Rule2026-10905
Medical Devices; Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiology
Primary source
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Published
June 1, 2026
Effective
June 1, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the adjunctive pain measurement device for anesthesiology 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 adjunctive pain measurement device for anesthesiology. 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 104 (Monday, June 1, 2026)</title>
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[Federal Register Volume 91, Number 104 (Monday, June 1, 2026)]
[Rules and Regulations]
[Pages 32340-32343]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10905]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 868
[Docket No. FDA-2026-N-5825]
Medical Devices; Anesthesiology Devices; Classification of the
Adjunctive Pain Measurement Device for Anesthesiology
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
adjunctive pain measurement device for anesthesiology 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 adjunctive pain measurement device for
anesthesiology. 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 June 1, 2026. The classification was
applicable on February 17, 2023.
[[Page 32341]]
FOR FURTHER INFORMATION CONTACT: Neel Patel, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1232, Silver Spring, MD 20993-0002, 301-796-6274,
<a href="/cdn-cgi/l/email-protection#8ec0ebebe2a0deeffaebe2cee8eaefa0e6e6fda0e9e1f8"><span class="__cf_email__" data-cfemail="f8b69d9d94d6a8998c9d94b89e9c99d690908bd69f978e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the adjunctive
pain measurement device for anesthesiology 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 4, 2021, FDA received Medasense Biometrics Ltd.'s request
for De Novo classification of the PMD-200 device. 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 February 17, 2023, 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
868.2200.\1\ We have named the generic type of device ``adjunctive pain
measurement device for anesthesiology,'' and it is identified as a
prescription device that includes software algorithms to analyze
physiological sensor data and measure response to painful stimuli in
patients under general anesthesia. The device may be software-only or
it may include hardware such as physiological sensors. This device type
is intended for adjunctive use to tailor analgesic administration to a
patient's actual response to painful stimuli and is not intended to
independently direct decision-making.
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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 32342]]
Table 1--Risks to Health and Mitigation Measures for Adjunctive Pain
Measurement Devices for Anesthesiology
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identified risks to health Mitigation measures
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Delayed or incorrect treatment due to Clinical performance testing;
erroneous device output resulting from Non-clinical performance
software malfunction or algorithm testing; Software
error. verification, validation, and
hazard analysis; and Labeling.
Delayed or incorrect treatment due to Usability assessment; and
user misinterpretation or overreliance Labeling.
on indicator.
Adverse tissue reaction................ Biocompatibility evaluation.
Electric shock/electromagnetic Electrical safety testing; and
interference related to hardware. Electromagnetic compatibility
testing.
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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, adjunctive pain measurement devices
for anesthesiology 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 adjunctive pain
measurement devices for anesthesiology. 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 868
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
868 is amended as follows:
PART 868--ANESTHESIOLOGY DEVICES
0
1. The authority citation for part 868 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 868.2200 to subpart C to read as follows:
Sec. 868.2200 Adjunctive pain measurement device for anesthesiology.
(a) Identification. An adjunctive pain measurement device for
anesthesiology is a prescription device that includes software
algorithms to analyze physiological sensor data and measure response to
painful stimuli in patients under general anesthesia. The device may be
software-only or it may include hardware such as physiological sensors.
This device type is intended for adjunctive use to tailor analgesic
administration to a patient's actual response to painful stimuli and is
not intended to independently direct decision-making.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical data must be provided to validate the algorithm in
support of the intended use and include the following:
(i) Comparison of output measure(s) to a reference method to
demonstrate the required accuracy and/or sensitivity and specificity of
the output measure(s);
(ii) Demonstration of the consistency of the output and
representativeness of the range of data sources and data quality likely
to be encountered in the intended use population and relevant use
conditions in the intended use environment;
(iii) Evaluation of the type of pain (e.g., nociceptive, somatic,
visceral, neuropathic) that is within the scope of the indicated use;
and
(iv) For devices using algorithms based on machine learning, the
clinical validation must be completed using a dataset that is separate
from the training dataset.
(2) Software description, verification, and validation based on
comprehensive hazard analysis must be performed. Software documentation
must include:
(i) Full characterization of technical parameters of the software,
including any algorithm(s);
(ii) Description of mechanisms for handling of noisy or missing
data and poor signal quality under expected conditions of use;
(iii) Specification of acceptable incoming sensor data quality
control measures;
(iv) Mitigation of impact of user error or failure of any subsystem
components (signal detection and analysis, data display, and storage)
on output accuracy; and
(v) Justification for the validity of the algorithm(s) (e.g.,
clinical relevance of decision threshold).
(3) Non-clinical performance data must demonstrate that the device
performs as intended under anticipated conditions of use. Performance
testing under anticipated conditions of use must demonstrate the
ability of the
[[Page 32343]]
device software/algorithm to detect adequate input signal quality and
handle noisy or missing data and poor signal quality.
(4) Usability assessment must be provided to mitigate the risk of
misinterpretation of device output.
(5) The patient contacting components of the device must be
demonstrated to be biocompatible.
(6) Performance testing must demonstrate the electromagnetic
compatibility and electrical safety of any hardware components of the
device.
(7) Labeling must include the following:
(i) A summary of the clinical validation data, including
demographics and other relevant characteristics of the clinical study
participants (including age, sex, race or ethnicity, and patient
condition), the anesthetic regimen (including types (e.g., morphine,
hydromorphone, fentanyl) and doses of pain medication used), a summary
of results, and information on subpopulations (age, sex, race, or
ethnicity) that may experience disparate performance.
(ii) A description of what the device measures and outputs to the
user.
(iii) The type of sensor data used, including specification of
compatible sensors for data acquisition.
(iv) Warnings identifying sensor signal-acquisition factors that
may impact output.
(v) Warnings to identify and avoid specific patient conditions or
concomitant medical therapies that could mask pain or negatively impact
device performance leading to inaccurate measurements.
(8) Recommendations for clinical interpretation of the output,
including warning(s) emphasizing the adjunctive use of the output
measure(s).
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-10905 Filed 5-29-26; 8:45 am]
BILLING CODE 4164-01-P
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