Rule2025-09837
Medical Devices; Radiology Devices; Classification of the Radiological Acquisition and/or Optimization Guidance System
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Published
June 2, 2025
Effective
June 2, 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 radiological acquisition and/or optimization guidance 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 radiological acquisition and/or optimization guidance 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 104 (Monday, June 2, 2025)</title>
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[Federal Register Volume 90, Number 104 (Monday, June 2, 2025)]
[Rules and Regulations]
[Pages 23283-23285]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-09837]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 892
[Docket No. FDA-2025-N-1182]
Medical Devices; Radiology Devices; Classification of the
Radiological Acquisition and/or Optimization Guidance 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 radiological acquisition and/or optimization guidance
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 radiological acquisition and/or
optimization guidance 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 June 2, 2025. The classification was
applicable on February 7, 2020.
FOR FURTHER INFORMATION CONTACT: Shahram Vaezy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3656, Silver Spring, MD 20993-0002, 301-796-6242,
<a href="/cdn-cgi/l/email-protection#d380bbb2bba1b2befd85b2b6a9aa93b5b7b2fdbbbba0fdb4bca5"><span class="__cf_email__" data-cfemail="590a3138312b3834770f383c2320193f3d387731312a773e362f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the radiological acquisition and/
or optimization guidance 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 authorized under section 513(f)(2) of the
[[Page 23284]]
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 August 27, 2019, FDA received Caption Health, Inc.'s request for
De Novo classification of the Caption Guidance. 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 the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, on February 7, 2020, 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
892.2100.\1\ We have named the generic type of device radiological
acquisition and/or optimization guidance system, and it is identified
as a device that is intended to aid in the acquisition and/or
optimization of images and/or diagnostic signals. The device interfaces
with the acquisition system, analyzes its output, and provides guidance
and/or feedback to the operator for improving image and/or signal
quality.
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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--Radiological Acquisition and/or Optimization Guidance System Risks and Mitigation Measures
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Identified risks to health Mitigation measures
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Device Error--Failure to provide guidance on acquiring diagnostic-quality Design verification and
images or signals, leading to delay, prolonged examination, or additional validation, and Labeling.
unnecessary procedures, due to:
<bullet> Algorithm failure.
<bullet> Hardware or software failure.
User Error--Operator failure to follow the guidance provided by the device to Design verification and
acquire diagnostic-quality images or signals, leading to delay, prolonged validation, and Labeling.
examination, or additional unnecessary procedures, due to human error.
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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 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
[[Page 23285]]
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 parts 801 and 809, 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. 892.2100 to subpart B to read as follows:
Sec. 892.2100 Radiological acquisition and/or optimization guidance
system.
(a) Identification. A radiological acquisition and/or optimization
guidance system is a device that is intended to aid in the acquisition
and/or optimization of images and/or diagnostic signals. The device
interfaces with the acquisition system, analyzes its output, and
provides guidance and/or feedback to the operator for improving image
and/or signal quality.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Design verification and validation must include:
(i) A detailed, technical device description, including a detailed
description of the impact of any software and hardware on the device's
functions, the associated capabilities and limitations of each part,
and the associated inputs and outputs.
(ii) A detailed, technical report on the non-clinical performance
testing of the subject device in the intended use environments, using
relevant consensus standards when applicable.
(iii) A detailed report on the clinical performance testing,
obtained from either clinical testing, accepted virtual/physical
systems designed to capture clinical variability, comparison to a
closely-related device with established clinical performance, or other
sources that are justified appropriately. The choice of the method must
be justified given the risk of the device and the general acceptance of
the test methods. The report must include the following:
(A) A thorough description of the testing protocol(s).
(B) A thorough, quantitative evaluation of the diagnostic utility
and quality of images/data acquired, or optimized, using the device.
(C) A thorough, quantitative evaluation of the performance in a
representative user population and patient population, under
anticipated conditions and environments of use.
(D) A thorough discussion on the generalizability of the clinical
performance testing results.
(E) A thorough discussion on use-related risk analysis/human
factors data.
(iv) A detailed protocol that describes, in the event of a future
change, the level of change in the device technical specifications or
indications for use at which the change or changes could significantly
affect the safety or effectiveness of the device and the risks posed by
these changes. The assessment metrics, acceptance criteria, and
analytical methods used for the performance testing of changes that are
within the scope of the protocol must be included.
(v) Documentation of an appropriate training program, including
instructions on how to acquire and process quality images and video
clips, and a report on usability testing demonstrating the
effectiveness of that training program on user performance, including
acquiring and processing quality images.
(2) The labeling required under Sec. 801.109(c) of this chapter
must include:
(i) A detailed description of the device, including information on
all required and/or compatible parts.
(ii) A detailed description of the patient population for which the
device is indicated for use.
(iii) A detailed description of the intended user population, and
the recommended user training.
(iv) Detailed instructions for use, including the information
provided in the training program used to meet the requirements of
paragraph (b)(1)(iv) of this section.
(v) A warning that the images and data acquired using the device
are to be interpreted only by qualified medical professionals.
(vi) A detailed summary of the reports required under paragraphs
(b)(1)(ii) and (iii) of this section.
(vii) A statement on upholding the As Low As Reasonably Achievable
(ALARA) principle with a discussion on the associated device controls/
options.
Dated: May 22, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-09837 Filed 5-30-25; 8:45 am]
BILLING CODE 4164-01-P
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