Document ID: FDA-2023-N-4372-0002
Agency: fda
Document Type: Notice
Title: Enforcement Policy for Clinical Electronic Thermometers; Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2023-11-03T04:00Z

[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