Proposed Rule2026-16209
Radiology Devices; Reclassification of Digital Breast Tomosynthesis System
Primary source
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Published
August 10, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is proposing to reclassify digital breast tomosynthesis (DBT) systems, product code OTE, which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "Digital Breast Tomosynthesis System," to identify these devices along with special controls that FDA believes are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.
Full Text
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<title>Federal Register, Volume 91 Issue 152 (Monday, August 10, 2026)</title>
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[Federal Register Volume 91, Number 152 (Monday, August 10, 2026)]
[Proposed Rules]
[Pages 51406-51416]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-16209]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 892
[Docket No. FDA-2026-N-7630]
Radiology Devices; Reclassification of Digital Breast
Tomosynthesis System
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed amendment; proposed order; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify digital breast tomosynthesis (DBT) systems, product code
OTE, which are postamendments class III devices, from class III
(premarket approval) into class II (special controls), subject to
premarket notification. FDA is also proposing a new device
classification regulation with the name ``Digital Breast Tomosynthesis
System,'' to identify these devices along with special controls that
FDA believes are necessary to provide a reasonable assurance of the
safety and effectiveness of these devices.
DATES: Either electronic or written comments on the proposed order must
be submitted by October 9, 2026. Please see section X of this document
for the proposed effective date when the new requirements apply and for
the proposed effective date of a final order based on this proposed
order.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 9, 2026. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or
[[Page 51407]]
anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2026-N-7630 for ``Radiology Devices; Reclassification of Digital
Breast Tomosynthesis System.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents, the
plain language summary of the proposed order of not more than 100 words
consistent with the ``Providing Accountability Through Transparency
Act,'' or the electronic and written/paper comments received, go to
<a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in
brackets in the heading of this document, into the ``Search'' box and
follow the prompts and/or go to the Dockets Management Staff, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Yanna Kang, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3544, Silver Spring, MD 20993-0002, 301-796-6704,
<a href="/cdn-cgi/l/email-protection#fba29a95959ad5b09a959cbb9d9f9ad5939388d59c948d"><span class="__cf_email__" data-cfemail="a0f9c1cecec18eebc1cec7e0c6c4c18ec8c8d38ec7cfd6">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background--Regulatory Authorities
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as
amended, establishes a comprehensive system for the regulation of
medical devices intended for human use. Section 513 of the FD&C Act (21
U.S.C. 360c) establishes three classes of devices, reflecting the
regulatory controls needed to provide reasonable assurance of their
safety and effectiveness. The three classes of devices are class I
(general controls), class II (special controls), and class III
(premarket approval).
Section 513(a)(1) of the FD&C Act defines the three classes of
devices. Class I devices are those devices for which the general
controls of the FD&C Act (controls authorized by or under section 501,
502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h,
360i, or 360j) or any combination of such sections) are sufficient to
provide reasonable assurance of the safety and effectiveness of the
device; or those devices for which insufficient information exists to
determine that general controls are sufficient to provide reasonable
assurance of safety and effectiveness or to establish special controls
to provide such assurance, but because the devices are not purported or
represented to be for a use in supporting or sustaining human life or
for a use which is of substantial importance in preventing impairment
of human health, and do not present a potential unreasonable risk of
illness or injury, are to be regulated by general controls (section
513(a)(1)(A) of the FD&C Act).
Class II devices are those devices for which general controls by
themselves are insufficient to provide reasonable assurance of safety
and effectiveness, and for which there is sufficient information to
establish special controls to provide such assurance, including the
issuance of performance standards, postmarket surveillance, patient
registries, development and dissemination of guidelines,
recommendations, and other appropriate actions FDA (the Agency or we)
deems necessary to provide such assurance (section 513(a)(1)(B) of the
FD&C Act).
Class III devices are those devices for which insufficient
information exists to determine that general controls and special
controls would provide a reasonable assurance of safety and
effectiveness, and are purported or represented to be for a use in
supporting or sustaining human life or for a use which is of
substantial importance in preventing impairment of human health, or
present a potential unreasonable risk of illness or injury (section
513(a)(1)(C) of the FD&C Act).
Devices that were not introduced or delivered for introduction into
interstate commerce for commercial distribution before May 28, 1976,
(generally referred to as ``postamendments devices'') are automatically
classified by section 513(f)(1) of the FD&C Act into class III without
any FDA rulemaking process. Those devices remain in class III and
require approval of a premarket approval application (PMA) unless, and
until: (1) FDA reclassifies the device into class I or II, or (2) FDA
issues an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807, subpart E, of the regulations (21 CFR
part 807, subpart E).
A postamendments device that has been initially classified in class
III under section 513(f)(1) of the FD&C Act may be reclassified into
class I or II under section 513(f)(3) of the FD&C Act. Section
513(f)(3) of the FD&C Act provides that FDA, acting by
[[Page 51408]]
administrative order, can reclassify the device into class I or II on
its own initiative, or in response to a petition from the manufacturer
or importer of the device. To change the classification of the device,
the proposed new class must have sufficient regulatory controls to
provide a reasonable assurance of the safety and effectiveness of the
device for its intended use.\1\
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\1\ See generally section 513 of the FD&C Act.
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FDA relies upon ``valid scientific evidence,'' as stated in section
513(a)(3) of the FD&C Act and defined in 21 CFR 860.7(c)(2), in the
classification process to determine the level of regulation for
devices.\2\ In general, to be considered in the reclassification
process, the ``valid scientific evidence'' upon which the Agency relies
must be publicly available. Publicly available information excludes
trade secret and/or confidential commercial information, e.g., the
contents of a pending PMA (see section 520(c) of the FD&C Act). Section
520(h)(4) of the FD&C Act provides that FDA may use, for
reclassification of a device, certain information in a PMA 6 years
after the application has been approved. This includes information from
clinical and preclinical tests or studies that demonstrate the safety
and effectiveness of the device, but it does not include descriptions
of methods of manufacture and product composition and other trade
secrets.
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\2\ See generally id.
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In accordance with section 513(f)(3) of the FD&C Act, FDA is
issuing this proposed order to reclassify DBT systems intended to
generate digital cross-sectional x-ray images of the breast that can be
used for the screening and diagnosis of breast cancer for prescription
use only (product code OTE),\3\ which are postamendments class III
devices, into class II (special controls), subject to premarket
notification, because FDA believes the standard in section 513(a)(1)(B)
of the FD&C Act is met as general controls by themselves are
insufficient to provide reasonable assurance of the safety and
effectiveness of these devices, and there is sufficient information to
establish special controls, which, in addition to general controls,
will provide reasonable assurance of the safety and effectiveness of
these devices.\4\
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\3\ FDA's Center for Devices and Radiological Health (CDRH) uses
product codes to assist in accurate identification and tracking of
current medical devices and to allow for tracking of and easy
reference to predicate device types. A product code consists of a
three-letter combination which associates a device's type with a
product classification designated for the application. The three-
digit classification product codes in CDRH's Product Classification
Database carry no other significance. See FDA's guidance titled
``Medical Device Classification Product Codes'', available at
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-classification-product-codes-guidance-industry-and-food-and-drug-administration-staff">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-classification-product-codes-guidance-industry-and-food-and-drug-administration-staff</a>.
\4\ FDA notes that the ACTION caption for this proposed order is
styled as ``Proposed amendment; proposed order; request for
comments'' rather than ``Proposed 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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Based on the PMA data available to FDA in accordance with section
520(h)(4) of the FD&C Act,<SUP>5 6</SUP> associated Panel
deliberations, published peer-reviewed literature, and data available
to the Agency demonstrating a lack of significant postmarket safety
signals, FDA believes there is sufficient information to reclassify
these devices from class III (premarket approval) into class II
(special controls). Therefore, FDA is proposing to establish a new
device classification regulation, ``Digital Breast Tomosynthesis
System'' and classify this device type into class II along with the
special controls that the Agency believes are necessary to provide a
reasonable assurance of the safety and effectiveness of these devices.
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\5\ In proposing to reclassify DBT systems from class III to
class II, FDA, on its own initiative, is relying on data from
relevant PMAs and a relevant PMA panel-track supplement, available
to FDA with product code OTE, in accordance with the six-year rule.
See section 520(h)(4) of the FD&C Act; see also, FDA guidance titled
``Guidance on Section 216 of the Food and Drug Administration
Modernization Act of 1997--Guidance for Industry and for FDA
Reviewers,'' available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-section-216-food-and-drug-administration-modernization-act-1997-guidance-industry-and-fda">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-section-216-food-and-drug-administration-modernization-act-1997-guidance-industry-and-fda</a>. The data for this specific proposed reclassification was
from relevant PMAs and a PMA panel-track supplement approved after
November 28, 1990, and before January 11, 2020, as noted in section
II of this proposed order. See also, FDA's premarket approval
database, available at <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm</a>.
\6\ For the purpose of this proposed order, PMA data considered
in accordance with section 520(h)(4) includes only that data which
was submitted to and therefore considered by FDA at the time the PMA
was reviewed and approval was issued.
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Under the FD&C Act, premarket notification (510(k)) submissions are
required to reasonably assure the safety and effectiveness of class II
devices unless FDA determines that the device type should be exempt
from 510(k) requirements under section 510(m) of the FD&C Act.\7\ FDA
has not made this determination for DBT systems, and therefore, FDA is
not proposing that this class II device type be exempt from the 510(k)
requirements. If this proposed order is finalized, persons who intend
to market a DBT system must submit to FDA a premarket notification
under section 510(k) of the FD&C Act and receive clearance prior to
marketing the device.
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\7\ In considering whether to exempt class II devices from
premarket notification, FDA considers whether premarket notification
for the type of device is necessary to provide reasonable assurance
of safety and effectiveness of the device. FDA generally considers
the factors initially identified in the January 21, 1998, Federal
Register notice (63 FR 3142) and further explained in FDA's guidance
issued on February 19, 1998, titled ``Procedures for Class II Device
Exemptions from Premarket Notification, Guidance for Industry and
CDRH Staff'' in determining whether premarket notification is
necessary for class II devices. FDA also considers that, even when
exempting devices from the 510(k) requirements, these devices would
still be subject to certain limitations on exemptions, for example,
the general limitations set forth in 21 CFR 892.9.
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II. Regulatory History of the Device
In accordance with section 513(f)(1) of the FD&C Act, DBT systems
are automatically classified into class III because they were not
introduced or delivered for introduction into interstate commerce for
commercial distribution before May 28, 1976, have not been reclassified
into class I or II, and have not been found substantially equivalent to
a device placed in commercial distribution after May 28, 1976, which
was subsequently classified or reclassified into class II or class I.
Therefore, these devices are subject to the PMA requirements under
section 515 of the FD&C Act (21 U.S.C. 360e).
The proposed reclassification applies to DBT systems that are
prescription use devices (product code OTE) intended to generate
digital cross-sectional x-ray images of the breast that can be used for
the screening and diagnosis of breast cancer. As discussed further
below, FDA approved the first DBT system on February 11, 2011(Refs. 1
and 2). Since the first approval order for a DBT system, FDA has
reviewed and approved 3 additional original PMAs (P130020 (Ref. 3),
P140011 (Ref. 4), P160031 (Ref. 5)) and 26 PMA supplements, including 1
panel-track supplement (P080003/S001 (Ref. 6)), under product code OTE.
In accordance with the ``six-year rule'' described in section 520(h)(4)
of the FD&C Act (21 U.S.C. 360j(h)(4)), FDA considered data contained
in each of the original PMAs as well as the panel-track supplement \8\
as part of the evidence being relied
[[Page 51409]]
upon \9\ to support the proposed reclassification from class III to II.
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\8\ The term ``panel-track supplement'' is defined in section
737(4)(B) of the FD&C Act, as, ``a supplement to an approved
premarket application or premarket report under section 515 that
requests a significant change in design or performance of the
device, or a new indication for use of the device, and for which
substantial clinical data are necessary to provide a reasonable
assurance of safety and effectiveness.''
\9\ In accordance with section 520(h)(4) of the FD&C Act, FDA
has not relied on information in PMA supplements approved within the
last 6 years to develop the proposed special controls or to
otherwise inform this proposed reclassification action.
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While the DBT systems that are the subject of the four original
PMAs have unique attributes in certain respects (e.g., angular span),
FDA has determined that these DBT systems have sufficiently similar
purposes, design considerations, functions, and other features related
to safety and effectiveness such that the information and data reviewed
and analysis conducted by FDA was analogous across all applications
available to the Agency. As such, and to avoid redundancy, the
summaries below are intended to provide examples that are
representative of the PMA information and data that was reviewed and
considered by FDA across the applications in proposing to reclassify
DBT systems from class III (premarket approval) into class II (special
controls).
On January 22, 2008, FDA filed an original PMA (P080003 (Ref. 1))
for the Selenia Dimensions 3D system from Hologic, Inc. The
Radiological Devices Panel (the ``Panel'') met on September 24, 2010,
and deliberated on the Selenia Dimensions 3D system PMA (Ref. 2) and
the Panel's consensus was that the benefits of the device outweighed
the risks for the proposed indications. On February 11, 2011, FDA
approved the original PMA for the Selenia Dimensions 3D system, the
first DBT system to obtain premarket approval (Ref. 1). The Selenia
Dimensions 3D system is intended for use in the same clinical
applications as full field digital mammography (FFDM). The system can
be used to generate both a two-dimensional (2D) FFDM image set and a
three-dimensional (3D) DBT image set and the screening examination is
intended to consist of a 2D FFDM image set plus a 3D DBT image set.
On October 22, 2012, FDA filed a panel-track supplement to the
original PMA (P080003/S001 (Ref. 6)) seeking to expand the indications
for use for the Selenia Dimensions 3D system with C-View Software
Module to include the capability to generate synthesized 2D views as an
alternative to 2D FFDM views to be reviewed along with DBT images,
thereby reducing the cumulative radiation exposure for a screening
exam. The Panel met again on October 24, 2012 (Ref. 7), to review the
panel-track PMA supplement, and the consensus of the Panel (with no
Panel members abstaining) was that the benefits outweigh the risks of
the Selenia Dimensions 3D System with C-View Software Module (synthetic
2D or s2D) for the proposed indications for use. The single dissent
from one Panel member was due to concerns with the generalizability of
the clinical study results in support of the proposed indication for
use given the study design and specific study exclusions (patients with
large breasts, implants, or tissue markers). As further elaborated in
section VI, which discusses the use and adoption of this technology
since these approvals, FDA believes that the concerns expressed by the
dissenting Panel member have been addressed as a result of the
significant amount of subsequently generated data demonstrating the
safety and effectiveness of DBT systems with the capability to generate
synthetic 2D images.
Based on a search of FDA's Medical Device Recalls database using
product code OTE, as of July 21, 2026 FDA has received no Class III
recalls, five Class II recalls, and no Class I recalls \10\ for DBT
systems. Of the Class II recalls, one was due to potential errors in
image reconstruction in cases where breasts with a thickness greater
than 90 mm covered nearly the entire detector surface, one was due to
the potential that unexpected movement by the c-arm might cause blunt
trauma should the tube arm impinge upon an individual, one was due to a
software issue that may impact image quality when the device is used in
certain modalities, one was due to an unapproved slabbing software
function enabled for use, and one was due to systems developing loose,
missing, or broken internal bolts over time. No injuries have been
reported as a result of these recalls. Based on a search of FDA's
Manufacturer and User Facility Device Experience (MAUDE) database using
product code OTE, as of July 21, 2026 FDA has received 968 Medical
Device Reports (MDRs). While this represents a notable volume of
reports, the majority of the MDRs reported indicated no known impact or
consequence to patient, no patient involvement, and/or no clinical
signs, symptoms, or conditions. Moreover, the majority of MDRs
documented straightforward resolutions to identified problems, such as
replacing a part or tightening loose hardware. About 1 percent of these
MDRs reported serious injury attributed to the use of the device, but
not necessarily caused by the device (e.g., a technologist operating
the device slipped and twisted an ankle). FDA's analysis of these MDRs,
in conjunction with the identified risks to health, demonstrates that
the reported adverse events align with known risk categories and can be
effectively addressed with special controls to provide a reasonable
assurance of the safety and effectiveness of DBT systems.
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\10\ Class I, II, and III recalls are defined in 21 CFR 7.3(m).
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III. Device Description
DBT systems are postamendments devices classified into class III
under section 513(f)(1) of the FD&C Act. DBT systems are prescription
devices that are intended to generate digital cross-sectional x-ray
images of the breast that can be used for the screening and diagnosis
of breast cancer. DBT systems may include various components, such as
acquisition hardware, x-ray tube, x-ray generator, breast compression
system and software, digital image receptor, acquisition workstation,
automatic exposure control, image processing and reconstruction
programs, patient and equipment support devices, and other components.
The device acquires 2D projection images by moving the tube head in a
specific limited angular arc over the stationary compressed breast
capturing multiple images at multiple angles during a short scan. These
individual images are then reconstructed into a series of thin slices
that can be displayed on a workstation. DBT systems enable generating
2D and 3D images, separately or combined under a single compression.
Additionally, 2D images or slabs may be synthesized from the 3D images
for viewing along with the original images.
In addition, DBT is considered a mammographic modality under the
Mammography Quality Standards Act (MQSA) (Pub. L. 102-539), and
facilities that perform mammography using DBT systems are subject to
MQSA requirements.\11\ The MQSA regulations define a mammographic
modality as ``a
[[Page 51410]]
technology [. . .] for radiography of the breast.'' \12\
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\11\ See Mammography Quality Standards Act of 1992, Public Law
102-539, codified at 42 U.S.C. 263b (MQSA), enacted on October 27,
1992; see also 21 CFR 900.2(z). Congress enacted MQSA to ensure that
all people have access to quality mammography for the detection of
breast cancer in its earliest, most treatable stages. Following
enactment of the law, FDA developed and implemented MQSA
regulations, the most recent version of which went into effect on
September 10, 2024, available at <a href="https://www.federalregister.gov/documents/2023/03/10/2023-04550/mammography-quality-standards-act">https://www.federalregister.gov/documents/2023/03/10/2023-04550/mammography-quality-standards-act</a>.
FDA also issued the Mammography Quality Standards Act and Regulation
Amendments: Small Entity Compliance Guide on August 26, 2024,
available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/mammography-quality-standards-act-and-regulation-amendments-small-entity-compliance-guide">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/mammography-quality-standards-act-and-regulation-amendments-small-entity-compliance-guide</a>.
\12\ 21 CFR 900.2(z).
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IV. Proposed Reclassification and Summary of Reasons for
Reclassification
In accordance with section 513(f)(3) of the FD&C Act and 21 CFR
part 860, subpart C, FDA is proposing to reclassify DBT systems, which
are postamendments devices, from class III into class II, subject to
premarket notification (510(k)) requirements under section 510(k) of
the FD&C Act. FDA believes that there is sufficient data and
information available to the Agency through the data and information
provided in original PMAs and one panel-track supplement that may be
considered under section 520(h)(4) of the FD&C Act (Refs. 1 and 3 to
6), associated Panel deliberations (Refs. 2 and 7), published peer-
reviewed literature (Refs. 8 to 10), FDA's MAUDE database, and the
Medical Device Recalls database to establish special controls. More
specifically, in evaluating these data sources, FDA has identified the
risks to health for inclusion in the overall risk assessment of DBT
systems and is proposing special controls that include mitigation
measures for each of the risks to health identified in section V. FDA
believes that these special controls, together with general controls,
would effectively mitigate the risks to health identified in section V
and are necessary to provide a reasonable assurance of safety and
effectiveness of these devices. The Agency does not believe that the
general controls applicable to the devices are sufficient to
effectively mitigate the risks to health identified for these devices,
and therefore, does not believe that the general controls applicable to
the devices are sufficient to provide reasonable assurance of the
safety and effectiveness of these devices.
FDA is proposing to revise 21 CFR part 892 to create a new device
classification regulation with the name ``Digital Breast Tomosynthesis
System.'' DBT systems are intended for the generation of digital cross-
sectional x-ray images of the breast that can be used for the screening
and diagnosis of breast cancer. Under this proposed order, if
finalized, DBT systems will be identified as intended for prescription
use. Prescription use devices are exempt from the requirement for
adequate directions for use for the layperson under section 502(f)(1)
of the FD&C Act (21 U.S.C. 352(f)(1)) and Sec. 801.5 (21 CFR 801.5),
if the conditions of Sec. 801.109 are met.
Under the FD&C Act, 510(k) submissions are required to reasonably
assure the safety and effectiveness of class II devices unless FDA
determines that the device type should be exempt from 510(k)
requirements under section 510(m) of the FD&C Act.\13\ FDA has not made
this determination for DBT systems, and therefore, FDA is not proposing
this class II device type be exempt from 510(k) requirements. If this
proposed order is finalized, persons who intend to market a DBT system
will need to submit to FDA a 510(k) and receive clearance prior to
marketing the device.
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\13\ See supra note 7.
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This proposed order does not apply to FFDM systems, which FDA has
previously classified under 21 CFR 892.1715. FFDM systems are in class
II (special controls) \14\ under their respective classification
regulation, in addition to general controls. Further, this proposed
order does not apply to other cross-sectional mammographic x-ray
systems, such as Dedicated Breast Computed Tomography System,\15\ which
remains a class III device.
---------------------------------------------------------------------------
\14\ The special controls for FFDM systems can be found in FDA's
special control guidance titled ``Full-Field Digital Mammography
System--Class II Special Controls'' (FFDM Guidance), available at
<a href="https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/full-field-digital-mammography-system-class-ii-special-controls-guidance-industry-and-fda-staff">https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/full-field-digital-mammography-system-class-ii-special-controls-guidance-industry-and-fda-staff</a>.
\15\ A dedicated breast computed tomography system is a cross-
sectional mammographic x-ray system that is generally regarded as a
different modality than DBT by clinicians. Unlike a DBT system,
which is intended for screening and diagnosis of breast cancer, this
device is intended for diagnostic purposes only under product code
OLQ.
---------------------------------------------------------------------------
This proposed order, if finalized, will decrease regulatory burden
on industry, as manufacturers will no longer have to submit a PMA for
these types of devices but can instead submit a 510(k) to the Agency
for review prior to marketing their device. The 510(k) pathway is less
burdensome and generally more cost-effective for industry and FDA than
the PMA pathway, the most stringent type of device marketing
application required by FDA. A 510(k) typically results in a shorter
premarket review timeline compared to a PMA, which ultimately may
provide more timely patient access for these types of devices. FDA
expects that the reclassification of these devices would enable more
manufacturers to develop these types of devices such that patients
would benefit from increased access to appropriately safe and effective
devices.
Additionally, manufacturers may wish to use predetermined change
control plans (PCCPs) to implement future modifications to their
devices without needing to submit a new 510(k) for each significant
change or modification \16\ while continuing to provide a reasonable
assurance of device safety and effectiveness.\17\ FDA reviews a PCCP as
part of a marketing submission for a device to ensure the continued
safety and effectiveness of the device without necessitating additional
marketing submissions for implementing each modification described in
the PCCP. When used appropriately, PCCPs authorized by FDA are expected
to be least burdensome for manufacturers and FDA.\18\
---------------------------------------------------------------------------
\16\ For the purpose of this proposed order reference to
``modification'' means a significant change or modification that
would generally require a new premarket notification under 21 CFR
807.81(a)(3). For additional details, see FDA guidances titled
``Deciding When to Submit a 510(k) for a Change to an Existing
Device,'' available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device</a> and ``Deciding When to Submit a 510(k) for a
Software Change to an Existing Device,'' available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-software-change-existing-device">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-software-change-existing-device</a>.
\17\ Section 3308 of the Food and Drug Omnibus Reform Act of
2022, Title III of Division FF of the Consolidated Appropriations
Act, 2023, Public Law 117-328 (FDORA), enacted on December 29, 2022,
added section 515C ``Predetermined Change Control Plans for
Devices'' to the FD&C Act. Section 515C has provisions regarding
predetermined change control plans (PCCPs) for devices requiring
premarket approval or premarket notification. Under section 515C,
supplemental applications (section 515C(a)) and new premarket
notifications (section 515C(b)) are not required for a change to a
device that would otherwise require a premarket approval supplement
or new premarket notification if the change is consistent with a
PCCP approved or cleared by FDA.
\18\ Sections 513 and 515 of the FD&C Act. See also, FDA's
guidance titled ``The Least Burdensome Provisions: Concept and
Principles,'' available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles</a>.
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V. Risks to Health
After consideration of FDA's accumulated experience with these
devices from review of the data and information provided in each DBT
system original PMA and a panel-track supplement that may be considered
under section 520(h)(4) of the FD&C Act (Refs. 1 and 3 to 6),
associated Panel deliberations (Refs. 2 and 7), published peer-reviewed
literature (Refs. 8 to 10), FDA's MAUDE database, and the Medical
Device Recalls database, FDA has identified the following probable
risks to health associated with a DBT system:
(1) Corrupted or non-diagnostic images. Incorrect or delayed
diagnosis and treatment, as well as repeated x-ray radiation exposure
could occur if the
[[Page 51411]]
images are corrupted or otherwise not sufficient for diagnostic
purposes.
(2) Failure to interpret the images correctly. If a user cannot
interpret the images correctly due to poor image quality, false
positive or false negative diagnoses may result. False negative results
could result in complications, including incorrect or delayed diagnosis
of cancer and treatment; false positive results may result in
complications, such as incorrect management of the patient with
possible adverse effects, and unnecessary additional imaging and/or
invasive procedures, such as biopsy or unnecessary x-ray radiation
exposure, as well as patient anxiety.
(3) Inadequate breast coverage. Incorrect or delayed diagnosis and
treatment, as well as repeated x-ray radiation exposure could result
from an incomplete image that does not include all areas of the breast.
(4) Inappropriate breast compression. When the breast is compressed
with too much, or not enough, force and/or is not positioned properly,
patient motion, reduced image quality, reduced lesion conspicuity, and
inappropriate radiation exposure may result. Consequently, incorrect or
delayed diagnosis and treatment, as well as repeated x-ray radiation
exposure may occur.
(5) Device failure or malfunction. The absence or delay of device
output, or incorrect device output, leading to inaccurate patient
assessment and incorrect or delayed diagnosis and treatment, as well as
repeated x-ray radiation exposure, could result from a device failure
or malfunction. Additionally, electrical, thermal, or mechanical injury
may occur if, while in operation, the device discharges electricity
that could shock the user or patient; electrical discharges or exposure
to device-generated heat may cause thermal injury or discomfort; and
moving parts may cause mechanical injury.
(6) Use error or improper use of the device. Use of the device with
inappropriate image acquisition parameters, or to process images
acquired with incompatible imaging hardware or with incompatible
software, could result in incorrect or delayed diagnosis and treatment,
as well as repeated x-ray radiation exposure.
(7) Excessive x-ray exposure. Acute health effects such as erythema
(skin reddening) and epilation (hair loss) can result from excessive x-
ray exposure.
(8) Interference with other devices. The device or nearby devices
could fail to function as intended due to interference caused by
components of the device. Individuals with electrically powered
implants could experience an adverse interaction with the device due to
electromagnetic interference or radiofrequency interference.
(9) Adverse tissue reaction. A patient could experience skin
irritation and/or allergic reaction associated with the use and
operation of the device via the use of non-biocompatible materials in
patient-contacting components of the device.
(10) Infection. If validated methods and instructions for
reprocessing (i.e., cleaning or disinfecting between uses, as
necessary) of any reusable components as provided in the labeling are
not followed, the device may introduce pathogenic organisms to patients
which may result in infection.
VI. Summary of Data Upon Which Reclassification Is Based
The safety and effectiveness of this device type have become well
established since the initial approval of the first DBT system in 2011.
FDA believes that DBT systems (product code OTE) should be reclassified
from class III (premarket approval) into class II (special controls) on
the basis that special controls, in addition to general controls, can
be established to mitigate the risks to health identified in section V
and there is sufficient information to establish special controls,
which, in addition to general controls, would provide a reasonable
assurance of the safety and effectiveness of these devices. The
proposed special controls are identified by FDA in section VII of this
proposed order.
Taking into account the available evidence and the nature and known
incidence of the risks to health of the devices, FDA, on its own
initiative, is proposing to reclassify these postamendments class III
devices into class II. FDA's reasons for reclassification are based on
the scientific and clinical information available. As noted earlier,
the safety and effectiveness of this device type have become well
established since the initial approval of the first DBT system in 2011.
The Agency has gained considerable experience with DBT in the last
decade and has considered and analyzed the data from four original PMAs
and one PMA panel-track supplement for DBT systems available to FDA in
accordance with section 520(h)(4) of the FD&C Act. Further, there have
been many advancements in the field in terms of clinical research and
adoption of DBT systems as well as the development of standards,
including recognized consensus standards and guidelines (Refs. 11 to
17), which serve as important factors in shaping the Agency's knowledge
and confidence about this technology.\19\ As such, the nature of the
associated risks to health is known, and special controls can be
established to sufficiently mitigate these risks.
---------------------------------------------------------------------------
\19\ Section 514(c) of the FD&C Act states, in part, that FDA
``shall, by publication in the Federal Register . . . recognize all
or part of an appropriate standard established by a nationally or
internationally recognized standard development organization for
which a person may submit a declaration of conformity in order to
meet a premarket submission requirement or other requirement.'' More
information can be found in FDA's guidance titled ``Appropriate Use
of Voluntary Consensus Standards in Premarket Submissions for
Medical Devices,'' available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices</a>.
---------------------------------------------------------------------------
As reported in the medical literature, clinical studies evaluating
millions of women have been performed to analyze the performance of DBT
systems (Refs. 8 to 10). One of the largest systematic meta-analysis
studies to date (Ref. 8) recently compared the performance of (a) FFDM,
(b) DBT alone, (c) combined use of DBT and FFDM, and (d) combined use
of DBT and s2D. This meta-analysis analyzed 42 published studies
covering 2,606,269 patients with 13,003 cases of breast cancer. The key
metrics studied were cancer detection rate (CDR), invasive cancer
detection rate (iCDR), recall rate, and positive predictive value
(PPV1). Findings suggested that combined DBT and FFDM (6.36/1000) and
combined DBT and s2D (7.40/1000) had significantly higher CDRs than
FFDM alone (4.68/1000). DBT alone (5.20/1000) was not significantly
different from FFDM alone. Combined DBT and FFDM (4.53/1000) and
combined DBT and s2D (5.68/1000) had significantly higher iCDRs than
FFDM alone (3.42/1000). DBT alone (3.68/1000) was not significantly
different from FFDM alone. The recall rate was lowest in combined DBT
and s2D (42.3/1000) compared to FFDM alone (78.8/1000). No significant
difference was observed for DBT alone (82.4/1000) or combined DBT and
FFDM (64.6/1000) compared to FFDM alone. Positive predictive value
(PPV1) was observed to be highest in combined DBT and s2D (16.0%) and
combined DBT and FFDM (10.0%), compared to FFDM alone (7.0%). DBT alone
(7.0%) showed no improvement over FFDM alone.
This meta-analysis concluded that DBT combined with FFDM or s2D
improves cancer detection and reduces recall rates. Furthermore, the
data showed that s2D with DBT is preferred over combined DBT and FFDM
because it maintains diagnostic performance while reducing radiation
dose and costs.
[[Page 51412]]
The meta-analysis demonstrates that DBT systems perform at least as
effectively as FFDM systems across all key performance metrics--CDR,
iCDR, recall rate, and positive predictive value--with no statistically
significant differences observed.
FFDM systems with similar performance characteristics and similar
risks to health as DBT systems are currently regulated as class II
devices with special controls and have been without any significant
safety signals since 2010. FDA believes this further supports the
reclassification of DBT systems into class II and specifically supports
a determination that there is sufficient information to establish
special controls that, in addition to general controls, will provide a
reasonable assurance of safety and effectiveness. The additional
finding that DBT combined with s2D provides superior performance to
FFDM alone further supports that DBT systems, when subject to
appropriate special controls, will continue to provide appropriately
safe and effective breast cancer screening. The extensive evidence
base--encompassing more than 2.6 million patients across 42 studies--
provides sufficient data to support the proposed reclassification of
DBT systems.
Further, FDA publishes the most commonly requested national
statistics regarding the MQSA program at a recurring cadence.\20\ Based
on the statistics as of July 8, 2026, out of the 9,107 certified
facilities in the United States, 94 percent have DBT units, and 95
percent of the accredited digital 2D units within those facilities are
also accredited DBT units. As noted in section II, there remains an
absence of any major safety issues in postmarket data despite wide
adoption, which increases FDA's confidence that special controls, in
addition to general controls, are sufficient to ensure the safety and
effectiveness of DBT systems.
---------------------------------------------------------------------------
\20\ The published MQSA statistics can be found at <a href="https://www.fda.gov/radiation-emitting-products/mammography-information-patients/mqsa-national-statistics">https://www.fda.gov/radiation-emitting-products/mammography-information-patients/mqsa-national-statistics</a>.
---------------------------------------------------------------------------
The MQSA regulations established specific quality control (QC)
testing methodologies for every mammography system in the United
States. A number of national and international professional
associations, in addition to DBT system manufacturers, have now
developed QC manuals that provide uniform test procedures, performance
criteria, and minimum test frequencies that may be useful to
manufacturers and users of DBT systems in evaluating and maintaining
the performance of the device (Refs. 16 and 17). FDA's experience with
the utility of these QC manuals in evaluating and maintaining the
performance of the device provides additional confidence that special
controls can be established to provide a reasonable assurance of safety
and effectiveness of these devices.
There has also been significant development in the methods and
tools used for assessing performance of DBT systems since the first DBT
system was approved by FDA in 2011. The increasing availability and
confidence in such evaluation methods and tools support FDA's
determination that special controls, in addition to general controls,
are sufficient to provide a reasonable assurance of the safety and
effectiveness of DBT systems. Image quality measurements are essential
for evaluating whether DBT systems are adequately safe and effective.
There is now a rich body of scientific literature describing testing
methods for objectively assessing the image quality of DBT systems for
both the physical testing (Refs. 18 and 19), as well as in silico
testing (Refs. 20 to 23). Multiple workshops and special sessions have
been held at scientific conferences throughout the world to discuss
these methods to evaluate parameters of safety and effectiveness.
In November 2018 FDA held a symposium titled ``Objective Assessment
of Digital Breast Tomosynthesis Image Quality Using Anthropomorphic
Phantoms.'' During this one-day technical symposium, scientists from
FDA and other institutions discussed different approaches for assessing
the image quality of DBT systems. The focus was on objective, task-
based performance assessment of DBT systems using anthropomorphic
phantoms and use of human and model observer studies. Example
applications of the methodologies discussed were described and have
since been published in the literature (Refs. 18 to 20).
One prevailing theme that has come from these studies, workshops,
and special sessions, and from FDA's symposium is that depending on
system characteristics and modifications, these task-based performance
studies using anthropomorphic phantoms with structured background may
serve as an alternative to clinical studies (Refs.18 to 23). Such
methods have been used in lieu of clinical studies in the scientific
evaluation of these devices to support their safety and effectiveness,
which has increased FDA's confidence in developing the special controls
identified in this proposed order.
Based on our review of the information described in this proposed
order, FDA has determined that special controls, in addition to general
controls, are necessary to provide a reasonable assurance of safety and
effectiveness for DBT systems and that sufficient information exists to
establish such special controls. Therefore, FDA, on its own initiative,
is proposing to reclassify DBT systems from class III (premarket
approval) into class II (special controls), subject to premarket
notification (510(k)) requirements.
VII. Proposed Special Controls
FDA believes that DBT systems can be reclassified into class II
with the establishment of special controls. The Agency believes that
the following proposed special controls, together with general
controls, would provide reasonable assurance of the safety and
effectiveness of DBT systems intended to generate digital cross-
sectional x-ray images of the breast that can be used for the screening
and diagnosis of breast cancer for prescription use only. Table 1
demonstrates how FDA believes the proposed special controls would
mitigate each of the risks to health identified in section V.\21\
---------------------------------------------------------------------------
\21\ FDA believes it would be beneficial for sponsors that would
like more information about how to comply with the special controls
and mitigate the risks to health posed by DBT systems to submit a
Pre-Submission with a detailed description of the proposed system
hardware and software to discuss the testing plans with FDA.
Additional information may be found in FDA's guidance on Requests
for Feedback and Meetings for Medical Device Submissions: The Q-
Submission Program, available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program</a>.
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<bullet> The risk of corrupted or non-diagnostic images can be
mitigated by special controls that require performance testing,
including (1) bench testing to demonstrate the imaging characteristics
of the DBT system and (2) objective task-based assessment of diagnostic
accuracy of the DBT system conducted using human subjects, structured
physical phantoms, in silico methodologies, or a combination of these
approaches, as appropriate based on a detailed description of the
system hardware and software, as well as appropriate software
verification, validation, and hazard analysis. This risk can be further
mitigated by special controls that require clinical image
evaluation.\22\ Furthermore, informing
[[Page 51413]]
intended users in the labeling of a summary of performance testing
results and clinical image evaluation can mitigate this risk.
---------------------------------------------------------------------------
\22\ Separately from the requirements of the special controls,
physicians performing DBT clinical image evaluations must be
qualified under MQSA to interpret mammography exams. (See 21 CFR
900.12 for requirements under the MQSA relating to qualifications of
interpreting physicians). FDA also recommends that physicians
performing DBT evaluations (i) be certified by the American Board of
Radiology, American Osteopathic Board of Radiology, or the Royal
College of Physicians and Surgeons of Canada; (ii) have at least 5
years' experience following residency in diagnostic radiology with
at least 50 percent of each year's practice in breast imaging and
have had training in clinical image quality equivalent to that
provided by the FDA-approved accreditation bodies; and (iii) be
currently using a DBT system at an MQSA or VAH-certified facility.
---------------------------------------------------------------------------
[cir] Examples of bench tests that may be used to demonstrate the
imaging characteristics of a DBT system and mitigate this risk to
health include (see Refs. 11 to 13 for more detail on recognized
consensus standard methods for performing these tests):
[ssquf] Spatial Resolution,
[ssquf] Noise Analysis,
[ssquf] Signal-to-Noise Ratio transfer--Detective Quantum
Efficiency (DQE),
[ssquf] Detector Lag,
[ssquf] Automatic Exposure Control (AEC) Performance,
[ssquf] Geometric Distortion,
[ssquf] Missed tissue at top and bottom of reconstructed DBT
volume,
[ssquf] Missed tissue at chest wall side in reconstructed DBT
volume,
[ssquf] Testing of Alignment and Collimation, and
[ssquf] Radiation Dosimetry.
[cir] Objective task-based assessment of diagnostic accuracy can be
conducted through one or more of the following methodologies to
mitigate this risk to health:
[ssquf] Reader study with human subjects, defined as a study in
which readers review and interpret patient images acquired from a DBT
system for a specified task, and task performance of the readers is
measured to evaluate the effectiveness of the DBT system.
[ssquf] Observer study with structured physical phantoms, defined
as an objective task-based assessment of performance for the DBT system
using structured phantoms similar to published methods described in the
literature (Refs. 18 and 19).
[ssquf] In silico Trials (IST) also referred to as Virtual Clinical
Trials (VCT), defined as a study to provide estimates of the
performance of a DBT system based on computational modeling in a
virtual population for a clinical task of interest and within a
specific context of use (Refs. 20 to 24).
<bullet> The risk of failure to interpret the images correctly due
to poor image quality (the risk of false positive and false negative
results) can be mitigated by special controls that require
demonstrating the performance characteristics of the device across a
representative range of settings in screening and diagnosis of breast
cancer. The device can be evaluated using performance testing, which
includes bench testing and objective task-based assessment of
diagnostic accuracy of the DBT system, as previously described, to
mitigate the risk to health of ``corrupted or non-diagnostic images.''
This risk can be further mitigated by special controls that require
clinical image evaluation. Informing intended users in the labeling of
a description of the qualifications and/or clinical training needed for
the safe use of the device and a summary of performance testing results
and clinical image evaluation can further mitigate this risk.
<bullet> The risk of inadequate breast coverage can be mitigated by
special controls that require some elements of performance testing,
specifically bench testing \23\ to demonstrate the imaging
characteristics of the DBT system as well as clinical image evaluation.
This risk can be further mitigated with a description of the
qualifications and/or clinical training needed for the safe use of the
device and a summary of performance testing and clinical image
evaluation in the labeling.
---------------------------------------------------------------------------
\23\ The following bench tests may generally be appropriate in
addressing this special control: missed tissue at top and bottom of
reconstructed DBT volume, missed tissue at chest wall side in
reconstructed DBT volume, and alignment and collimation.
---------------------------------------------------------------------------
<bullet> The risk of inappropriate breast compression can be
mitigated by special controls that require some elements of performance
testing, specifically bench testing \24\ to demonstrate the imaging
characteristics of the DBT system, and software verification,
validation, and hazard analysis, and clinical image evaluation. This
risk can be further mitigated with a description of the qualifications
and/or clinical training needed for the safe use of the device and a
summary of performance testing and clinical image evaluation in the
labeling.
---------------------------------------------------------------------------
\24\ The following bench tests may generally be appropriate in
addressing this special control: missed tissue at chest wall side in
reconstructed DBT volume and AEC performance.
---------------------------------------------------------------------------
<bullet> The risk of device failure or malfunction can be mitigated
by special controls that require some elements of performance testing,
specifically bench testing, to demonstrate the imaging characteristics
of the DBT system, appropriate software verification, validation, and
hazard analysis, and electrical safety/electromagnetic compatibility
(EMC) testing. Additionally, this risk can be further mitigated with
quality control testing recommendations in the labeling.
<bullet> The risk of use error or improper device use can be
mitigated by special controls that require appropriate software
verification, validation, and hazard analysis as well as a detailed
description of the device and its outputs and a description of the
qualifications and/or clinical training needed for the safe use of the
device in the labeling.
<bullet> The risk of excessive x-ray radiation exposure can be
mitigated by special controls that require some elements of performance
testing, specifically bench testing \25\ to demonstrate the imaging
characteristics of the DBT system as well as appropriate software
verification, validation, and hazard analysis and electrical safety/EMC
testing. This risk can be further mitigated with a description of the
qualifications and/or clinical training needed for the safe use of the
device in the labeling.
---------------------------------------------------------------------------
\25\ The following bench tests may generally be appropriate in
addressing this special control: DQE, AEC performance, alignment and
collimation, and radiation dosimetry.
---------------------------------------------------------------------------
<bullet> The risk of device failure to function as intended due to
interference with other devices due to radiofrequency or
electromagnetic interference can be mitigated by special controls
requiring testing that demonstrates EMC.
<bullet> The risk of adverse tissue reaction for patient-contacting
components can be mitigated by special controls requiring that
components of the device that may contact the patient be demonstrated
to be biocompatible.
<bullet> The risk of infection from patient-contacting devices can
be mitigated by special controls that require labeling that includes
validated instructions for cleaning and disinfecting equipment surfaces
that contact the patient.
[[Page 51414]]
Table 1--Risks to Health and Mitigation Measures for a DBT System
------------------------------------------------------------------------
Identified risks to health Mitigation measures
------------------------------------------------------------------------
Corrupted or non-diagnostic images..... Performance testing, Software
verification, validation, and
hazard analysis, Clinical
image evaluation, Labeling.
Failure to interpret the images Performance testing, Clinical
correctly, leading to false negative image evaluation, Labeling.
or false positive results.
Inadequate breast coverage............. Performance testing, Clinical
image evaluation, Labeling.
Inappropriate breast compression....... Performance testing, Software
verification, validation, and
hazard analysis, Clinical
image evaluation, Labeling.
Device failure or malfunction.......... Performance testing, Software
verification, validation, and
hazard analysis, Electrical
safety/EMC testing, Labeling.
Use error/improper use of the device... Software verification,
validation, and hazard
analysis, Labeling.
Excessive x-ray radiation exposure..... Performance testing, Software
verification, validation, and
hazard analysis, Electrical
safety/EMC testing, Labeling.
Device or nearby devices failure to Electrical safety/EMC testing.
function as intended due to
interference.
Adverse tissue reaction................ Biocompatibility evaluation.
Infection.............................. Labeling.
------------------------------------------------------------------------
If this proposed order is finalized, DBT systems will be
reclassified into class II (special controls) and will be subject to
premarket notification requirements under section 510(k) of the FD&C
Act. As discussed in this proposed order, the intent is for the
reclassification to be codified in the new classification regulation 21
CFR 892.1717. If finalized, DBT systems will be required to comply with
the particular mitigation measures set forth in the special controls.
In addition, FDA is proposing that these devices be for prescription
use only. Prescription devices are exempt from the requirement for
adequate directions for use for the layperson under section 502(f)(1)
of the FD&C Act and Sec. 801.5, as long as the conditions of Sec.
801.109 are met. Adherence to the proposed special controls, in
addition to the general controls, is necessary to provide a reasonable
assurance of the safety and effectiveness of the devices.
VIII. 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.
IX. Paperwork Reduction Act of 1995
While this proposed order contains no new collections of
information, it does refer to previously approved FDA collections of
information. The previously approved collections of information are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The
collections of information in 21 CFR part 820 (Quality Management
System Regulation) have been approved under OMB control number 0910-
0073; the collections of information in 21 CFR part 807, subpart E
(Premarket Notification Procedures) have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
801 (Device Labeling) have been approved under OMB control number 0910-
0485; and the collections of information in 21 CFR part 814, subparts A
through E (Premarket Approval (PMA) of Medical Devices) have been
approved under OMB control number 0910-0231.
X. Proposed Effective Date
FDA proposes that any final order based on this proposed order
become effective 30 days after its date of publication in the Federal
Register.
XI. Codification of Orders
Under section 513(f)(3) of the FD&C Act, FDA may issue final orders
to reclassify devices. FDA will continue to codify classifications and
reclassifications in the Code of Federal Regulations (CFR). Changes
resulting from final orders will appear in the CFR as newly codified
orders. Therefore, under section 513(f)(3) of the FD&C Act, in the
proposed order, we are proposing to codify digital breast tomosynthesis
system in the new 21 CFR 892.1717, under which DBT systems would be
reclassified from class III into class II.
XII. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they are also available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on public
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. Although FDA has verified the website
addresses as of the date this document publishes in the Federal
Register, websites are subject to change over time.
* 1. FDA, Premarket Approval for P080003. Available at: <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080003">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080003</a>.
* 2. FDA, 2010 Meeting Materials of the Radiological Devices Panel.
Available at: <a href="https://wayback.archive-it.org/7993/20170403223419/https:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/RadiologicalDevicesPanel/ucm226660.htm">https://wayback.archive-it.org/7993/20170403223419/https:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/RadiologicalDevicesPanel/ucm226660.htm</a>.
* 3. FDA, Premarket Approval for P130020. Available at: <a href="https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130020B.pdf">https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130020B.pdf</a>.
* 4. FDA, Premarket Approval for P140011. Available at: <a href="https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140011B.pdf">https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140011B.pdf</a>.
* 5. FDA, Premarket Approval for P160031. Available at: <a href="https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160031B.pdf">https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160031B.pdf</a>.
* 6. FDA, Premarket Approval for P080003/S001. Available at: <a href="https://www.accessdata.fda.gov/cdrh_docs/pdf8/P080003S001B.pdf">https://www.accessdata.fda.gov/cdrh_docs/pdf8/P080003S001B.pdf</a>.
* 7. FDA, 2012 Meeting Materials of the Radiological Devices Panel.
Available at: <a href="https://wayback.archive-it.org/7993/20170403223422/https:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/RadiologicalDevicesPanel/ucm299053.htm">https://wayback.archive-it.org/7993/20170403223422/https:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/RadiologicalDevicesPanel/ucm299053.htm</a>.
8. Alabousi, M., W. Akshay, K. Mohammed, et al. ``Performance of
Digital Breast Tomosynthesis, Synthetic Mammography, and Digital
Mammography in Breast Cancer Screening: A Systematic Review and
[[Page 51415]]
Meta-Analysis,'' JNCI: Journal of the National Cancer Institute,
113(6):680-690, 2021, <a href="https://doi.org/10.1093/jnci/djaa205">https://doi.org/10.1093/jnci/djaa205</a>.
9. Houssami, N., S. Zackrisson, K. Blazek, et al. ``Meta-Analysis of
Prospective Studies Evaluating Breast Cancer Detection and Interval
Cancer Rates for Digital Breast Tomosynthesis Versus Mammography
Population Screening,'' European Journal of Cancer, 148:14-23, 2021,
<a href="https://doi.org/10.1016/j.ejca.2021.01.035">https://doi.org/10.1016/j.ejca.2021.01.035</a>.
10. Marinovich, M.L., K.E. Hunter, P. Macaskill, et al. ``Breast
Cancer Screening Using Tomosynthesis or Mammography: A Meta-Analysis
of Cancer Detection and Recall,'' JNCI: Journal of the National
Cancer Institute, 110(9):942-949, 2018, <a href="https://doi.org/10.1093/jnci/djy121">https://doi.org/10.1093/jnci/djy121</a>.
11. IEC 61223-3-6 ``Evaluation and Routine Testing in Medical
Imaging Departments--Part 3-6: Acceptance and Constancy Tests--
Imaging Performance of Mammographic X-Ray Equipment Used in a
Mammographic Tomosynthesis Mode of Operation,'' <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=45755">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=45755</a>.
12. IEC 60601-2-45 ``Medical Electrical Equipment--Part 2-45:
Particular Requirements for the Basic Safety and Essential
Performance of Mammographic X-Ray Equipment and Mammographic
Stereotactic Devices,'' <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=37174">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=37174</a>.
13. IEC 62220-1-2 ``Medical Electrical Equipment--Characteristics of
Digital X-Ray Imaging Devices--Part 1-2: Determination of the
Detective Quantum Efficiency--Detectors Used in Mammography,''
<a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=28636">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=28636</a>.
* 14. American College of Radiology, ``ACR Practice Parameter for
the Performance of Screening and Diagnostic Mammography,'' 2023,
<a href="https://gravitas.acr.org/PPTS/GetDocumentView?docId=8">https://gravitas.acr.org/PPTS/GetDocumentView?docId=8</a>.
* 15. American College of Radiology, ``ACR Practice Parameter for
the Performance of Screening and Diagnostic (DBT),'' 2023, <a href="https://gravitas.acr.org/PPTS/GetDocumentView?docId=7">https://gravitas.acr.org/PPTS/GetDocumentView?docId=7</a>.
* 16. American College of Radiology, 2018 Digital Mammography
Quality Control Manual, Rev. 2nd Ed., May 2020, <a href="https://edge.sitecorecloud.io/americancoldf5f-acrorgf92a-productioncb02-3650/media/ACR/Files/Clinical/Quality-Control-Manuals/Mammography-Quality-Control-Manual.pdf">https://edge.sitecorecloud.io/americancoldf5f-acrorgf92a-productioncb02-3650/media/ACR/Files/Clinical/Quality-Control-Manuals/Mammography-Quality-Control-Manual.pdf</a>.
* 17. European Reference Organisation for Quality Assured Breast
Screening and Diagnostic Services, ``European Guidelines for Quality
Assurance in Breast Cancer Screening and Diagnosis,'' 2023, <a href="https://euref.org/download/european-guidelines-for-quality-assurance-in-breast-cancer-screening-and-diagnosis-pdf-2/">https://euref.org/download/european-guidelines-for-quality-assurance-in-breast-cancer-screening-and-diagnosis-pdf-2/</a>.
18. Ikejimba, L.C., J. Salad, C.G. Graff, et al. ``Assessment of
Task-Based Performance from Five Clinical DBT Systems Using an
Anthropomorphic Breast Phantom,'' Medical Physics, 48(3):1026-1038,
2021, <a href="https://doi.org/10.1002/mp.14568">https://doi.org/10.1002/mp.14568</a>.
19. Cockmartin, L., N.W. Marshall, G. Zhang, et al. ``Design and
Application of a Structured Phantom for Detection Performance
Comparison Between Breast Tomosynthesis and Digital Mammography,''
Physics in Medicine & Biology, 62:758-780, 2017, <a href="https://doi.org/10.1088/1361-6560/aa5407">https://doi.org/10.1088/1361-6560/aa5407</a>.
* 20. Badano, A., C.G. Graff, A. Badal, et al. ``Evaluation of
Digital Breast Tomosynthesis as Replacement of Full-Field Digital
Mammography Using an In Silico Imaging Trial,'' JAMA Network Open,
1(7), 2018, doi:10.1001/jamanetworkopen.2018.5474, <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2717000">https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2717000</a>.
21. Kiarashi, N., L.W. Nolte, J.Y. Lo, et al. ``Impact of Breast
Structure on Lesion Detection in Breast Tomosynthesis, a Simulation
Study,'' Journal of Medical Imaging, 3(3):035504, 2016, <a href="https://doi.org/10.1117/1.JMI.3.3.035504">https://doi.org/10.1117/1.JMI.3.3.035504</a>.
22. Barufaldi, B., T.L. Vent, P.R. Bakic, et al. ``Computer
Simulations of Case Difficulty in Digital Breast Tomosynthesis Using
Virtual Clinical Trial,'' Medical Physics, 49:2220-2232, 2022,
<a href="https://doi.org/10.1002/mp.15553">https://doi.org/10.1002/mp.15553</a>.
23. Marshall, N.W., and H. Bosmans. ``Performance Evaluation of
Digital Breast Tomosynthesis Systems: Comparison of Current Virtual
Clinical Trial Methods,'' Physics in Medicine & Biology,
67(22):TR04, 2022, <a href="https://doi.org/10.1088/1361-6560/ac9a34">https://doi.org/10.1088/1361-6560/ac9a34</a>.
* 24. FDA, ``Assessing the Credibility of Computational Modeling and
Simulation in Medical Device Submissions--Guidance for Industry and
Food and Drug Administration Staff, 2023. Available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions</a>.
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, it is
proposed that 21 CFR part 892 be amended as follows:
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. 892.1717 to subpart B to read as follows:
Sec. 892.1717 Digital breast tomosynthesis system.
(a) Identification. A digital breast tomosynthesis system is a
prescription device that is intended to generate digital cross-
sectional x-ray images of the breast that can be used for the screening
and diagnosis of breast cancer. This device may include acquisition
hardware and software, digital image receptor, acquisition workstation,
automatic exposure control, image processing and reconstruction
programs, compression system, patient and equipment support devices,
and components.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Performance testing data must include:
(i) Data to demonstrate the performance characteristics of the
device across a representative range of settings in screening and
diagnosis of breast cancer through the following:
(A) Bench testing to demonstrate the imaging characteristics of the
device and associated radiation dose levels.
(B) Objective task-based assessment of diagnostic accuracy of the
device, conducted using human subjects, structured physical phantoms,
or in silico methodologies, or a combination of these approaches.
(ii) Detailed description of the system hardware and software,
which includes acquisition hardware and software, image receptor,
acquisition workstation, automatic exposure control, image processing
and reconstruction programs, patient and equipment supports, component
parts, and accessories.
(2) Clinical image evaluation data must demonstrate the images are
of sufficiently acceptable quality for screening and diagnosis of
breast cancer.
(3) Software verification, validation, and hazard analysis must be
performed.
(4) Data must demonstrate the electrical safety, mechanical safety,
thermal safety, and electromagnetic compatibility (EMC) of the device
in the intended use environment.
(5) Patient-contacting components of the device must be
demonstrated to be biocompatible.
(6) Labeling must include the following:
(i) A detailed device description including principles of
operation, system hardware and software, which include acquisition
hardware and software, image receptor, acquisition workstation,
technique factors, automatic exposure control, image processing and
reconstruction programs,
[[Page 51416]]
patient and equipment supports, component parts, and accessories.
(ii) A detailed description of the device outputs.
(iii) User qualifications and/or clinical training needed for the
safe use of the device.
(iv) A detailed summary of the objective task-based diagnostic
accuracy assessment, including test methods, dataset characteristics,
results, and a summary of sub-analyses on case distributions stratified
by relevant confounders.
(v) A detailed summary of bench testing results, including graphs
or tables as appropriate.
(vi) A detailed summary of the clinical image evaluation performed
with the device.
(vii) A description of quality control testing, including detailed
procedures for performing these tests, if applicable, and the frequency
of testing.
(viii) Validated methods and instructions for cleaning and
disinfection of any reusable patient-contacting components.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-16209 Filed 8-7-26; 8:45 am]
BILLING CODE 4164-01-P
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