[Federal Register Volume 88, Number 212 (Friday, November 3, 2023)]
[Notices]
[Pages 75602-75604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24290]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4372]


Medical Devices; Exemptions From Premarket Notification: Class II 
Devices; Clinical Electronic Thermometers; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has 
identified certain class II clinical electronic thermometers that, when 
finalized, will be exempt from premarket notification requirements, 
subject to certain limitations. FDA is publishing this notice of that 
determination and requesting public comment in accordance with the 
procedures established by the 21st Century Cures Act. FDA will review 
any comments submitted within the 60-day comment period and will 
consider whether any modifications should be made to the exemption for 
certain clinical electronic thermometers prior to publication of its 
final determination in the Federal Register.

DATES: Either electronic or written comments on the notice must be 
submitted by January 2, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 2, 2024. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

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 ``Medical Devices; Exemptions from Premarket 
Notification: Class II Devices; Clinical Electronic Thermometers; 
Request for Comments.'' Received comments, those filed in a timely 
manner (see ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Madhusoodana Nambiar, Center for 
Devices and Radiological Health, Food

[[Page 75603]]

and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5519, 
Silver Spring, MD 20993, 301-796-5837, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Under section 513 of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 360c), FDA must classify devices into one of three 
regulatory classes: class I, class II, or class III. FDA classification 
of a device is determined by the amount of regulation necessary to 
provide a reasonable assurance of safety and effectiveness. Under the 
Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295), 
and the amendments of the Safe Medical Devices Act of 1990 (Pub. L. 
101-629), devices are to be classified into class I (general controls) 
if there is information showing that the general controls of the FD&C 
Act are sufficient to assure safety and effectiveness; into class II 
(special controls), if general controls, by themselves, are 
insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls to provide such assurance; and into class III (premarket 
approval), if there is insufficient information to support classifying 
a device into class I or class II and the device is a life sustaining 
or life supporting device or is for a use which is of substantial 
importance in preventing impairment of human health or presents a 
potential unreasonable risk of illness or injury.
    Most generic types of devices that were on the market before the 
date of the 1976 amendments (May 28, 1976) (generally referred to as 
preamendments devices) have been classified by FDA under the procedures 
set forth in section 513(c) and (d) of the FD&C Act through the 
issuance of classification regulations into one of these three 
regulatory classes. Devices introduced into interstate commerce for the 
first time on or after May 28, 1976 (generally referred to as 
postamendments devices) are classified through the premarket 
notification process under section 510(k) of the FD&C Act (21 U.S.C. 
360(k)). Section 510(k) of the FD&C Act and the implementing 
regulations, part 807 of Title 21 of the Code of Federal Regulations 
(CFR), require persons who intend to market a new device to submit a 
premarket notification (510(k)) containing information that allows FDA 
to determine whether the new device is ``substantially equivalent'' 
within the meaning of section 513(i) of the FD&C Act to a legally 
marketed device that does not require premarket approval.
    The 21st Century Cures Act (Cures Act) (Pub. L. 114-255) was signed 
into law on December 13, 2016. Section 3054 of the Cures Act amended 
section 510(m) of the FD&C Act. As amended, section 510(m)(1)(A) of the 
FD&C Act requires FDA to publish in the Federal Register a notice 
containing a list of each type of class II device that FDA determines 
no longer requires a report under section 510(k) of the FD&C Act to 
provide reasonable assurance of safety and effectiveness. FDA is 
required to publish this notice within 90 days of the date of enactment 
of the Cures Act and at least once every 5 years thereafter, as FDA 
determines appropriate. Additionally, FDA must provide at least a 60-
day comment period for any such notice published under section 
510(m)(1)(A) of the FD&C Act.
    FDA published the initial notice within the 90-day time frame in 
the Federal Register of March 14, 2017 (82 FR 13609) and issued its 
final determination of exemption of the devices in such notice in 
accordance with section 510(m)(1)(B) of the FD&C Act in the Federal 
Register of July 11, 2017 (82 FR 31976). FDA is publishing this notice 
and requesting public comment in accordance with section 510(m)(1)(A) 
of the FD&C Act. In a future final action, and after considering 
comments, FDA intends to amend the codified language in the clinical 
electronic thermometer regulation to reflect the final determination 
with respect to exemption.

II. Factors FDA May Consider for Exemption

    There are a number of factors FDA may consider to determine whether 
a 510(k) is necessary to provide reasonable assurance of the safety and 
effectiveness of a class II device. These factors are discussed in the 
January 21, 1998, Federal Register notice (63 FR 3142) and subsequently 
in the guidance the Agency issued on February 19, 1998, entitled 
``Procedures for Class II Device Exemptions from Premarket 
Notification, Guidance for Industry and CDRH Staff'' (``Class II 510(k) 
Exemption Guidance'') (Ref. 1). Accordingly, FDA generally considers 
the following factors to determine whether premarket notification is 
necessary for class II devices: (1) the device does not have a 
significant history of false or misleading claims or of risks 
associated with inherent characteristics of the device; (2) 
characteristics of the device necessary for its safe and effective 
performance are well established; (3) changes in the device that could 
affect safety and effectiveness will either (a) be readily detectable 
by users by visual examination or other means such as routine testing, 
before causing harm, or (b) not materially increase the risk of injury, 
incorrect diagnosis, or ineffective treatment; and (4) any changes to 
the device would not be likely to result in a change in the device's 
classification. FDA may also consider that, even when exempting 
devices, these devices would still be subject to the limitations on 
exemptions.

III. Limitations on Exemptions

    FDA has determined that premarket notification is not necessary to 
provide a reasonable assurance of safety and effectiveness for certain 
class II clinical electronic thermometers subject to the limitations 
outlined in table 1. This determination is based, in part, on the 
Agency's knowledge of the device, including past experience and 
relevant reports or studies on device performance (as appropriate), the 
applicability of general and special controls, and the Agency's ability 
to limit an exemption.

A. General Limitations of Exemptions

    FDA's proposal to grant an exemption from premarket notification 
applies only to those devices that have existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type. After comment and issuance of a notice announcing 
FDA's final determination, a manufacturer of a clinical electronic 
thermometer would still be required to submit a premarket notification 
to FDA before introducing a device or delivering it for introduction 
into commercial distribution when the device meets any of the 
conditions described in Sec.  880.9 (21 CFR 880.9).

B. Partial Limitations of Exemptions

    In addition to the general limitations, FDA may also partially 
limit an exemption from premarket notification requirements to specific 
devices within a listed device type when the initial Agency assessment 
determines that the factors laid out in the Class II 510(k) Exemption 
Guidance (Ref. 1) do not weigh in favor of exemption for all devices 
within a generic type of device. In such situations where a partial 
limitation of the exemption has been identified, FDA has determined 
that premarket notification is necessary to provide a reasonable 
assurance of safety and effectiveness for devices that fall outside of 
the limitations. In table 1, for example, FDA is listing the proposed 
exemption of clinical electronic thermometers but limits the exemption

[[Page 75604]]

to devices that are appropriately tested in accordance with specific 
FDA-recognized standards (as outlined in the limitations) and excludes 
clinical electronic thermometers with telethermographic and continuous 
temperature measurement functions.
    Most contact and non-contact clinical electronic thermometers that 
are appropriately tested in accordance with specific FDA-recognized 
standards are well-understood devices; however, FDA considers premarket 
notification requirements for clinical thermometers with 
telethermographic and continuous temperature measurement functions to 
be necessary to provide a reasonable assurance of safety and 
effectiveness because such thermometers include newer technology that 
may require additional testing beyond that specified in FDA-recognized 
standards and have additional biocompatibility, interoperability, 
electromagnetic compatibility, electrical safety, and sterility 
considerations compared to clinical electronic thermometers without 
these types of functions.

IV. Class II Device

    FDA is identifying the following class II device that, if 
finalized, would no longer require premarket notification under section 
510(k) of the FD&C Act, subject to the general limitations to the 
exemptions found in Sec.  880.9:

                                            Table 1--Class II Devices
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          21 CFR  section            Device description      Product code        Partial exemption limitation
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880.2910..........................  Clinical electronic   FLL..............  Exemption is limited to the
                                     thermometer.                             following:
                                                                             1. Device is not a clinical
                                                                              thermometer with telethermography
                                                                              functions;
                                                                             2. Device is not a clinical
                                                                              thermometer with continuous
                                                                              temperature measurement functions;
                                                                              and
                                                                             3. Appropriate analysis and testing
                                                                              (such as outlined in the currently
                                                                              FDA-recognized editions of ISO
                                                                              80601-2-56 Medical electrical
                                                                              equipment--Part 2-56: Particular
                                                                              requirements for basic safety and
                                                                              essential performance of clinical
                                                                              thermometers for body temperature
                                                                              measurement, or ASTM E1965
                                                                              Standard Specification for
                                                                              Infrared Thermometers for
                                                                              Intermittent Determination of
                                                                              Patient Temperature, or ASTM E1112
                                                                              Standard Specification for
                                                                              Electronic Thermometer for
                                                                              Intermittent Determination of
                                                                              Patient Temperature, or ASTM E1104
                                                                              Standard Specification for
                                                                              Clinical Thermometer Probe Covers
                                                                              and Sheaths) must validate
                                                                              specifications and performance of
                                                                              the device.
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    FDA will assign new product codes to clinical electronic 
thermometers with telethermography functions and those with continuous 
temperature measurement functions in order to ensure that these devices 
can be identified distinctly from devices that will be exempt subject 
to the partial limitations under the existing product code (i.e., 
exempt and non-exempt devices within a device type will have different 
product codes).

V. Reference

    The following reference is on display in the Dockets Management 
Staff (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at https://www.regulations.gov. FDA has 
verified the website address, as of the date this document publishes in 
the Federal Register, but websites are subject to change over time.

    1. FDA Guidance, ``Procedures for Class II Device Exemptions 
from Premarket Notification, Guidance for Industry and CDRH Staff,'' 
February 19, 1998, available at https://www.fda.gov/media/72685/download.

    Dated: October 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24290 Filed 11-2-23; 8:45 am]
BILLING CODE 4164-01-P