[Federal Register Volume 90, Number 116 (Wednesday, June 18, 2025)]
[Rules and Regulations]
[Pages 25889-25891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-11207]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 880
[Docket No. FDA-2023-N-4372]
Medical Devices; Exemptions From Premarket Notification: Class II
Devices; Clinical Electronic Thermometers
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final Order.
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SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
publishing an order setting forth the Agency's final determination to
exempt certain class II clinical electronic thermometers from premarket
notification (510(k)) requirements, subject to certain limitations.
This exemption from 510(k), subject to certain limitations, is
immediately in effect for such class II clinical electronic
thermometers. This exemption will decrease regulatory burdens on the
medical device industry and will eliminate private costs and
expenditures required to comply with Federal regulations. FDA is
amending the classification language within the Code of Federal
Regulations for certain class II clinical electronic thermometers to
reflect this final determination. FDA is publishing this order in
accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES: This order is effective June 18, 2025.
FOR FURTHER INFORMATION CONTACT: Linh Lo, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993, 301-796-0463,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and its
implementing regulations in part 807, subpart E (21 CFR part 807,
subpart E), persons who propose to begin the introduction or delivery
for introduction into interstate commerce for commercial distribution
of a device intended for human use are required to submit a premarket
notification to FDA. The device may not be marketed until FDA finds it
``substantially equivalent'' within the meaning of section 513(i) of
the FD&C Act (21 U.S.C. 360c(i)) 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) of the
FD&C Act requires that within 90 days of the date of enactment of the
Cures Act, and at least once every 5 years thereafter (as FDA
determines appropriate), FDA 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 must
provide at least a 60-day comment period for any such notice prior to
issuing a final determination with respect to the devices contained in
the list. Additionally, section 510(m)(2) of the FD&C Act provides that
FDA may exempt a class II device from the requirement to submit a
report under section 510(k) of the FD&C Act, upon its own initiative or
a petition of an interested person, if FDA determines that a 510(k) is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device. FDA must publish in the Federal Register a
notice of intent to exempt a device, or of the petition, and provide a
60-day comment period.
In the Federal Register of November 3, 2023 (88 FR 75602), FDA
published a notice announcing its intent to exempt certain class II
clinical electronic thermometers from premarket notification (510(k))
requirements, subject to certain limitations, and provided 60 days for
interested persons to submit comments by January 2, 2024. Although FDA
received no comments to the docket following a 60-day comment period,
FDA is making minor modifications to clarify the limitations on
exemption (see section III. B. Partial Limitations of Exemptions).
Additionally, we provide examples to help clarify the first two partial
limitations of exemption (see section III. B. Partial Limitations of
Exemptions). This final order sets forth our final determination to
exempt certain class II clinical electronic thermometers that were the
subject of the notice. Through this action, FDA is now amending the
language for the identified classification regulation (21 CFR
880.2910(b)) to reflect this final determination.\1\
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\1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
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This final order is expected to result in decreased regulatory
burdens and is considered an E.O. 14192 deregulatory action.
II. Criteria for Exemption
There are a number of factors FDA may consider to determine whether
a premarket notification (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'') (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff). 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.
[[Page 25890]]
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
The exemption from premarket notification established in this order
applies only to those devices that have existing or reasonably
foreseeable characteristics of commercially distributed devices within
that generic type (see Sec. 880.9 (21 CFR 880.9)). A manufacturer of a
clinical electronic thermometer that otherwise meets the exemption
described in 21 CFR 880.2910(b) 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.
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 Agency assessment
determines that the factors laid out in the Class II 510(k) Exemption
Guidance 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.
As described in table 1, FDA is limiting the exemption for clinical
electronic thermometers to devices that have validated specifications
and performance via appropriate testing and analysis, such as analysis
and testing in accordance with FDA-recognized editions of standards as
appropriate. We added ``as appropriate'' to the third limitation in the
codified language because a combination of standards may be necessary
to fully assess the device. We recommend that manufacturers use the
recognized consensus standards database for medical devices (available
at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/Search.cfm) to determine the FDA-recognized standards and versions
appropriate to their device by searching for the relevant product code.
This order also excludes clinical electronic thermometers with
telethermographic functions and continuous temperature measurement
functions from the exemption from premarket notification. Examples of
clinical electronic thermometers with telethermographic functions
include a kiosk with integrated infrared thermometer, a stationary
infrared thermometer affixed to a wall or ceiling, or a wheeled cart
with integrated infrared thermometry function. Examples of thermometers
with continuous temperature measurement functions include temperature
probes intended to monitor body temperature during surgical procedures,
temperature probes affixed to the skin of neonates or infants intended
to monitor body temperature, thermometer patches affixed to the
patient's skin, or thermometers that are swallowed to monitor a
patient's body temperature. FDA considers premarket notification
requirements for infrared clinical electronic thermometers with
telethermographic functions and clinical electronic thermometers with
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.
For example, an infrared thermometer kiosk is used as a stationary
device, has a camera that captures a person's face, and uses a single
infrared sensor. These technological characteristics necessitate
additional testing beyond those specified in FDA-recognized standards
to provide a reasonable assurance of safety and effectiveness.
IV. Class II Device
FDA is identifying the following class II device that will 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 and any partial exemption limitations identified in Table
1.
Table 1--Class II Devices
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Device Exempt product Non-exempt Partial exemption limitation
21 CFR section description code product code (as applicable)
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880.2910.............. Clinical SDV.............. Not applicable... Exemption is limited to the
Electronic following:
Thermometer. 1. Device is not a clinical
thermometer with
telethermographic functions;
2. Device is not a clinical
thermometer with continuous
temperature measurement
functions; and
3. Appropriate analysis and
testing (such as that outlined
in the currently FDA-
recognized editions, as
appropriate, 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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To reduce administrative burden, FDA has assigned new product codes
to clinical thermometers with telethermographic functions, product code
SDW, and to the exempt clinical electronic thermometers, product code
[[Page 25891]]
SDV. New product code SDW, which represents clinical electronic
thermometers with telethermographic functions, has been named
``Stationary Infrared Thermometer.'' Clinical electronic thermometers
with continuous temperature measurement functions continue to fall
under product code FLL. As such, FDA has revised the name of product
code FLL from ``Thermometer, Electronic, Clinical'' to ``Continuous
Measurement Thermometer'' to more accurately reflect the devices that
fall within this product code. New product code SDV, which represents
the class II exempt clinical electronic thermometers and reflects the
partial exemption limitations, has been named ``Clinical Electronic
Thermometer.'' This ensures that the non-exempt devices can be
identified distinctly from devices that fall within the partial
exemption limitation (i.e., exempt and non-exempt devices have distinct
product codes).
V. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VI. Paperwork Reduction Act of 1995
FDA concludes that this final order contains no new collection of
information. This final order refers to previously approved collections
of information. These collections of information are subject to review
by the OMB under the PRA. The collections of information in part 807,
subpart E, regarding premarket notification submissions have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR parts 800, 801, and 830, regarding labeling have
been approved under OMB control number 0910-0485; and the collections
of information in 21 CFR part 820 regarding quality system regulation
have been approved under OMB control number 0910-0073.
List of Subjects in 21 CFR Part 880
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
880 is amended as follows:
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
0
1. The authority citation for part 880 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. In Sec. 880.2910, revise paragraph (b) to read as follows:
Sec. 880.2910 Clinical electronic thermometer.
* * * * *
(b) Classification. Class II (performance standards). The device is
exempt from the premarket notification procedures in part 807, subpart
E of this chapter, subject to the limitations in Sec. 880.9 and the
following conditions for exemption:
(1) Device is not a clinical thermometer with telethermographic
functions;
(2) Device is not a clinical thermometer with continuous
temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the
currently FDA-recognized editions, as appropriate, 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.
Dated: June 13, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11207 Filed 6-17-25; 8:45 am]
BILLING CODE 4164-01-P