Rule2025-09776
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Mullerian Hormone Test System
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 30, 2025
Effective
May 30, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is classifying the anti-mullerian hormone test 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 the anti-mullerian hormone test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) 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 90 Issue 103 (Friday, May 30, 2025)</title>
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[Federal Register Volume 90, Number 103 (Friday, May 30, 2025)]
[Rules and Regulations]
[Pages 22848-22850]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-09776]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
[Docket No. FDA-2025-N-1281]
Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Classification of the Anti-Mullerian Hormone Test System
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
classifying the anti-mullerian hormone test 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 the anti-mullerian hormone test system's classification. We are
taking this action because we have determined that classifying the
device into class II (special controls) 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 May 30, 2025. The classification was
applicable on December 19, 2016.
FOR FURTHER INFORMATION CONTACT: Ryan Lubert, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3414, Silver Spring, MD 20993-0002, 240-402-6357,
<a href="/cdn-cgi/l/email-protection#87d5fee6e9a9cbf2e5e2f5f3c7e1e3e6a9efeff4a9e0e8f1"><span class="__cf_email__" data-cfemail="1f4d667e7131536a7d7a6d6b5f797b7e3177776c31787069">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the anti-mullerian hormone test
system as class II (special controls), which we have determined will
provide a reasonable assurance of safety and effectiveness. 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 as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 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 (see 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
[[Page 22849]]
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 application 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 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 14, 2015, FDA received Roche Diagnostics' request for
De Novo classification of the Elecsys AMH 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, 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 21 U.S.C. 360c(a)(1)(B)). 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 general
controls, will provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, on December 19, 2016, FDA issued an order to the
requestor classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
862.1092.\1\ We have named the generic type of device anti-mullerian
hormone test system, and it is identified as an in vitro diagnostic
device intended to measure anti-mullerian hormone in human serum and
plasma. An anti-mullerian hormone test system is intended to be used as
an aid for assessing ovarian reserve in women.
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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 following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.
Table 1--Anti-Mullerian Hormone Test System Risks and Mitigation
Measures
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Identified risks to health Mitigation measures
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Inaccurate test results that provide false General controls and special
positive results may lead to a controls (1) (21 CFR
modification, delay or cancellation 862.1092(b)(1)) and (2) (21
before a controlled ovarian stimulation CFR 862.1092(b)(2)).
procedure is initiated.
Inaccurate test results that provide false General controls and special
negative results that may lead to the controls (1) (21 CFR
development of ovarian hyperstimulation 862.1092(b)(1)) and (2) (21
syndrome in patients incorrectly thought CFR 862.1092(b)(2)).
to have normal and/or diminished ovarian
reserve.
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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. 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 order. This device is 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 individually or cumulatively 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. 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 system
[[Page 22850]]
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. 862.1092 to subpart B to read as follows:
Sec. 862.1092 Anti-mullerian hormone test system.
(a) Identification. An anti-mullerian hormone test system is an in
vitro diagnostic device intended to measure anti-mullerian hormone in
human serum and plasma. An anti-mullerian hormone test system is
intended to be used for assessing ovarian reserve in women.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Design verification and validation must include:
(i) An adequate traceability plan to minimize the risk of drift in
anti-mullerian hormone test system results over time.
(ii) Detailed documentation of a prospective clinical study to
demonstrate clinical performance or, if appropriate, results from an
equivalent sample set. This detailed documentation must include the
following information:
(A) Results must demonstrate adequate clinical performance relative
to a well-accepted comparator.
(B) Clinical sample results must demonstrate consistency of device
output throughout the device measuring range that is appropriate for
the intended use population.
(C) Clinical study documentation must include the original study
protocol (including predefined statistical analysis plan), study report
documenting support for the proposed indications for use(s), and
results of all statistical analyses.
(iii) Reference intervals generated by testing an adequate number
of samples from apparently healthy normal individuals in the intended
use population.
(2) The labeling required under Sec. 809.10(b) of this chapter
must include a warning statement that the device is intended to be used
for assessing the ovarian reserve in conjunction with other clinical
and laboratory findings before starting any fertility therapy, and that
the device should be used in conjunction with the antral follicle
count.
Dated: May 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-09776 Filed 5-29-25; 8:45 am]
BILLING CODE 4164-01-P
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