical Electronic
Thermometers; Request for Comments''). FDA intends to withdraw this
guidance after any final exemption document has been published in the
Federal Register.
The policies outlined in this guidance are organized by clinical
thermometer type. The guidance describes enforcement policies that are
intended to help foster compliance with certain applicable legal
requirements for these devices.
The enforcement policies in this guidance apply to clinical
electronic thermometers, which are regulated as class II devices under
21 CFR 880.2910, product code FLL. These devices include both contact
and non-contact clinical electronic thermometers. This guidance
supersedes ``Enforcement Policy for Clinical Electronic Thermometers
During the Coronavirus Disease 2019 (COVID-19) Public Health
Emergency'' issued in April 2020 and updated in March 2023.
This guidance is being implemented without prior public comment
because FDA has determined that prior public participation for this
guidance is not feasible or appropriate (see section 701(h)(1)(C) of
the FD&C Act (21 U.S.C. 371(h)(1)(C)) and Sec. 10.115(g)(2)). FDA has
determined that this guidance document presents a less burdensome
policy that is consistent with public health. Although this policy is
being implemented immediately without prior comment, it remains subject
to comment in accordance with FDA's good guidance practices regulation
(Sec. 10.115(g)(3)(D)). FDA will consider all comments received and
revise the guidance document as appropriate.
This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec. 10.115). The guidance represents the
current thinking of FDA on ``Enforcement Policy for Clinical Electronic
Thermometers.'' 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 or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Enforcement Policy for Clinical
Electronic Thermometers'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number GUI00020021 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. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in the following table have been approved by OMB:
[[Page 75602]]
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OMB control
21 CFR part; guidance; or FDA form Topic No.
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807, subpart E.................... Premarket 0910-0120
notification.
``Requests for Feedback and Q-Submissions and 0910-0756
Meetings for Medical Device Early Payor
Submissions: The Q-Submission Feedback Request
Program''. Programs for
Medical Devices.
800, 801, 809, and 830............ Medical Device 0910-0485
Labeling
Requirements;
Unique Device
Identification.
806............................... Medical Devices; 0910-0359
Reports of
Corrections and
Removals.
807, subparts A through D......... Medical Device 0910-0625
Registration and
Listing.
820............................... Current Good 0910-0073
Manufacturing
Practice, Quality
Systems.
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Dated: October 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24291 Filed 11-2-23; 8:45 am]
BILLING CODE 4164-01-P