Rule2026-18430
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease
Primary source
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Published
September 10, 2026
Effective
September 10, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease 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 anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the 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 174 (Thursday, September 10, 2026)</title>
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[Federal Register Volume 91, Number 174 (Thursday, September 10, 2026)]
[Rules and Regulations]
[Pages 57493-57495]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18430]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
[Docket No. FDA-2026-N-9911]
Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Classification of the Anti-Tumor Necrosis Factor Alpha
Monoclonal Antibody Test System for Inflammatory Bowel Disease
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
anti-tumor necrosis factor alpha monoclonal antibody test system for
inflammatory bowel disease 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
[[Page 57494]]
classification of the anti-tumor necrosis factor alpha monoclonal
antibody test system for inflammatory bowel disease. We are taking this
action because we have determined that classifying the device into
class II will provide a reasonable assurance of the 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 September 10, 2026. The classification
was applicable on September 29, 2023.
FOR FURTHER INFORMATION CONTACT: Simona Puiu, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3564, Silver Spring, MD 20993-0002, 240-402-4940,
<a href="/cdn-cgi/l/email-protection#b5e6dcd8dadbd49be5c0dcc0f5d3d1d49bddddc69bd2dac3"><span class="__cf_email__" data-cfemail="fba8929694959ad5ab8e928ebb9d9f9ad5939388d59c948d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the anti-tumor
necrosis factor alpha monoclonal antibody test system for inflammatory
bowel disease into class II (special controls), which we have
determined will provide a reasonable assurance of the 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 December 8, 2021, FDA received ProciseDx, Inc.'s request for De
Novo classification of the Procise IFX device. On April 4, 2022, FDA
received ProciseDx, Inc.'s request for De Novo classification of the
Procise ADL device. FDA reviewed both requests in order to classify the
devices 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 the 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 requests,
we determined that the devices 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 devices.
Therefore, on September 29, 2023, FDA issued orders to the
requester classifying both devices into class II. In this final order,
FDA is codifying the classification of the devices by adding 21 CFR
862.3115.\1\ We have named the generic type of device ``anti-tumor
necrosis factor alpha monoclonal antibody test system for inflammatory
bowel disease,'' and it is identified as an in vitro diagnostic device
intended for the measurement of an anti-tumor necrosis factor alpha
monoclonal antibody as an aid in the management of patients with
Crohn's disease or ulcerative colitis.
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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 57495]]
Table 1--Risks to Health and Mitigation Measures for Anti-Tumor Necrosis
Factor Alpha Monoclonal Antibody Test Systems for Inflammatory Bowel
Disease
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Identified risks to health Mitigation measures
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Incorrect test results............ Certain design verification and
validation activities and
documentation, including certain
studies. Certain labeling
information, including certain
limiting statements.
Incorrect interpretation of test Certain design verification and
results. validation activities and
documentation, including certain
studies. Certain labeling
information, including certain
limiting statements.
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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 the 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.
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 anti-tumor necrosis factor
alpha monoclonal antibody test systems for inflammatory bowel disease.
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 parts 801 and 809 regarding labeling have been approved under OMB
control number 0910-0485.
List of Subjects in 21 CFR Part 862
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
862 is amended as follows:
PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
0
1. The authority citation for part 862 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 862.3115 to subpart D to read as follows:
Sec. 862.3115 Anti-tumor necrosis factor alpha monoclonal antibody
test system for inflammatory bowel disease.
(a) Identification. An anti-tumor necrosis factor alpha monoclonal
antibody test system is an in vitro diagnostic device intended for the
measurement of an anti-tumor necrosis factor alpha monoclonal antibody
as an aid in the management of patients with Crohn's disease or
ulcerative colitis.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Design verification and validation must include the following:
(i) Detailed documentation of studies that demonstrate the
analytical performance of the device for its intended use, including
for each analyte and device output. These studies must demonstrate
analytical performance for each monoclonal antibody analyte and device
output that is adequate to support all intended clinical uses,
including all of its indications for use, and testing environments.
These studies must include precision, reproducibility, linearity,
accuracy, high dose hook effect, sample stability, detection limits
(including limit of blank, limit of detection, and limit of
quantification) and analytical specificity studies, or alternative
approaches determined to be appropriate by FDA.
(ii) Detailed documentation of data that is adequate to support the
accuracy of the device and/or device performance for all intended
clinical uses, including all of its indications for use, as determined
to be appropriate by FDA.
(iii) Detailed documentation demonstrating traceability of the
device to an internationally recognized reference material, as
determined to be appropriate by FDA.
(2) The labeling required under Sec. 809.10(b) of this chapter
must include limiting statements including the following:
(i) The device should not be used for conditions other than Crohn's
disease or ulcerative colitis.
(ii) The test result is intended as an aid in the management of the
patient, and not to be used to replace clinical judgment.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-18430 Filed 9-9-26; 8:45 am]
BILLING CODE 4164-01-P
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