[Federal Register Volume 90, Number 121 (Thursday, June 26, 2025)]
[Rules and Regulations]
[Pages 27236-27238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-11791]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 892
[Docket No. FDA-2025-N-1361]
Medical Devices; Radiology Devices; Classification of the Cream
for X-Ray Attenuation
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
classifying the cream for x-ray attenuation 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 cream for x-ray attenuation'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 26, 2025. The classification was
applicable on May 9, 2013.
FOR FURTHER INFORMATION CONTACT: Scott McFarland, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3572, Silver Spring, MD 20993-0002, 301-
796-6217, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the cream for x-ray attenuation 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
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 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 February 4, 2013, FDA received BloXR Corporation's request for
De Novo classification of the X-ray Attenuating Cream. 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.
[[Page 27237]]
Therefore, on May 9, 2013, 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
892.6510.\1\ We have named the generic type of device cream for x-ray
attenuation, and it is a sterile cream intended for use as a radiation
shield. It is intended to be applied to the user's hand before donning
gloves, or it may be applied on a glove on the hand, followed by
donning a second glove. Cream for x-ray attenuation is intended to be
used during medical procedures in which hands are necessarily exposed
to radiation to offer some degree of protection from radiation exposure
in the diagnostic imaging range of up to 130 kVp. This may include
surgical procedures that require the use of fluoroscopy or radiography
or other procedures. Cream for x-ray attenuation is not intended to be
used in or adjacent to the primary x-ray beam or the transmitted beam
and should not be used in lieu of a Radiographic Procedure Glove, which
is used in radiography for those studies requiring the physician's hand
or forearm be in the direct path of the primary x-ray beam.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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--Cream for X-Ray Attenuation Risks and Mitigation Measures
------------------------------------------------------------------------
Identified risks to health Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction to health care (1) Biocompatibility testing,
professionals and patients as a result (2) Surgical glove
of direct contact to the skin. compatibility performance
testing, and
(3) Identification of
compatible surgical gloves in
labeling.
Infection risk to patient as a result (1) Sterilization, packaging,
of patient contact with contaminated and expiration date testing,
cream due to glove failure and the (2) Sterile device and
cream flaking off onto the patient. expiration date statement in
labeling,
(3) Surgical glove
compatibility performance
testing, and
(4) Identification of
compatible surgical gloves in
labeling.
Radiation exposure to health care (1) Boxed warning in labeling,
professionals due to lack of radiation (2) Attenuation information in
attenuation because of cream labeling,
formulation. The radiation attenuating (3) Surgical glove
agent in the cream may not be present compatibility performance
in high enough concentration or is not testing,
appropriate to provide the amount of (4) Attenuation performance
protection needed. testing, and
(5) Application performance
testing.
Radiation exposure to health care (1) Boxed warning in labeling,
professional during actual use (lack (2) Attenuation information in
of effectiveness). Lack of continuous labeling,
protection during actual use can (3) Surgical glove
result from poor cream composition compatibility performance
such that the cream will absorb, testing,
crack, flake off, etc. during use in a (4) Attenuation performance
clinical setting. testing,
(5) Application performance
testing, and
(6) Validated device
application instructions for
effective shielding in
labeling.
Radiation exposure to health care (1) Validated device
professionals due to inconsistent application instructions for
device application. Radiation exposure effective shielding in
can result due to inadequate labeling.
instructions describing how to apply
the cream to ensure that the hands are
completely covered and covered with
enough cream to provide the amount of
radiation protection stated in the
labeling.
------------------------------------------------------------------------
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. 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. 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, and 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:
[[Page 27238]]
PART 892--RADIOLOGY DEVICES
0
1. The authority citation for 21 CFR part 892 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 892.6510 to subpart G to read as follows:
Sec. 892.6510 Cream for x-ray attenuation.
(a) Identification. A cream for x-ray attenuation is a sterile
cream intended for use as a radiation shield. It is intended to be
applied to the user's hand before donning gloves, or it may be applied
on a glove on the hand, followed by donning a second glove. Cream for
x-ray attenuation is intended to be used during medical procedures in
which hands are necessarily exposed to radiation to offer some degree
of protection from radiation exposure in the diagnostic imaging range
of up to 130 kVp. This may include surgical procedures that require the
use of fluoroscopy or radiography or other procedures. Cream for x-ray
attenuation is not intended to be used in or adjacent to the primary x-
ray beam or the transmitted beam and should not be used in lieu of a
Radiographic Procedure Glove, which is used in radiography for those
studies requiring the physician's hand or forearm be in the direct path
of the primary x-ray beam.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Design verification and validation must include documentation
of results from safety and effectiveness testing. The results from
safety and effectiveness testing must include:
(i) Biocompatibility data consistent with the intended use for the
device;
(ii) Sterilization, packaging, and expiration date testing; and
(iii) Nonclinical and/or clinical performance testing
representative of ``as use'' conditions demonstrating:
(A) Compatibility to the type(s) of surgical glove (e.g., latex,
nitrile, vinyl) to be used with the device;
(B) Attenuation performance; and
(C) Proper application of the device.
(2) Labeling must include:
(i) A statement that the device is sterile and an expiration date.
(ii) A boxed warning statement prominently placed in all labeling
material for these devices. That boxed warning statement must read:
``The device is not intended to be used in or adjacent to the primary
X-ray beam or transmitted beam and should not be used in lieu of a
Radiographic Procedure Glove, which is used in radiography for those
studies requiring the physician's hand or forearm be in the direct path
of the primary X-ray beam.''
(iii) The methods and results from nonclinical and/or clinical
performance testing representative of ``as use'' conditions
demonstrating the amount of attenuation the device provides to the end
user at 60, 80, 100, and 120 kVp.
(iv) Validated instructions for use for device application and a
statement of how often the device must be removed and reapplied for
effective shielding.
(v) Identification of the type(s) of surgical glove (e.g., latex,
nitrile, vinyl) that is compatible for use with the device.
Dated: June 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11791 Filed 6-25-25; 8:45 am]
BILLING CODE 4164-01-P