Rule2026-08424
Medical Devices; Radiology Devices; Classification of the Radiation Therapy Marking Device
Primary source
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Published
April 30, 2026
Effective
April 30, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the radiation therapy marking device 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 radiation therapy marking device. 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 83 (Thursday, April 30, 2026)</title>
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[Federal Register Volume 91, Number 83 (Thursday, April 30, 2026)]
[Rules and Regulations]
[Pages 23166-23168]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-08424]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 892
[Docket No. FDA-2026-N-4270]
Medical Devices; Radiology Devices; Classification of the
Radiation Therapy Marking Device
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
radiation therapy marking device 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 radiation therapy marking device. 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 April 30, 2026. The classification was
applicable on December 10, 2021.
FOR FURTHER INFORMATION CONTACT: Lynne Fairobent, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3663, Silver Spring, MD 20993-0002, 301-
796-4817, <a href="/cdn-cgi/l/email-protection#9cd0e5f2f2f9b2dafdf5eef3fef9f2e8dcfaf8fdb2f4f4efb2fbf3ea"><span class="__cf_email__" data-cfemail="8ac6f3e4e4efa4ccebe3f8e5e8efe4fecaeceeeba4e2e2f9a4ede5fc">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the radiation
therapy marking device 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 22, 2020, FDA received Medical Precision B.V.'s request for
De Novo classification of the Comfort Marker 2.0. 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 December 10, 2021, 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
892.5785.\1\ We have named the
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generic type of device ``radiation therapy marking device,'' and it is
identified as a powered device that transdermally delivers a permanent
or temporary colorant to the skin for the purpose of placing marks to
guide radiation therapy. This classification does not include devices
with reusable or reprocessed needles or devices intended for
diagnostic, therapeutic, or aesthetic use or to deliver other products
for these uses.
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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.
Table 1--Risks to Health and Mitigation Measures for the Radiation
Therapy Marking Device
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Identified risks to health Mitigation measures
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Adverse tissue reaction.............. Biocompatibility evaluation.
Cross contamination and infection.... Reprocessing validation;
Sterilization validation; Non-
clinical performance testing;
Shelf-life testing; and
Labeling.
Needle stick injury to provider...... Non-clinical performance testing;
and Labeling.
Device and/or software failure Clinical performance testing; Non-
leading to ineffective marking. clinical performance testing;
Software validation,
verification, and hazard
analysis; and Labeling.
Electrical shock or electromagnetic Electromagnetic compatibility
interference with other devices. testing; Electrical safety
testing; and Labeling.
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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.
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 radiation therapy marking
devices. 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 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. 892.5785 to subpart F to read as follows:
Sec. 892.5785 Radiation therapy marking device.
(a) Identification. A radiation therapy marking device is a powered
device that transdermally delivers a permanent or temporary colorant to
the skin for the purpose of placing marks to guide radiation therapy.
This classification does not include devices with reusable or
reprocessed needles or devices intended for diagnostic, therapeutic, or
aesthetic use or to deliver other products for these uses.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Design verification and validation must include:
(i) Documentation of performance data from studies that
demonstrate:
(A) The indicated colorant is compatible with the device and its
method of delivery;
(B) The device can reproducibly deliver the indicated colorant with
the specifications described; and
(C) The length of time that compatible colorants remain visible on
the skin following device application.
(ii) Documentation of performance data from studies that
demonstrate:
(A) Accuracy and reproducibility of needle penetration depth;
(B) Device protection from cross-contamination, including fluid
ingress protection;
(C) Adequacy of the cleaning and disinfection instructions to
ensure that the reusable components of the device can be cleaned and
disinfected; and
(D) The sterility of all patient-contacting components (e.g.,
safety needle).
(iii) Documentation of performance data from studies that
demonstrate electrical safety and electromagnetic compatibility of all
electrical components of the device.
(iv) Documentation of performance data from studies that
demonstrate continued sterility, package integrity,
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and device functionality over the intended shelf life.
(v) Documentation of software verification, validation, and hazard
analysis.
(2) The labeling required under Sec. 801.109(c) of this chapter
must include:
(i) An explanation of the device and the mechanism of operation;
(ii) Validated methods and instructions for reprocessing of any
reusable components;
(iii) Disposal instructions; and
(iv) A shelf life for all sterile components.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-08424 Filed 4-29-26; 8:45 am]
BILLING CODE 4164-01-P
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