Notice2023-24290
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometers; Request for Comments
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Published
November 3, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 212 (Friday, November 3, 2023)</title>
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[Federal Register Volume 88, Number 212 (Friday, November 3, 2023)]
[Notices]
[Pages 75602-75604]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<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-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
<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.
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,
<a href="/cdn-cgi/l/email-protection#b5f8d4d1ddc0c6dadad1d4dbd49bfbd4d8d7dcd4c7f5d3d1d49bddddc69bd2dac3"><span class="__cf_email__" data-cfemail="fab79b9e928f8995959e9b949bd4b49b9798939b88ba9c9e9bd4929289d49d958c">[email protected]</span></a>.
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
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.fda.gov/media/72685/download">https://www.fda.gov/media/72685/download</a>.
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
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