Rule2025-16033
Medical Devices; Radiology Devices; Classification of the Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox
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Published
August 21, 2025
Effective
August 21, 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 liver iron concentration imaging companion diagnostic for deferasirox 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 liver iron concentration imaging companion diagnostic for deferasirox. 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 90 Issue 160 (Thursday, August 21, 2025)</title>
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[Federal Register Volume 90, Number 160 (Thursday, August 21, 2025)]
[Rules and Regulations]
[Pages 40734-40736]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16033]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 892
[Docket No. FDA-2025-N-2369]
Medical Devices; Radiology Devices; Classification of the Liver
Iron Concentration Imaging Companion Diagnostic for Deferasirox
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 liver iron concentration imaging companion diagnostic
for deferasirox 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 liver iron
concentration imaging companion diagnostic for deferasirox. 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 August 21, 2025. The classification was
applicable on January 23, 2013.
FOR FURTHER INFORMATION CONTACT: Daniel Krainak, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3674, Silver Spring, MD 20993-0002, 301-796-0478,
<a href="/cdn-cgi/l/email-protection#81c5e0efe8e4edafcaf3e0e8efe0eac1e7e5e0afe9e9f2afe6eef7"><span class="__cf_email__" data-cfemail="c98da8a7a0aca5e782bba8a0a7a8a289afada8e7a1a1bae7aea6bf">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the liver iron concentration
imaging companion diagnostic for deferasirox 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 (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 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
[[Page 40735]]
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 21, 2012, FDA received Resonance Health Services'
request for De Novo classification of the FerriScan R2-MRI Analysis
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 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 January 23, 2013, 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
892.1001.\1\ We have named the generic type of device ``liver iron
concentration imaging companion diagnostic for deferasirox'', and it is
identified as an image processing device intended to aid in the
identification and monitoring of non-transfusion-dependent thalassemia
patients receiving therapy with deferasirox. The device calculates a
numeric value for liver iron concentration based on magnetic resonance
images acquired under controlled conditions. The calculated numeric
value is used to assess the need for deferasirox treatment and for
monitoring treatment in patients with non-transfusion-dependent
thalassemia. The liver iron concentration imaging companion diagnostic
for deferasirox is essential to the safe and effective use of
deferasirox in patients with non-transfusion-dependent thalassemia.
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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--Liver Iron Concentration Imaging Companion Diagnostic for
Deferasirox Risks and Mitigation Measures
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Identified risks to health Mitigation measures
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False positive result.................. Special controls (1), (2)(i),
and (2)(ii).
False negative result.................. Special controls (1), (2)(i),
and (2)(ii).
Sensitivity and specificity are not Special controls (1) and
suitable for clinical decision making. (2)(iii).
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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 final 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 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 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 892
Medical devices, Radiation protection, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
892 is amended as follows:
PART 892--RADIOLOGY DEVICES
0
1. The authority citation for part 892 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 892.1001 to subpart B to read as follows:
[[Page 40736]]
Sec. 892.1001 Liver iron concentration imaging companion diagnostic
for deferasirox.
(a) Identification. The liver iron concentration imaging companion
diagnostic for deferasirox is an image processing device intended to
aid in the identification and monitoring of non-transfusion-dependent
thalassemia patients receiving therapy with deferasirox. The device
calculates a numeric value for liver iron concentration based on
magnetic resonance images acquired under controlled conditions. The
calculated numeric value is used to assess the need for deferasirox
treatment and for monitoring treatment in patients with non-
transfusion-dependent thalassemia. The liver iron concentration imaging
companion diagnostic for deferasirox is essential to the safe and
effective use of deferasirox in patients with non-transfusion-dependent
thalassemia.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Design verification and validation must include nonclinical and
clinical performance testing demonstrating the bias, precision,
repeatability, and reproducibility of liver iron concentration
measurements.
(2) Labeling must include specifying:
(i) Instructions for acceptance testing of images prior to
processing;
(ii) Data processing quality assurance protocols; and
(iii) The sensitivity and specificity of liver iron concentration
measurements.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16033 Filed 8-20-25; 8:45 am]
BILLING CODE 4164-01-P
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