Rule2026-08425
Medical Devices; Neurological Devices; Classification of the Brain Temperature Measurement System
Primary source
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Published
April 30, 2026
Effective
April 30, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the brain temperature measurement system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the brain temperature measurement system. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Full Text
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<title>Federal Register, Volume 91 Issue 83 (Thursday, April 30, 2026)</title>
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[Federal Register Volume 91, Number 83 (Thursday, April 30, 2026)]
[Rules and Regulations]
[Pages 23163-23166]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-08425]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA-2026-N-4269]
Medical Devices; Neurological Devices; Classification of the
Brain Temperature Measurement System
AGENCY: Food and Drug Administration, HHS.
[[Page 23164]]
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
brain temperature measurement system into class II (special controls).
The special controls that apply to the device type are identified in
this order and will be part of the codified language for classification
of the brain temperature measurement system. We are taking this action
because we have determined that classifying the device into class II
will provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices, in part by reducing regulatory burdens.
DATES: This order is effective April 30, 2026. The classification was
applicable on March 29, 2022.
FOR FURTHER INFORMATION CONTACT: Jay Gupta, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4234, Silver Spring, MD 20993-0002, 301-796-2795,
<a href="/cdn-cgi/l/email-protection#fbb19a82d5bc8e8b8f9abb9d9f9ad5939388d59c948d"><span class="__cf_email__" data-cfemail="276d465e09605257534667414346094f4f5409404851">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the brain
temperature measurement system into class II (special controls), which
we have determined will provide a reasonable assurance of safety and
effectiveness of the device. In addition, we believe this action will
enhance patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified into, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate device by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)).
Section 207 of the Food and Drug Administration Modernization Act of
1997 (Pub. L. 105-115) established the first procedure for De Novo
classification. Section 607 of the Food and Drug Administration Safety
and Innovation Act (Pub. L. 112-144) modified the De Novo
classification process by adding a second procedure. A device sponsor
may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a premarket
notification (510(k)) for a device that has not previously been
classified. After receiving an order from FDA classifying the device
into class III under section 513(f)(1) of the FD&C Act, the person then
requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the
FD&C Act). As a result, other device sponsors do not have to submit a
De Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less burdensome 510(k) process, when necessary, to market their device.
II. De Novo Classification
On June 26, 2020, FDA received BrainTemp, Inc.'s request for De
Novo classification of the BrainTemp Neonate (BTNeo) System. FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness of the device, but there is sufficient information to
establish special controls that, in combination with the general
controls, provide reasonable assurance of the safety and effectiveness
of the device for its intended use (see section 513(a)(1)(B) of the
FD&C Act). After review of the information submitted in the request, we
determined that the device can be classified into class II with the
establishment of special controls. FDA has determined that these
special controls, in addition to the general controls, will provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, on March 29, 2022, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
882.1565.\1\ We have named the generic type of device ``brain
temperature measurement system,'' and it is identified as an externally
placed, prescription device intended to measure brain temperature.
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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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FDA has identified the risks to health associated with this type of
device and the measures required to mitigate these risks in table 1.
[[Page 23165]]
Table 1--Risks to Health and Mitigation Measures for Brain Temperature
Measurement System
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Identified risks to health Mitigation measures
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Inaccurate measurement made by the In vivo performance testing;
device, resulting in misuse or Non-clinical performance
misinterpretation of device output. testing; Software
verification, validation, and
hazard analysis; Usability
evaluation; and Labeling.
Equipment malfunction leading to injury Electrical, mechanical, and
to user/patient (e.g., shock, burn, thermal safety testing;
interference). Electromagnetic compatibility
testing; and Labeling.
Adverse tissue reaction, including Biocompatibility evaluation;
thermal or pressure injuries. Usability evaluation; and
Labeling.
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FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness of the device. For a device to
fall within this classification, and thus avoid automatic
classification in class III, it would have to comply with the special
controls named in this final order. The necessary special controls
appear in the regulation codified by this final order.
At the time of classification, brain temperature measurement
systems are for prescription use only. Prescription devices are exempt
from the requirement for adequate directions for use for the layperson
under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21
CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.
Under the FD&C Act, submission of a premarket notification under
section 510(k) is required to reasonably assure the safety and
effectiveness of class II devices unless FDA determines that the device
type should be exempt under section 510(m) of the FD&C Act. At this
time FDA has not made this determination for brain temperature
measurement systems. This device is therefore subject to premarket
notification requirements under section 510(k) of the FD&C Act.
III. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not normally have a significant effect on the human
environment. Therefore, neither an environmental assessment nor an
environmental impact statement is required.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in part 860, subpart D, regarding De Novo classification
have been approved under OMB control number 0910-0844; the collections
of information in 21 CFR part 814, subparts A through E, regarding
premarket approval have been approved under OMB control number 0910-
0231; 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 part 820
regarding quality management system regulation have been approved under
OMB control number 0910-0073; and the collections of information in 21
CFR part 801 regarding labeling have been approved under OMB control
number 0910-0485.
List of Subjects in 21 CFR Part 882
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
882 is amended as follows:
PART 882--NEUROLOGICAL DEVICES
0
1. The authority citation for part 882 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 882.1565 to subpart B to read as follows:
Sec. 882.1565 Brain temperature measurement system.
(a) Identification. A brain temperature measurement system is an
externally placed, prescription device intended to measure brain
temperature.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) In vivo performance testing must demonstrate that the device
performs as intended for its anticipated conditions of use and can
accurately and reliably measure brain temperature compared to a ground
truth measurement.
(2) Non-clinical performance testing must demonstrate that the
device can accurately measure changes in brain temperature under
simulated conditions of use. Testing must assess repeatability within
pre- specified, clinically relevant parameters. The technical
specifications of the device's hardware and software must be fully
characterized.
(3) Electrical safety, thermal safety, mechanical safety, and
electromagnetic compatibility testing must be performed.
(4) Software documentation must include a detailed technical
description of the algorithm(s) used to generate the device output(s),
and be accompanied by verification and validation testing to ensure
device and algorithm functionality as informed by the software
requirements and hazard analysis.
(5) The tissue contacting device components must be demonstrated to
be biocompatible.
(6) Usability evaluation must demonstrate that the intended user(s)
can safely and correctly use the device, based solely on reading the
directions for use.
(7) Labeling must include:
(i) Instructions for use, including a detailed description of the
device and explanation of all device outputs.
(ii) The following warnings:
(A) A statement that the device is not intended to measure core
body temperature, and to use an independent thermometer to measure core
body temperature.
(B) Conditions of use that may impact the accuracy and reliability
of the device measurement.
(C) Conditions of use that may affect skin integrity or cause skin
injury, such as extended wear duration or placement of the device on
damaged or compromised skin, skin lesions, or open wounds.
(D) Limitations of device use to inform diagnosis or therapy.
(E) Summaries of in vivo testing conducted to demonstrate how the
device functions as intended.
(F) The summary must include the following:
(G) A description of each device output.
(H) A description of the study population and the use environment.
(I) The methods used to collect temperature data.
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(J) Any observed adverse events and complications.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-08425 Filed 4-29-26; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on April 30, 2026.
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