[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Rules and Regulations]
[Pages 15126-15171]
[FR Doc No: 2023-04550]

Vol. 88

Friday,

No. 47

March 10, 2023

Part II

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Part 900

Mammography Quality Standards Act; Final Rule

Federal Register / Vol. 88, No. 47 / Friday, March 10, 2023 / Rules
and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 900

[Docket No. FDA-2013-N-0134]
RIN 0910-AH04

Mammography Quality Standards Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
issuing a final rule to update the mammography regulations that were
issued under the Mammography Quality Standards Act of 1992 (MQSA) and
the Federal Food, Drug, and Cosmetic Act (FD&C Act). We are issuing
updates to modernize the regulations by incorporating current science
and mammography best practices. These updates are intended to improve
the delivery of mammography services by strengthening the communication
of healthcare information; allowing for more informed decision making
by patients and providers (by requiring facilities to provide them with
additional health information); helping to ensure the availability of
qualified mammography personnel; bolstering the medical outcomes audit
to provide feedback to improve mammography interpretations; modernizing
technological aspects of the standards; and adding additional tools to
deal with noncompliant facilities.

DATES: This rule is effective on September 10, 2024.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule 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: Preetham Sudhaker, Division of
Mammography Quality Standards (DMQS), Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Legal Authority
    C. Summary of the Major Provisions of the Final Rule
    D. Costs and Benefits of the Final Rule
II. Table of Abbreviations and Acronyms Commonly Used in This
Document
III. Background
    A. Need for Amendments to Mammography Regulations
    B. Summary of Comments to the Proposed Rule
    C. General Overview of the Final Rule's Changes From the
Proposed Rule
IV. Legal Authority
V. Comments to the Proposed Rule and FDA's Responses
    A. General Comments on the Proposed Rule
    B. Scope of MQSA Regulations
    C. Repeated Failure To Achieve Accreditation
    D. Retention and Release of Personnel Records
    E. Digital Accessories
    F. Facility Identification Information in Mammography Report and
Lay Summary
    G. Final and Incomplete Assessments and Lay Summaries
    H. Deadlines for Mammography Reports
    I. Breast Density Notification--General Support for Density
Notification
    J. Breast Density Notification Language
    K. Breast Density Notification and the Role of the Referring
Healthcare Provider
    L. Format for Image Interpretation, Retention, Transfer of
Original Images, and Release of Copies
    M. Deadlines for Image Transfer and the Release of Copies
    N. Facility Closure and Mammography Record Retention
    O. Mammography Medical Outcomes Audit
    P. Patient and Referring Provider Notification
    Q. Revocation of Certification
    R. Interpreting Physician Qualifications, Including Continuing
Experience
    S. Cleaning of Mammography Equipment
    T. Availability and Clinical Role of Breast Imaging Modalities,
Screening Mammography Guidelines
    U. Clinical Decision-Making
    V. Insurance Coverage
    W. Economic Impact of This Rule
    X. Federalism and the Relationship Between Federal and State
Breast Density Reporting Requirements
    Y. Effective Date of This Rule
    Z. Miscellaneous Comments
VI. Effective Date and Compliance Date
VII. Economic Analysis of Impacts
    A. Introduction
    B. Summary and Accounting Statement
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose of the Final Rule

    Mammography is an x-ray imaging examination used to identify signs
of breast cancer. For patients to receive the full benefit of
mammography, the service must be of high quality, including performance
of the examination by qualified technologists, using equipment that is
tested and properly functioning; interpretation by qualified
physicians; and clear and prompt communication of results to patients
and their referring healthcare providers. The MQSA establishes uniform
baseline Federal standards designed to ensure, among other things, that
all patients nationwide have access to quality mammography services.
The MQSA implementing regulations address, among other things,
standards for accreditation bodies and certifying agencies and
mammography quality standards for facilities, such as qualifications of
personnel at mammography facilities, standards for mammography
equipment, the content and terminology for mammography reports, the
requirement to establish a quality assurance program, standards and
timing for quality assurance testing, standards for clinical image
quality, recordkeeping, communication of results, and clinical image
review by the facility's accrediting body. Based on technology changes
in mammography and our experience with the administration of the MQSA
program, FDA is modernizing and updating the regulations as well as
improving the information, including breast density information,
provided by mammography facilities to patients and their healthcare
providers. This final rule requires that the summary of the mammography
report written in lay terms (``lay summary'') that is provided to
patients identifies whether the patient has dense or non-dense breast
tissue and includes a prescribed paragraph on the significance of
breast density. The rule also establishes four categories for reporting
breast tissue density in the mammography report that is provided to the
patient's referring healthcare provider.

B. Legal Authority

    The MQSA was enacted on October 27, 1992, and is codified, as
amended in 1998 and 2004, under section 354 of the Public Health
Service (PHS) Act. Public Law 102-539, 2, 106 (1992), codified as
amended at 42 U.S.C. 263b. Under the MQSA, all mammography facilities,
except facilities of the Department of Veterans Affairs (VA), must be
accredited by an approved accreditation body (AB) and certified by FDA
(or an approved State certification agency) to provide mammography
services. FDA is amending the mammography regulations established under
the PHS Act, and sections of the FD&C Act.

C. Summary of the Major Provisions of the Final Rule

    FDA is making three categories of improvements to our mammography
regulations: improvements that address changes in mammography
technology; improvements that enhance enforcement of quality standards;
and improvements in the way mammography results are categorized,
reported, retained, and transferred to patients and healthcare
providers. Specifically, in this final rule FDA is making the following
amendments:
     New and amended provisions related to technology that,
among other things, update several equipment and quality control
provisions in the regulations to address current technology, including
digital mammography;
     Improvements that enhance enforcement that, among other
things:
    [cir] Require that mammograms submitted for interpretation be
presented in the mammographic modality in which they were originally
produced, and not be copied or digitized from hardcopy original images,
which could adversely affect the accuracy of interpretation;
    [cir] Prohibit accreditation bodies from accepting an application
for accreditation from a facility that has failed to become accredited
after three consecutive attempts until 1 year after the most recent
accreditation failure;
    [cir] Expressly state that a facility's certificate may be
suspended or revoked due to a failure to comply with requests by FDA,
the State certification agency, or the AB for records, including
clinical images for an additional mammography review (AMR), or with
requests by current or former facility personnel for records
documenting their qualifications;
    [cir] Add the State certification agency as an entity that may
initiate an AMR, which can help detect quality issues, and also to
state expressly that FDA and the State certification agency can notify
patients and their providers individually or through the mass media
when a facility is unable or unwilling to perform a required patient
and referring physician notification (PPN), which would help to ensure
that patients and providers are informed of serious risks to human
health resulting from mammography that fails to meet quality standards;
    [cir] Require that, before a facility closes or no longer provides
mammography services, it must make arrangements for access by patients
and healthcare providers to mammography images and reports; and
    [cir] Require facilities to provide personnel with copies of their
MQSA qualification records, which are often needed to work at
additional or new facilities.
     Improvements in the way mammography results are
categorized, reported, retained, and transferred to patients and
healthcare providers that, among other things:
    [cir] Require that the mammographic examination report include the
facility name and location (at a minimum, the city, State, ZIP code,
and telephone number of the facility), in order to help to ensure that
healthcare providers can obtain the necessary information to enable
them to assist patients in making informed healthcare decisions;
    [cir] Change the explanatory language in one final assessment
category (``Benign'') to promote greater consistency and accuracy in
the use of the category, and add three new categories of mammographic
assessment to the existing categories in the regulations, which will
allow mammography facilities to precisely classify and communicate
findings;
    [cir] Add a specific, required timeframe for facilities to send
mammography reports to healthcare providers and the summary written in
lay terms to patients whose mammograms have either ``Suspicious'' or
``Highly Suggestive of Malignancy'' final assessment categories, which
could lead to earlier definitive tissue diagnosis of malignancy and
earlier start of treatment, and avoid, for the patient, the anxiety of
a protracted waiting period;
    [cir] Require reporting to patients and healthcare providers to
include an assessment of breast density, in order to provide them with
additional information about their mammography and the potential
limitations of their mammogram results so that patients and their
healthcare providers can make informed healthcare decisions by;
    [ssquf] Retaining the two categories of density in the patient lay
summary, but changing the wording from the comparative terms ``high
density'' and ``low density'' to ``dense'' and ``not dense,'' in order
to align with clinical practice and improve clarity to the patient.
    [ssquf] Revising the written lay summary of the results provided to
the patient to contain one of the following breast density notification
statements. The non-dense breast notification (see Sec.
900.12(c)(2)(iii) in this final rule) now states, ``Breast tissue can
be either dense or not dense. Dense tissue makes it harder to find
breast cancer on a mammogram and also raises the risk of developing
breast cancer. Your breast tissue is not dense. Talk to your healthcare
provider about breast density, risks for breast cancer, and your
individual situation.'' The dense breast notification (see Sec.
900.12(c)(2)(iv) in this final rule) now states, ``Breast tissue can be
either dense or not dense. Dense tissue makes it harder to find breast
cancer on a mammogram and also raises the risk of developing breast
cancer. Your breast tissue is dense. In some people with dense tissue,
other imaging tests in addition to a mammogram may help find cancers.
Talk to your healthcare provider about breast density, risks for breast
cancer, and your individual situation.''
    [ssquf] Requiring that the written report of the results of the
mammographic examination provided to the healthcare provider include
information concerning an overall assessment of breast density,
classified in one of the following categories: (A) ``The breasts are
almost entirely fatty.'' (B) ``There are scattered areas of
fibroglandular density.'' (C) ``The breasts are heterogeneously dense,
which may obscure small masses.'' (D) ``The breasts are extremely
dense, which lowers the sensitivity of mammography.''
    [cir] Require each mammography facility to implement policies and
procedures to minimize the loss of mammography images and reports
because the loss of these records can have a significant, negative
impact on clinical care, and also specify the timeframe within which
facilities must transfer original mammograms and copies of reports to
patients, healthcare providers, and others because delays in the
transfer of these records can lead to delays in diagnosis or treatment;
and
    [cir] Clarify the minimum information that facilities must collect
during the mammography medical outcomes audit because calculating and
tracking these values is important to the evaluation of accuracy in
detecting breast cancer, allowing facilities and interpreting
physicians to review their performance and enact quality improvement
measures.

D. Costs and Benefits of the Final Rule

    The quantified benefits of this rule are derived from reduced
mortality and breast cancer treatment costs resulting from the breast
density reporting requirements. The estimate of annualized benefits
over 10 years ranges from $12.99 million to $232.69 million at a 7
percent discount rate and $8.50 million to $266.09 million at a 3
percent discount rate. Other benefits that we are not able to quantify
include reduced cancer morbidity and improvements in the accuracy of
mammography by

improving quality control and strengthening the medical audit. The
costs of the final rule include costs to mammography facilities to
comply with the requirements and costs associated with supplemental
testing and biopsies resulting from the breast density requirements.
The estimate of annualized costs over 10 years ranges from $28.87
million to $45.42 million at a 7 percent discount rate with a primary
value of $36.31 million. Using a 3 percent discount rate, the
annualized costs range from $27.61 million to $44.16 million with a
primary value of $35.05 million.

II. Table of Abbreviations and Acronyms Commonly Used in This Document

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   Abbreviation or acronym                   What it means
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AB...........................  Accreditation Body.
ACR..........................  American College of Radiology.
ACS..........................  American Cancer Society.
AMR..........................  Additional Mammography Review.
BICOE........................  Breast Imaging Centers of Excellence.
BI-RADS......................  Breast Imaging--Reporting and Data
                                System.
CAD..........................  Computer-Aided Detection.
CD...........................  Compact Discs.
CDC..........................  Centers for Disease Control and
                                Prevention.
CDR..........................  Cancer Detection Rate.
CDRH.........................  Center for Devices and Radiological
                                Health.
CFR..........................  Code of Federal Regulations.
CRCPD........................  Conference of Radiation Control Program
                                Directors, Inc..
DBT..........................  Digital Breast Tomosynthesis.
DICOM........................  Digital Imaging and Communication in
                                Medicine.
DMQS.........................  Division of Mammography Quality
                                Standards.
ERG..........................  Eastern Research Group.
FDA, Agency, or we...........  Food and Drug Administration.
FD&C Act.....................  Federal Food, Drug, and Cosmetic Act.
FFDM.........................  Full-Field Digital Mammography.
FRIA.........................  Final Regulatory Impact Analysis.
HIPAA........................  Health Insurance Portability and
                                Accountability Act of 1996.
IP...........................  Interpreting Physician.
MBI..........................  Molecular Breast Imaging.
MQSA.........................  Mammography Quality Standards Act of
                                1992.
MQSRA........................  Mammography Quality Standards
                                Reauthorization Acts of 1998 and 2004.
MRI..........................  Magnetic Resonance Imaging.
NAPBC........................  National Accreditation Program for Breast
                                Centers.
NMQAAC.......................  National Mammography Quality Assurance
                                Advisory Committee.
OMB..........................  Office of Management and Budget.
PACS.........................  Picture Archiving and Communication
                                System.
PGHS.........................  Policy Guidance Help System.
PHS Act......................  Public Health Service Act.
PPN..........................  Patient and Referring Physician
                                Notification.
PPV..........................  Positive Predictive Value.
QC...........................  Quality Control.
QI...........................  Quality Indicator.
SCA..........................  State Certification Agency.
U.S.C........................  United States Code.
USPSTF.......................  U.S. Preventive Services Task Force.
VA...........................  Department of Veterans Affairs.
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III. Background

    According to the Centers for Disease Control and Prevention (CDC),
in 2018, the most recent year for which numbers are available, over
254,000 women were diagnosed with breast cancer, and more than 42,000
women died of the disease (Ref. 1). According to the National Cancer
Institute of the National Institutes of Health, in 2020, over 276,000
women were projected to be diagnosed with breast cancer, and over
42,000 women were projected to die of the disease (Ref. 2). Breast
cancer is rare in men, with approximately 2,300 new cases and 500
deaths reported in the United States in 2017, according to the CDC
(Ref. 3). Among women, however, breast cancer is now the most common
non-skin cancer and the second leading cause of cancer deaths after
lung cancer (Ref. 4). There are also disparities in both the incidence
of breast cancer, and in mortality from breast cancer, by both race and
ethnicity. In 2019, the latest year for which incidence data are
available, in the United States, 30,450 new cases of breast cancer were
reported among Black, Non-Hispanic women, and 6,600 Black, Non-Hispanic
women died of this cancer. For every 100,000 Black, Non-Hispanic women,
128 new breast cancer cases were reported and 28 Black, Non-Hispanic
women died of this cancer (Ref. 1). Health disparity and equity
considerations may exist as they relate to mammography practice and
density notification, and we have considered sociodemographic
differences in mammography practice and outcomes. This final rule
provides standard requirements that help to ensure that all patients
and providers receive complete and consistent breast density
information in mammography reports.
    Early detection of female breast cancer, typically involving
mammography, is the best means of preventing deaths that can result if
the diagnosis is delayed until the onset of more advanced symptoms
(Ref. 5). Mammography is a type of medical imaging that uses x-rays to
create images (mammograms) of the internal structures of the breasts.
There are three types of mammography referred to in

this document: screen-film mammography, full field digital mammography,
and digital breast tomosynthesis. In screen-film mammography, x-rays
are transmitted through the breast and expose a sheet of x-ray film
enclosed in a cassette. In full field digital mammography, the x-rays
go through to an image receptor that is a radiation-sensitive
electronic device or plate. Images are displayed on a computer
workstation, and can, for example, be digitally magnified. Digital
breast tomosynthesis also uses an electronic image receptor and a
computer workstation, and obtains multiple images at different angles
around the breast, then uses a computer to reconstruct a series of
parallel images that resemble slices through the breast.
    Mammography can help detect breast cancer in its earliest, most
treatable stages, when it is too small to be felt or detected by any
other method (Ref. 6).
    However, as noted by the Government Accountability Office (GAO), a
mammogram is among the most difficult radiographic images to interpret
(Ref. 7). The mammogram must be of high quality for accurate image
interpretation. If the image quality is poor, the interpreter may miss
a cancerous lesion. Such a false negative diagnosis could delay
treatment and result in an avoidable death or increased morbidity. It
is equally true that poor quality images or inaccurate interpretations
can lead to a false positive diagnosis when normal tissue is
misinterpreted as abnormal. This could lead to needless anxiety for the
patient, costly additional testing, and unnecessary biopsies.

A. Need for Amendments to Mammography Regulations

    Most of the requirements in our mammography regulations are over 20
years old. As described below and in the proposed rule (84 FR 11669,
March 28, 2019), major developments in understanding relating to the
importance of certain breast anatomy on breast cancer risk have
occurred, and FDA believes these developments should be reflected in
our nationwide standard. In addition, we are updating our mammography
regulations in response to several gaps that we have identified as we
have implemented the current regulations. Current regulations do not
require that a notification of breast density be part of the report
provided to the healthcare provider or the lay summary provided to the
patient. However, there is increasing interest in breast density
reporting, and States are taking action. Between 2009 and June 2021, 38
States have passed laws mandating notification of breast density (Ref.
8). These State laws impose requirements that vary from State to State.
To ensure all patients receive breast density information from their
mammograms, and that such required baseline information is consistent,
FDA is amending the mammography reporting requirements to require that
the written report of the results of the mammographic examination
provided to the healthcare provider and the lay summary of the results
provided to the patient also include information concerning patient
breast density. FDA is also requiring that both the mammography report
and lay summary include basic mammography facility identification
information. Technology has also advanced since the regulations were
issued, so the amended regulations will make changes to reflect current
mammography best practices and technologies.

B. Summary of Comments to the Proposed Rule

    In the Federal Register of March 28, 2019, FDA published a rule
proposing amendments to the MQSA regulations. The comment period for
the proposed rule closed on June 26, 2019. FDA received many comments
on the proposed rule from several entities including medical device
associations, industry, medical and healthcare professional
associations, public health advocacy groups, law firms, and
individuals. While several comments object to particular sections or
subsections of the proposed rule, almost all comments voice support for
the objective intent of the proposed rule, to establish updates to
modernize the MQSA regulations to incorporate current science and
mammography best practices.
    Some comments raise concerns or request clarification regarding:
     the scope of the MQSA regulations,
     failure of facility accreditation,
     retention of personnel records,
     mammography reports (including assessment categories) and
lay summaries,
     breast density notification to patients and referring
providers,
     requirements for image retention, transfer of original
images, and release of copies,
     the mammography medical outcomes audit,
     patient and provider notification,
     the availability and use of various imaging modalities,
and
     issues related to clinical decision-making.

C. General Overview of the Final Rule's Changes From the Proposed Rule

    FDA considered all comments received on the proposed rule and made
changes, primarily for clarity and accuracy and to improve
understanding of breast density notification language to healthcare
providers and patients. On its own initiative, FDA is also making minor
technical changes to make the withdrawal provisions clearer. The
changes from the proposed rule include the following significant
revisions, additions, and removals to the codified section:
     add or substitute the term ``provider'' or ``healthcare
provider'' in several paragraphs in place of references to referring
physician (Sec. Sec.  900.2(c)(2), 900.2(k), 900.2(ii),
900.4(f)(1)(ii)(B), and 900.12(j)),
     revise language to clarify that no AB shall accept an
application for accreditation from a facility that has had three
consecutive failures (Sec.  900.4(a)(6)(ii)),
     include additional language requiring that facilities must
retain personnel qualification records of former employees for at least
24 months (Sec.  900.12(a)(4)),
     remove the proposed term ``digital accessory components''
and clarify the premarket requirements for devices used in mammography
(Sec.  900.12(b)(2)(i)),
     include additional language clarifying that the required
final assessment statements are only the words or phrases in quotation
marks (Sec.  900.12(c)(1)(iv)),
     revise the requirement that clinical findings or symptoms
in a patient whose mammogram assessment is negative or benign shall be
``documented and addressed,'' rather than ``explained'' (Sec.
900.12(c)(1)(iv)(A) and (B)),
     correct the reference to the two categories of breast
density that shall be included in the lay summary provided to the
patient (Sec.  900.12(c)(2)),
     include additional language clarifying the deadline for
sending the mammography report to a self-referred patient when the
assessment is ``Suspicious'' or ``Highly Suggestive of Malignancy''
(Sec.  900.12(c)(2)(i)),
     include additional language clarifying the situations in
which a facility must maintain a system for referring self-referred
patients to a healthcare provider (Sec.  900.12(c)(2)(ii)),
     revise the breast density notification language that must
be included in lay summaries provided to patients with non-dense and
dense tissue, respectively (Sec.  900.12(c)(2)(iii) and (iv)),

     add language clarifying the length of time a facility is
required to maintain the original mammograms and mammography reports in
a permanent medical record of the patient by clarifying it is for the
longer of the applicable Federal timeframes, or the mandated State or
local timeframes (Sec.  900.12(c)(4)(i)),
     add language clarifying that a facility that ceases to
perform mammography but continues to operate as a medical entity may
retain, rather than transfer, its mammography records (Sec.
900.12(c)(4)(v)),
     add or substitute the term ``patient'' in place of
references to ``women'' or ``woman'' (Sec. Sec.  900.12(c)(4)(v) and
(f)(1)),
     add the word ``audit'' to clarify that the use of certain
terms applies to the medical outcomes audit (Sec.  900.12(f)(1)), and
     include an amendment changing the name of Healthcare
Financing Administration to Centers for Medicare & Medicaid Services
and updating the Center for Devices and Radiological Health (CDRH)
office's name (Sec.  900.15(d)(1)).

IV. Legal Authority

    The MQSA (Pub. L. 102-539) was enacted on October 27, 1992, and is
codified under section 354 of the Public Health Service (PHS) Act (42
U.S.C. 263b). Under the MQSA, all mammography facilities, except
facilities of the VA, must be accredited by an approved AB and
certified by FDA (or an approved State certification agency) to provide
mammography services (42 U.S.C. 263b(b)(1) and (d)(1)(iv)). FDA is
making these amendments to the mammography regulations (set forth in
part 900 (21 CFR part 900)) under section 354 of the PHS Act, and
sections of the FD&C Act (sections 519, 537, and 704(e); 21 U.S.C.
360i, 360nn, and 374(e)).

V. Comments on the Proposed Rule and FDA's Responses

    We received several sets of comments on the proposed rule by the
close of the comment period, each containing one or more comments on
one or more issues. We received comments from medical device
associations, industry, medical and healthcare professional
associations, public health advocacy groups, law firms, and
individuals. We describe and respond to comments in sections A through
Z of this document. We have numbered each comment to help distinguish
between different comments. We have grouped similar comments together
under the same number so that FDA's responses could be addressed by
topic, instead of each comment addressed independently, and, in some
cases, we have separated different issues discussed in the same comment
and designated them as distinct comments for purposes of our responses.
The number assigned to each comment or comment topic is purely for
organizational purposes and does not signify the comment's value or
importance or the order in which comments were received or considered.

A. General Comments on the Proposed Rule

    (Comment 1) FDA received many comments that express support for the
MQSA proposed rule. Some comments express support for requiring density
notification to patients and for establishing a national standard for
such notification. Other comments respectively express support for the
changes to the assessment categories, equipment quality control (QC),
and requirements related to the provision of copies of mammograms. Some
comments express support for the changes to the patient and provider
notification in the event of compromised mammographic quality, which
may represent a serious risk to human health, including the
notification of nonphysician referring healthcare providers. Another
comment compliments FDA on proposing amendments to the regulations, but
recommends more frequent changes to respond promptly to new
information.
    (Response 1) FDA appreciates the public support for the rule. FDA
notes that the notification requirement regarding breast tissue density
will enhance communication between patients, interpreting physicians
(IP), and referring providers about this important factor in the
effectiveness of mammography, and ensure that required baseline
information is consistent. FDA also concludes that the other amendments
to the regulations (part 900), including the changes to the equipment
QC, assessment categories, provision of copies of mammograms, and
notification to nonphysician healthcare providers when necessary, will
also contribute to improvement in the quality of mammography and of
communication about mammography between patients, IPs, and providers.
Regarding the recommendation for more frequent changes, FDA notes that
it continues to engage with the National Mammography Quality Assurance
Advisory Committee (NMQAAC) and the professional and patient
mammography communities regarding the need for changes to the
regulations, but the frequency of amendments to the regulations is
based on public health need and Agency resources.
    (Comment 2) Several comments express opposition to the proposed
rule, including the following concerns: (1) that patients will not
understand that dense tissue is a normal variant, and that the proposed
breast density notification will increase their anxiety; (2) that
breast cancer information to be given to a patient should be determined
only by the patient's healthcare provider, or that the new requirement
places a burden on the healthcare provider; (3) that all medical tests
should be interpreted by clinicians with years of training who can
identify the findings that require intervention; (4) that ultrasound
rather than digital breast tomosynthesis (DBT) is the method to screen
for cancers that are not mammographically visible; and (5) that there
is no clinical recommendation to change patient management based on
density or to perform additional ultrasound and magnetic resonance
imaging (MRI) for screening dense breasts, and that current evidence
contradicts the suggestion that supplemental screening based on breast
density reduces breast cancer mortality. The latter comment also
recommends that FDA's suggestion that additional imaging based on
density alone may reduce breast cancer mortality should be deleted from
the cost and benefit information of the rule.
    (Response 2) FDA acknowledges the comments and responds according
to the numbered topics identified in Comment 2:
    (1-2) We note that breast tissue density is an important factor in
mammography, both because of the masking effect of dense tissue, which
limits the sensitivity of mammography (Refs. 9 to 11), and because
density is an independent risk factor for the development of breast
cancer (Refs. 12 to 15). FDA concludes that patients benefit from
having information about their breast anatomy, and should be informed
of their density so that the patient and their healthcare provider can
make informed and shared decisions about the patient's healthcare. This
rulemaking provides consistent language for communicating that
information, as FDA concludes that there is also a benefit from
obtaining baseline information in a consistent manner.
    The requirement to notify patients about their density is a
baseline standard and does not constrain a healthcare provider from
further discussing density with the patient. FDA has determined that
the benefit of informing patients of their density

outweighs both the burden on healthcare providers to provide density
information and the risk of patient anxiety. FDA also notes that the
Agency received many comments in support of the proposed rule and the
breast density notification to patients. FDA also notes that 38 States
have passed laws mandating notification of breast density, which may
mitigate any potential burden on healthcare providers in those states
(Ref. 8).
    (3) The MQSA provides authority to FDA to ensure quality
mammography, and FDA has determined that the initial and continuing
qualification requirements for IPs in Sec.  900.12(a)(1) are sufficient
to ensure that mammograms, including density observations, are
interpreted by personnel with adequate training to ensure quality
mammography.
    (4-5) FDA acknowledges there are conflicting comments about the
utility of other imaging modalities besides DBT, such as ultrasound,
for supplemental screening of women with dense breasts; however, this
final rule does not specify any particular supplemental imaging
modality or other particular clinical management of patients with dense
breasts. FDA has not indicated any particular additional steps in a
patient's care based only on the mammogram, as individual situations
and risk factors vary. FDA does not agree that it is appropriate to
require the lay summary to include a discussion of all possible breast
imaging modalities that may be more effective for some patients than
mammography, which would encompass a significant amount of information
that may be overwhelming and difficult for patients to interpret (see
also Responses 57 and 60). We believe that it is more appropriate for
the healthcare provider to discuss this information with the patient
and engage in shared clinical decision-making based on the patient's
individual circumstances. In this final rule, to allow patients and
their healthcare providers to make shared decisions appropriate for
each patient, the notification to these patients in Sec.
900.12(c)(2)(iv) simply states, in part, ``In some people with dense
tissue, other imaging tests in addition to a mammogram may help find
cancers,'' and advises the patient to discuss their individual
situation with their provider (see also Response 62). FDA notes that
there is conflicting evidence about the effect of supplemental
screening on breast cancer mortality, including Chiu in 2010 (Ref. 16),
which found that dense tissue was associated with increased mortality
from breast cancer. Therefore, FDA disagrees with the assertion that
additional imaging based on breast density is not relevant, or that the
mortality information should be deleted from the economic cost and
benefit analysis of the rule.
    (Comment 3) A comment opposes more mammography regulation, and
asserts:* that MQSA duplicates an American College of Radiology (ACR)
program which ``certifies'' mammography facilities; that FDA dictating
what IPs should say in their reports constitutes the practice of
medicine; and that MQSA regulations are driving physicians out of
mammography and limiting access. This comment recommends that FDA limit
itself to its ``original mandate'' to ensure that mammography units
produce quality images at a reasonable radiation dose.
    (Response 3) FDA disagrees with the comment. The ACR does not
certify mammography facilities. The MQSA and its implementing
regulations distinguish between accreditation and certification (see 42
U.S.C. 263b(e) and (q); part 900, subparts A and C; see also Response
145). The ACR is one of several FDA-approved accreditation bodies.
Accreditation, which mainly focuses on the quality of clinical images
and phantom images, is one of the prerequisites for facility
certification by FDA or a State certifying agency. FDA does not specify
which assessment category an IP should assign to a mammogram because
this is more appropriately left to the provider's interpretation in the
course of clinical decision-making. However, FDA does provide for the
specific phrasing of the final assessment statements, which is
standardized in accordance with the MQSA (42 U.S.C. 263b(a)(3)(B)) to
ensure clear consistent communication between patients, IPs, and
referring healthcare providers. FDA does not track practice rates of
IPs or other facility personnel, but is not aware of information
showing a decrease in access to mammography services; according to MQSA
national statistics (Ref. 17), from November 2003 to February 2022,
there has been a 4 percent decrease in the total number of certified
facilities across the United States but a 29 percent increase in the
total number of mammograms performed. Therefore, FDA concludes that
these amendments to the MQSA regulations are neither duplicative of the
ACR program nor have the existing MQSA regulations had a negative
impact on access to mammography.

B. Scope of the MQSA Regulations

    (Comment 4) Several comments address the scope of the MQSA
regulations, including comments that support the objectives of the
proposed rule and/or provide the following recommendations: (1) FDA's
proposal should remove xeromammography from the examples of
mammographic modalities, which accompany the definition provided in
proposed Sec.  900.2(z), and replace it with full-field digital
mammography (FFDM); (2) FDA should remove screen-film mammography from
these examples of modalities; (3) comments that FDA should also add the
example of DBT as a modality; (4) that mammography IPs should also be
qualified in breast ultrasound; and (5) that FDA should consider
requiring mammography facilities to meet additional quality standards,
such as the ACR's Breast Imaging Centers of Excellence (BICOE) program
or the American Cancer Society (ACS) National Accreditation Program for
Breast Centers (NAPBC), in addition to MQSA certification requirements.
    (Response 4) The scope of FDA's authority over mammography
facilities is established in the MQSA, and, as described in the
following and organized according to the numbered topics identified in
Comment 4, FDA is adopting limited changes to this rule:
    (1-3) The MQSA and its implementing regulations apply only to
radiological equipment used in facilities to perform mammographic
modalities, which do not include breast sonography or other non-
mammographic modalities (42 U.S.C. 263b(a)(5) and (6), (b)(1) and (2)).
However, FDA agrees that the modality of DBT has reached wide clinical
use and should be listed as an example of a mammographic modality in
this rule. Xeromammography is no longer in clinical use in the United
States, and screen-film mammography is in limited use. Therefore, in
this final rule, FDA is revising the examples of mammographic
modalities to remove xeromammography, and to list screen-film
mammography, FFDM, and DBT, all of which are currently in clinical use
in the United States (see Sec.  900.2(z) in this final rule). Other
modalities are covered by the requirements of the FD&C Act, and may be
subject to performance standards prescribed pursuant to section 534
(Electronic Product Radiation Control (EPRC)) of the FD&C Act.
    (4) FDA disagrees with the recommendation to require mammography
IPs to also be qualified in breast ultrasound. As noted, the MQSA does
not provide for the establishment of requirements related to breast
sonography for IPs, other personnel, or facilities.

    (5) FDA notes that the ACR BICOE program covers other breast
imaging modalities and interventions in addition to mammography, and
the ACS NAPBC covers additional breast imaging as well as other aspects
of clinical breast care. Therefore, these programs are not implemented
within the scope of the MQSA regulations.
    (Comment 5) Several comments recommend removing the exclusion of
invasive interventions for biopsy or localization in Sec.  900.2(aa)(1)
so that they are included within the scope of the MQSA regulations. A
separate comment recommends that post-procedure mammograms for marker
placement should not be regulated under the MQSA.
    (Response 5) FDA disagrees with these comments. The MQSA was
enacted by Congress in 1992 due to evidence of poor quality in
mammographic imaging in the United States at that time. However, since
then, the implementation of the MQSA and the widespread adoption of
digital imaging technologies and other technological and QC advances
have contributed to quality improvement not only in screening and
diagnostic mammography, but also in interventional mammography. The
majority of personnel performing interventional mammography also
perform non-interventional mammography and are therefore subject to the
requirements of the MQSA. Currently, FDA is not aware of information
showing significant quality problems with interventional mammography in
the United States. At this time, FDA concludes that it is not necessary
to introduce regulations covering interventional mammography.
    Unlike the targeted images of a small portion of the breast that
are typically performed during localization or intervention, a post-
procedure mammogram typically includes the entire breast; may be
performed using general mammography equipment rather than dedicated
interventional equipment; and is often logged, reported, and charged as
an independent examination, separate from the interventional procedure
that precedes it. Therefore, FDA concludes that this post-procedure
examination should continue to meet the quality standards mandated
under the MQSA regulations. As discussed in Responses 32, 38, and 39,
this final rule includes the assessment statement ``Post-Procedure
Mammogram for Marker Placement,'' which may be appropriate for such
mammograms (see Sec.  900.12(c)(1)(iv)(G)).
    (Comment 6) Several comments suggest that the MQSA regulations
should be expanded to cover other imaging modalities in addition to
mammography, including ultrasound and MRI.
    (Response 6) The MQSA was passed by Congress in 1992 in response to
evidence of poor quality in mammographic imaging in the United States
at that time (42 U.S.C. 263b). As we noted in Response 4, the MQSA
applies only to mammographic imaging. As such, the MQSA does not
provide for the establishment of requirements related to breast
sonography or MRI, and the MQSA regulations have not been amended to
include such modalities.
    (Comment 7) A comment recommends that medical offices be required
to display posters depicting breast anatomy and to distribute
literature regarding breast physical examination.
    (Response 7) FDA disagrees with the comment. FDA notes that the
shared clinical decision-making process generally takes place between
the patient and their referring healthcare provider or other clinical
healthcare provider, not with the interpreting physician at the
mammography facility, and therefore does not agree that there is a need
to require posters of breast anatomy at mammography facilities,
although facilities may choose to display patient education resources.
Referring healthcare providers who order mammography studies, and are
not themselves the reviewing physicians of the clinical images at issue
(see 42 U.S.C. 263b(a)(8)), are not generally subject to the
requirements specified in the MQSA and its implementing regulations.
Clinical healthcare providers may provide such patient education
resources if they choose to do so, but this recommendation is outside
the scope of this final rulemaking.

C. Repeated Failure To Achieve Accreditation

    (Comment 8) Several comments express concerns with the number and
type of accreditation failures after which an AB may not accept a
facility's application for accreditation for 1 year. One comment
recommends that this provision be revised to apply to a facility that
has ``failed to become accredited after four consecutive failures'';
another comment recommends that this be revised to apply to a facility
which has ``failed to become accredited after four failed accreditation
cycles''; and another comment recommends that this be revised to apply
to a facility that has had ``three consecutive failures of
accreditation granting cycles.'' Two of these comments also express
concern over the effect of this provision on the timing of the AB's
onsite visit to the facility to provide oversight and hands-on
training.
    (Response 8) FDA disagrees with these comments. The Agency believes
that a facility that has failed to become accredited after three
consecutive attempts should not be permitted to become accredited until
it has implemented all necessary corrective actions and any other
necessary changes, such as additional training or personnel changes,
specific to the facility's individual situation (see Sec.
900.4(a)(6)(ii) in this final rule). The Agency believes that the 1-
year waiting period will allow the facility sufficient time to make
these corrections. Regarding the terminology used for these failures,
the Agency notes that the various FDA-approved ABs currently use
different terms, such as ``deficiency'' and ``failure,'' for the
initial failure to become accredited. Therefore, FDA concludes that the
phrasing of the provision, ``If a facility has failed to become
accredited after three consecutive attempts,'' is sufficiently clear
and broad to apply to facilities accredited by any AB. Regarding the AB
onsite visits to facilities, the various ABs currently have different
policies for the timing of their onsite visits, each respectively
approved by FDA. FDA notes that, upon publication of this final rule,
the ABs can review and, if needed, revise their procedures to
accommodate the change in the regulations, including to account for any
procedures to address tracking the number of facility applications
submitted to an AB, and submit their proposed policy changes to FDA for
review and approval.
    (Comment 9) Some comments recommend that facilities not be allowed
to switch ABs in order to avoid this 1-year exclusion after three
consecutive failed attempts at accreditation.
    (Response 9) FDA agrees with this recommendation. Accordingly, we
are revising Sec.  900.4(a)(6)(ii) to state ``If a facility has failed
to become accredited after three consecutive attempts, no AB shall
accept an application for accreditation from the facility for a period
of 1 year from the date of the most recent accreditation failure.''
    (Comment 10) Some comments address the situation of a facility with
more than one mammography unit, of which one unit fails to receive
accreditation but one or more units receive accreditation. These
comments recommend either that the facility be

permitted to continue to perform mammography with the remaining
accredited unit(s), or that the facility's individual situation be
evaluated by the AB to determine the appropriate course of action.
    (Response 10) We appreciate the comment, but note that the
commenter misunderstood the proposed amendment. The provision that was
proposed for revision refers to overall facility accreditation (see
Sec.  900.4(a)(6)(ii) in both the proposed and final rule) as opposed
to individual unit accreditation (see Sec. Sec.  900.4(e) and
900.12(e)). FDA acknowledges that some reasons for the failure of a
facility to receive accreditation, such as a mechanical deficiency in a
mammography unit, may be limited to that particular unit, while other
reasons for failure, such as poor patient positioning, may extend to
the practice of mammography throughout the entire facility. The various
FDA-approved ABs have policies to address the requirements for
accreditation of a facility that has multiple mammography units. The
ABs also have policies regarding the circumstances, including poor
quality noted on accreditation images, which may prompt an AMR to
assess the overall quality of mammography at a facility. FDA believes
that if a facility fails three consecutive attempts to receive
accreditation, it should be subject to a 1-year waiting period to allow
the facility adequate time to address issues that have prevented
accreditation (see also Response 8). FDA anticipates that the ABs may
review their policies and procedures, and if needed, may decide to
submit revised policies and procedures to FDA (see Sec.  900.4(a)(8))
to conform to this provision of the final rule; if the ABs do so, the
Agency will review and consider the ABs' proposals.
    (Comment 11) A comment recommends that a facility under its third
provisional certificate have all exams double-read by a qualified IP
from an accredited and certified facility, until the applying facility
either fails or receives accreditation.
    (Response 11) FDA disagrees with adding this requirement to the
regulations. Such increased oversight of facilities with provisional
certificates is not appropriate in this circumstance, considering that
there are existing regulations requiring corrective action. Depending
on the specific circumstances of the failure, the applying facility's
AB will either have required the facility to perform corrective action
after the first two failures, or will first have performed an AMR to
determine the extent and severity of the quality problems at the
facility (see Sec.  900.4(a)(1)(i)), and will have required corrective
action (see Sec. Sec.  900.4(a)(1)(ii) and 900.4(b)(3)). Corrective
action is individualized by the AB for the specific facility, but often
includes requirements for additional training for the facility
personnel. Therefore, FDA concludes that the IP and other personnel
will be sufficiently trained to correct the quality problems at the
facility.
    (Comment 12) A comment recommends clearer language about the
facility's next steps, corrective action, ``necessary information,''
and the duration of effectiveness of a provisional certificate for a
facility that has had a year-long waiting period after having failed to
become accredited after three consecutive attempts. The same comment
recommends clearer language about FDA's action if a facility fails
accreditation for a third time, and also recommends that a facility be
permanently ineligible to provide mammography services after a fourth
failure.
    (Response 12) Regarding improving clarity about the process for
reapplying for accreditation, FDA disagrees with this comment. The
process is subject to the policies and procedures of each AB, and the
Agency notes that the necessary information as well as the steps to
apply for accreditation are clearly specified by each AB's policies and
procedures (see, e.g., Sec.  900.4(e) and (f)). We further note that
the duration of effectiveness of a provisional certificate is already
discussed in current Sec.  900.11(b) and (c). Regarding the commenter's
recommendation that a facility be ineligible to provide mammography
services after a fourth failure, FDA concludes that a facility that has
performed all required corrective action may reapply for accreditation,
but notes that, in accordance with AB policies, an AB may take into
account the facility's entire history and practice of mammography, such
as a lack of improvement after multiple corrective actions, in
considering a decision to suspend or revoke the facility's
accreditation, or to revoke its application for accreditation (see
Sec.  900.4(a) and (b)). Also, the AB must notify FDA if it believes
that a facility's practice of mammography may pose a serious risk to
human health (see Sec.  900.4(a)(2)). Likewise, the Agency may take
into account the facility's entire history in determining that its
practice poses a serious risk to human health and in considering the
suspension or revocation of a facility's certificate (see Sec.
900.14). Therefore, FDA concludes that a facility whose practice
warrants such a determination will be identified, and appropriate
accreditation and/or certificate actions will be taken. Finally, as
noted in Responses 8 and 10, if the ABs review their policies and
procedures in light of this provision of the final rule and decide to
submit revised policies and procedures to FDA (see Sec.  900.4(a)(8)),
the Agency will review and consider those policies and procedures.

D. Retention and Release of Personnel Records

    (Comment 13) Several comments were submitted that recommend
specifying the amount of time that a facility must retain personnel
records for employees that are no longer at that facility. Some
comments recommend that facilities only be required to keep the records
for former employees from the time of one inspection to the time of the
next annual inspection. Another comment recommends that facilities only
be required to give employees their records at the time of the
employees' departure. Other comments recommend that facilities be
required to keep personnel records for former employees for 24 months
following the departure of that employee.
    (Response 13) FDA agrees that a minimum length of time should be
included in the amendments to the regulations for the personnel records
retention requirement. We note that previous employees may need access
to these personnel records to document their MQSA qualifications to
permit them to provide mammography services at other facilities.
Accordingly, we conclude that former employees should have an
opportunity to obtain their personnel records for a time period beyond
the immediate date of their departure from a facility. After
considering the comments on this requirement, we are revising and
finalizing the provision as follows: ``Records of personnel no longer
employed by the facility must be maintained for no less than 24 months
from the date of the departure of an employee, and these records must
be available for review at the time of any annual inspection occurring
during those 24 months'' (see Sec.  900.12(a)(4) in this final rule).
FDA has made this change to the codified language to clarify that the
records must be available during an inspection that can occur at any
point during the 24 months after which an employee departs, which
better aligns with the records retention requirement and is distinct
from any FDA determination regarding compliance with the MQSA and its
implementing regulations that would

otherwise occur following the next annual inspection after the employee
departs. FDA is also revising the provision to distinguish and clarify
the requirements for providing such records to current and former
employees, as follows: ``The facility shall provide copies of these
personnel records to current interpreting physicians (IPs), radiologic
technologists, and medical physicists upon their request. Facilities
must provide personnel records to former employees if the former
employees communicate their request within 24 months of the date of
their departure. If it has been greater than 24 months and the facility
has maintained those records, the facility must provide those records
to former employees upon request.''
    (Comment 14) Rather than providing records after an employee
leaves, a comment recommends that facilities should require a
qualifications package for each employee that would only be retained
until after the first inspection following the hiring of that employee,
at which point the package should be given to the employee to retain,
and any continuing experience or other information would be accumulated
and maintained from the time that the qualifications package is given
to the employee.
    (Response 14) FDA disagrees with this comment. Personnel
qualifications under Sec.  900.12(a) include both initial and
continuing requirements, and both components are reviewed at the time
of inspection (Ref. 18). The personnel record keeping requirements
apply to facilities, not individual personnel (see 42 U.S.C.
263b(d)(1)(A)(ii)(III), (B)(ii)(II), and (g)(1)(C), and Sec.
900.12(a)(4)). Therefore, each facility is required to document the
qualifications of its personnel. Also, FDA is concerned that the
comment's recommended changes would not be as effective as the current
system in maintaining the necessary documentation of qualification of a
facility's personnel.
    (Comment 15) A comment recommends that FDA specify a penalty for
facilities that do not adhere to the personnel records requirement.
    (Response 15) FDA agrees with this comment. A facility that does
not comply with the personnel records retention requirement (see Sec.
900.12(a)(4) in this final rule) may receive a citation at the time
that this failure is identified at inspection, in a manner similar to
other comparable violations (Ref. 18). The totality and severity of
violations identified at inspection determine the consequences for the
facility.
    (Comment 16) A comment recommends that facilities should only need
to provide personnel records to former employees if the employee
submits the request in written format.
    (Response 16) FDA disagrees with this recommendation. FDA concludes
that requiring requests from former employees for their personnel
records to be transmitted in writing may be overly burdensome to both
facilities and former employees because it may delay how quickly a
facility would receive the request, and may reduce access to
mammography by delaying how quickly those records could be provided to
facilities evaluating the qualifications of new personnel. FDA believes
that minimizing barriers to the provision of qualification records to
former employees will facilitate the hiring of these personnel at other
facilities, thus preserving patient access to mammography services.
    (Comment 17) A comment recommends that facilities give personnel
records to personnel when the facility ceases performing mammography,
and it also asks for clarification as to whether the phrase ``ceases to
perform mammography'' refers to the facility or to specific personnel.
    (Response 17) The final rule states that ``Before a facility closes
or ceases to perform mammography services, it must make arrangements
for access by current and former personnel to their MQSA records,'' and
that this may be accomplished by either ``the permanent transfer of
these records to the personnel or the transfer of the records to a
facility or other entity that will provide access to these records for
no less than 24 months from the date of facility closure or cessation
of mammography services'' (see Sec.  900.12(a)(4)). FDA believes that
these two pathways provide adequate access for personnel to their MQSA
records. The primary reason that personnel may require access to their
qualification records is that they are continuing to practice
mammography at other facilities. Therefore, the clause ``Before a
facility closes or ceases to provide mammography services'' (see Sec.
900.12(a)(4) in this final rule) refers to the closure or cessation of
mammography services of a facility and not to the cessation of specific
personnel from practicing mammography.
    (Comment 18) A comment requests that FDA provide guidance on how to
demonstrate compliance with the requirement to provide access for
personnel to their MQSA records when a facility closes or ceases
mammography services.
    (Response 18) The Agency believes that the current regulations, and
the regulations being revised at Sec.  900.12(a)(4) in this final rule,
are clear on the requirements regarding personnel records for
facilities that close or cease to provide mammography services.
Facilities that close or cease to perform mammography services should
inform their AB, which will assist them in complying with record
retention obligations and other applicable MQSA requirements. (Ref.
19.)

E. Digital Accessories

    (Comment 19) Several comments request that FDA provide additional
clarification of the definition of a digital accessory component, or
ask for clarity on whether specific equipment, such as display
monitors, are included in this category.
    (Response 19) FDA defines an ``accessory'' of a device as ``A
finished device that is intended to support, supplement, and/or augment
the performance of one or more parent devices'' (Ref. 20). Because a
device accessory is a ``device,'' we believe the broader term
``devices'' is simpler and allows for a clearer understanding of the
mammography regulations. In this final rule, we are revising Sec.
900.12(b)(2)(i) for clarity, to state that ``All devices used in
mammography must have met the applicable FDA premarket authorization
requirements for medical devices of that type and intended use.'' This
applies to devices used in the acquisition, processing, or display of
digital mammographic images. For example, a display device used in the
interpretation of digital mammographic images generally needs to have
510(k) clearance prior to being used in a mammographic facility. Not
all equipment needs clearance or approval; for example, some devices,
such as medical image storage devices, may be exempted from premarket
notification requirements. (It is important to consult the appropriate
classification regulation to determine the premarket authorization
requirements.)
    (Comment 20) Several comments recommend changing the effective date
for the digital accessory component requirements from 18 months to 24
months.
    (Response 20) FDA disagrees with the recommendation to extend the
effective date to 24 months after publication of this final rule. FDA
considers 18 months to be a reasonable amount of time for facilities to
achieve compliance with this requirement, based on both previous
experience with the 18-month effective date specified in the 1997 MQSA
final rule (62 FR 55852, October

28, 1997) and the need for timely effectiveness of this rule.
    (Comment 21) Other comments recommend that, for QC testing of
digital accessories, in addition to the use of QC procedures in the
manufacturer's manual, the proposed rule should add an option to use
the ACR QC manual.
    (Response 21) Alternative requirements for Sec.  900.12 quality
standards are addressed in Sec.  900.18. The current ``ACR Digital
Mammography Quality Control Manual for Full-Field Digital Mammography
Systems and Supplement for Digital Breast Tomosynthesis Mammography
Systems'' has been approved as applicable to any facility as
alternative standard #24 (Ref. 21; see also Sec.  900.18(f)). The use
of approved alternative standards such as the ACR QC manual as they
relate to digital accessories remains acceptable; however, since the
ACR manual may undergo future revisions, and a revision would have to
undergo FDA review to determine whether it is at least as effective in
ensuring quality mammography as the standard it proposes to replace,
the current ACR manual is not specified in the codified section of the
final rule.
    (Comment 22) A comment expresses concern that a facility using
displays that are not specific for mammography or for a use that could
include mammography would be in violation. Another comment suggests
that, if a manufacturer QC procedure exists, there is no need for FDA
premarket authorization of displays, and continues that there is no
need for FDA premarket authorization for equipment since there are
alternative standards for QC from the ACR. A comment also asserts that
the process by which FDA clears or approves displays is not
transparent.
    (Response 22) These comments tend to confuse two separate
processes: (1) the premarket approval or clearance of a medical device
as described in 21 CFR 807.81 and (2) the MQSA requirements for
mammography facilities under 42 U.S.C. 263b and the implementing
regulations under part 900. Medical devices are subject to FDA's
medical device requirements, which may include premarket authorization.
Mammography equipment must also meet MQSA regulatory requirements that
govern its use in a mammography facility.
    FDA premarket authorization of a display intended for use in
interpreting mammography images is a premarket device requirement;
however, after this final rule becomes effective, any applicable
premarket authorization requirements will also be required under the
MQSA quality standards for use of the display for interpreting
mammography images (see Sec.  900.12(b)(2)(i) in this final rule).
Therefore, FDA agrees with the comment that a facility interpreting
mammograms using a display that has not met the applicable FDA
premarket authorization requirements for use in interpreting
mammography images would generally be in violation of the MQSA quality
standards regulations.
    The QC tests for a display are another MQSA quality standard
required for use of that display for mammography interpretation (see
Sec.  900.12(e)(6)), but the existence of QC tests for a display is
generally not sufficient to satisfy all FDA premarket regulatory
requirements that may apply to the device. Likewise, the existence of a
QC program for other mammography equipment does not generally satisfy
all the premarket regulatory requirements applicable to that equipment.
Regarding the comment that states there are QC procedures available
from ACR, we also note that facilities that adopt the ACR QC manual for
the QC of their FFDM or DBT system may not limit the use of the manual
to a single piece of equipment or accessory, such as a display, while
following a different QC program (such as the manufacturer's QC manual)
for the mammography unit (Refs. 21 and 22), and we reiterate that the
existence of a QC program does not necessarily reflect that any
applicable FDA premarket authorization requirements are being met.
    Regarding the comment on the clarity of FDA premarket review
process for mammography displays, the premarket requirements for
displays that are intended to be used in interpreting mammography
images, among others, are discussed in 21 CFR 892.2050 and FDA's
guidance ``Display Devices for Diagnostic Radiology'' (Ref. 23).
    (Comment 23) A comment states that the requirement that mammograms
submitted for interpretation be ``presented in the mammographic
modality'' in which they were originally produced is unclear, and
suggests that mammograms are being read on a device not intended for
mammography. The comment also recommends including a statement to
caution facilities that they should be aware of potential compatibility
issues in their imaging/reading chain.
    (Response 23) The requirement that mammograms be presented for
interpretation in the mammographic modality in which they were
originally produced means, for example, that screen-film mammograms
must be presented for interpretation as the original hardcopy films,
and not digitized or scanned. FDA does not agree that this requirement
would reasonably be interpreted to mean that mammograms are being read
on equipment not intended for mammography. FDA notes that all equipment
used for mammography must be specifically designed for mammography (see
Sec.  900.12(b)(2) in this final rule) and that all devices used in
mammography (including displays, as discussed in Responses 19 and 22)
must have met the applicable FDA premarket authorization requirements
for medical devices of that type and intended use (see Sec.
900.12(b)(2)(i) in this final rule). FDA agrees that facilities are
responsible for ensuring that any equipment they use in the
acquisition, processing, interpretation, retention, and retrieval of
mammographic images be compatible, in order to facilitate mammography
practice and to allow compliance with the record retention, transfer,
and release provisions in Sec.  900.12(c)(4) of this final rule. The
Agency does not believe it is necessary to include a cautionary
statement in the final rule, as facilities in the course of their
practice of mammography will readily be able to determine whether their
equipment is interoperable.

F. Facility Identification Information in Mammography Report and Lay
Summary

    (Comment 24) A comment requests clarification, in the case of a
facility that is associated with a centralized entity that sends
reports and summaries, as to whether the centralized entity may be the
only name on the report or summary, whether an abbreviated name for the
actual facility is acceptable, and whether an alias (e.g., ``Doing
Business As'' or DBA) is required to appear on the report. The
commenter also requests clarification of the required timeframe for a
facility to report a name change.
    (Response 24) FDA distinguishes each mammography facility based on
its physical location (see 42 U.S.C. 263b(a)(3) and Sec.
900.12(c)(1)(ii) in this final rule). Healthcare networks that offer
mammography services at several locations are accredited and certified
as several separate facilities. The name recognized by FDA for a
facility is the name under which the facility is accredited by its AB
(see Sec.  900.11(b)). Therefore, the facility identification
information in the report to the healthcare provider (see Sec.
900.12(c)(1)(ii) in this final rule) and the lay summary sent to the
patient (see Sec.  900.12(c)(2) in this final rule) must be unique to
the actual facility where the

mammogram was performed, and must include the name under which the
facility is accredited and certified. A change to a facility's name
must be submitted to the facility's AB, and is subsequently conveyed to
FDA by the AB (see Sec.  900.11(b)); therefore, the timeframe for
reporting a name change, as well as the acceptability of an alias or
DBA, are governed by the policies of the AB.
    (Comment 25) A comment recommends that FDA specify whether the
report identification information is required for a ``consult report.''
    (Response 25) The commenter's reference to a ``consult report'' is
not clear. Typically, a mammogram will be interpreted only once, and
will have only a single report and a single lay summary. In some cases,
a mammogram that has already been interpreted and for which a report
and lay summary have been issued is subsequently presented to another
IP for a repeat interpretation or ``second opinion.'' By referencing
determinations made by an ``outside consultant,'' the commenter may
either be referring to a later IP rendering such an additional opinion
on an examination that has already been interpreted, or may be
referring to an IP who is a contractor to a facility (rather than a
facility employee) rendering the initial or sole interpretation. If the
comment refers to the reinterpretation of a previously interpreted
mammogram, the second (or subsequent) IP must also meet the existing
personnel requirements of Sec.  900.12(a)(1), and must separately
comply with the reporting requirements of Sec.  900.12(c) in this final
rule. To help distinguish them from the original interpretation, we
recommend that a second (or subsequent) report and lay summary be
identified as a second opinion or similar term. If the comment refers
to a report rendered by an IP who is a contractor or consultant to the
facility rather than a facility employee, that IP must also meet all
personnel requirements, and the report and lay summary must meet all
reporting requirements.
    (Comment 26) Several comments address the required identification
information in the lay summary. A comment asserts that most facilities
already provide facility identification in the lay summary. Another
comment recommends that the patient name and the facility information
be required in the lay summary. A separate comment recommends that the
summary include separately both the contact information of the facility
or business where a patient can request images and records, and the
actual physical location where the mammography services were provided.
Another comment recommends that FDA not specify the information that is
required ``at a minimum,'' but rather specify all required information,
including the facility telephone number, email address, and
instructions for clear communication.
    (Response 26) FDA agrees that there have been situations in which
the facility information in the lay summary was inadequate. FDA
concludes that the expanded requirements in Sec.  900.12(c)(2) of the
final rule will enhance communication between the facility, the
patient, and the referring provider, and lead to improved patient care.
Because, as noted in Response 24, FDA identifies each facility by its
unique location (see Sec.  900.12(a)(1), in both the proposed and final
rule), the location of the facility where the mammogram was performed
must be included in the lay summary. In response to the comment
recommending that a facility's parent company information be included
in the header, FDA does not agree that such additional information
should be required because FDA identifies each facility by its unique
location and not by any affiliation with a network or company. However,
a facility may choose to include additional information about a
healthcare network, affiliated site, or records storage site. In
addition, FDA agrees with the recommendation that the facility
telephone number be included with the lay summary, and notes that Sec.
900.12(c)(2) of both the proposed and final rule include this
requirement. Because in FDA's experience, some facilities do not have
email addresses, and some others communicate through patient portals,
FDA disagrees with the recommendation to require that the lay summary
include an email address or instructions for clear communication
between the patient and the facility. FDA notes that facilities may
choose to include this additional contact information.
    (Comment 27) A comment recommends that the lay summary be required
to include the name of the IP, so that patients will know who is
involved with their care, and if dissatisfied, can request a different
IP.
    (Response 27) FDA does not believe it is necessary to require the
name of the IP as part of the lay summary. A facility may choose to
include this information, but it is not required. The Agency notes that
the lay summary is prepared after the examination has been interpreted,
so adding the name of the IP to the lay summary will not intervene
early enough for the patient to request a different IP. A patient who
prefers a particular IP would have to discuss such a request with the
facility staff before the mammogram is interpreted. After
interpretation by the IP, FDA notes that the name of the IP is included
in the report to the referring provider, per Sec.  900.12(c)(1)(iii),
and the patient can request the name either from the facility or from
the referring provider.

G. Final and Incomplete Assessments and Lay Summaries

    (Comment 28) A comment recommends that FDA clarify the limits of
the required assessment language for each mammographic assessment
category, and recommends that the rule preserve the concept that the
assessment statement is required, while the explanatory language is not
required to be included in the mammography report.
    (Response 28) For each assessment category, the required assessment
statement is only the word or phrase in quotation marks (see Sec.
900.12(c)(iv) in this final rule). As in the existing regulations, each
assessment statement, identified in quotation marks, is followed by
explanatory language, which is not in quotation marks; this explanatory
language not in quotation marks is intended to provide an explanation
of the assessment category in order to promote its consistent use, but
it is not part of the assessment statement, and is not required to be
included in the report to the referring healthcare provider nor in the
lay summary to the patient. This format of an assessment statement in
quotation marks followed by explanatory language outside the quotation
marks was also used in the existing regulations, and FDA is not aware
of significant confusion caused by this format. In both the proposed
and final rule, Sec.  900.12(c)(1)(iv)(A) through (G), the explanatory
language is distinguished from the assessment statement by the closing
quotation mark at the end of the assessment. For added clarity, in this
final rule we are revising Sec.  900.12(c)(1)(iv) to add the
parenthetical clarification, ``the assessment statement is only the
word or phrase within the quotation marks.'' We are also revising Sec.
900.12(c)(1)(iv) to replace the colon with a period within the
quotation marks surrounding each assessment statement, to further
clarify the distinction between the required statement and its
explanatory language.
    (Comment 29) A comment asserts that the negative and benign
assessment categories are functionally equivalent and recommends
combining them.
    (Response 29) FDA disagrees with this comment. Although we
acknowledge

that in most instances there may be no difference in clinical
management between patients with negative mammograms and those whose
mammograms show benign findings, the Agency notes that IPs often
distinguish between these examinations and identify benign findings if
they are present; therefore, we conclude that the negative and benign
assessment categories should remain separate.
    (Comment 30) A comment stated that the new ``Benign'' phrasing
would be confusing to patients if sent to them. Another comment
recommends that the verbiage explaining the term ``Benign'' not be
required to be in the report.
    (Response 30) FDA disagrees with the comment that the ``Benign''
phrasing would be confusing to patients. We note that the explanatory
language following the word ``Benign'' in Sec.  900.12(c)(1)(iv)(B) in
this final rule is not part of the assessment statement. It is intended
only to explain the category to IPs and other facility personnel, and
is not required to be included in the report to the referring provider
nor in the lay summary to the patient; therefore, patients are unlikely
to be presented with such phrasing. We further note that even the word
``Benign'' need not be stated to the patient; a patient summary in lay
terms of either a negative or a benign report might say, for example,
``Your mammogram is normal,'' ``Your mammogram shows no sign of
cancer,'' or similar phrasing.
    (Comment 31) A comment recommends that, in the parenthetical
statement ``if the interpreting physician is aware of clinical findings
or symptoms, despite the benign assessment, these shall be explained''
(in proposed Sec.  900.12(c)(1)(iv)(B)), the word ``explained'' should
be revised to ``documented.''
    (Response 31) FDA agrees in part with the comment. The
parenthetical statement in the explanation of the benign assessment
category is intended to mirror the existing parenthetical statement in
the explanation of the negative assessment category (in Sec.
900.12(c)(1)(iv)(A)), ``if the interpreting physician is aware of
clinical findings or symptoms, despite the negative assessment, these
shall be explained.'' However, FDA agrees with the commenter that the
IP may not always be able to explain the clinical finding or symptom in
a patient with a negative or benign mammogram. Furthermore, the IP may
have clinical information from a patient history form or interview that
is not yet known to the referring healthcare provider, and is therefore
not addressed by the subsequent requirement in proposed Sec.
900.12(c)(1)(vii) that ``All clinical questions raised by the referring
healthcare provider shall be addressed in the report to the extent
possible, even if the assessment is negative or benign.'' FDA believes
that this pertinent clinical information should be documented and, if
possible, explained or otherwise addressed. Therefore, the Agency
concludes that these parenthetical statements should be retained, with
revision as suggested, for the negative assessment category (see Sec.
900.12(c)(1)(iv)(A)) and for the benign assessment category (see Sec.
900.12(c)(1)(iv)(B)). As such, FDA is revising the parenthetical
language in this final rule for the negative and benign categories,
respectively, to state that ``if the interpreting physician is aware of
clinical findings or symptoms, despite the negative assessment, these
shall be documented and addressed,'' and ``if the interpreting
physician is aware of clinical findings or symptoms, despite the benign
assessment, these shall be documented and addressed.''
    (Comment 32) A comment requests confirmation that the new
assessment categories are part of the alternative standard approved in
2003. Another comment requests confirmation that the ``FDA-approved''
equivalent wording for assessment categories is still permitted, and
asserts that IPs should have the option to report equivalent language
rather than the assessment statements in the regulations.
    (Response 32) The new assessment statement ``Post-Procedure
Mammogram for Marker Placement'' (Sec.  900.12(c)(1)(iv)(G)) is
identical to alternative standard #12 approved by FDA in 2003 (Ref.
24). The new assessment statements ``Incomplete: Need Additional
Imaging Evaluation'' (Sec.  900.12(c)(1)(v)(A)) and ``Incomplete: Need
Prior Mammograms for Comparison'' (Sec.  900.12(c)(1)(v)(B)) are
derived from alternative standard #11 approved by FDA in 2003 (Ref.
25). The statements ``Incomplete: Need Additional Imaging Evaluation''
and ``Incomplete: Need Prior Mammograms for Comparison'' represent the
division of the single assessment statement in alternative standard #11
into two new assessment statements. These statements reflect FDA's
recognition that some mammograms require comparison for interpretation,
while some mammograms require additional imaging to reach a final
interpretation.
    The only authorized assessment statements are those in the quality
standards and the approved alternative standards (Refs. 22 and 24; see
also Sec. Sec.  900.12(c)(1)(iv) and 900.18). In addition, as described
in the MQSA Policy Guidance Help System (PGHS), FDA has acknowledged
that some closely worded variations of the approved assessment
statements may generally be acceptable where the particular wording
does not change the meaning of the category (Ref. 26).
    (Comment 33) A comment expresses concern that the reporting
requirements, which seemingly would allow for an automated process of
an IP selecting prepared comments that match the assessment categories,
do not include an assessment statement or comment for patients with a
history of breast cancer surgery who are subsequently undergoing
routine screening.
    (Response 33) Although FDA places requirements on the wording of
the assessment statement used to describe the assessment category
selected by the IP to promote clarity of communication between the IP
and the referring clinical healthcare provider, we anticipate that the
mammography report may include additional information about the
findings of the examination, before the concluding assessment
statement. FDA agrees that, after an IP examines the images, the IP may
select prepared statements that in the IP's judgment accurately
describe the findings of the examination, and likewise may select the
final assessment from a prepared list of the approved assessment
statements. The Agency anticipates that there will be some mammograms
whose findings necessitate additional nonstandard statements within the
report, but the report must conclude with one of the standard approved
assessment statements listed in Sec.  900.12(c)(1)(iv)(A) through (G).
As applicable to the commenter's example, the patient's history of
cancer and prior surgery, and any relevant post-surgical findings on
the images, may be described in the report, but it must conclude with a
final assessment chosen from the approved statements; for example,
``Benign'' (see Sec.  900.12(c)(1)(iv)(B)) or ``Suspicious'' (see Sec.
900.12(c)(1)(iv)(D)). The Agency does not believe it is necessary to
add a unique assessment statement for patients with the history
described by the commenter, as the statements listed in Sec.
900.12(c)(1)(iv)(A) through (G) are adequate to encompass patients who
have previously had breast cancer and those who have had surgery,
whether for cancer or other reasons.
    (Comment 34) A comment mentions the potential limitations of a
mammogram when a patient either cannot cooperate with or cannot
understand instructions, and recommends that FDA add assessment
categories that reflect these limitations,

including ``Benign with technical limitation'' and ``Normal with
technical limitation.'' Similarly, another comment mentions the
limitation of dense breast tissue and recommends that FDA add an
assessment category for ``Normal but dense.''
    (Response 34) FDA agrees that some mammograms have technical
limitations, but concludes that the limitations should be documented
elsewhere in the report, not in the assessment statement. For clarity,
the assessment statement should represent only the IP's final
conclusion about the results of the examination. The limitation of
breast density is addressed elsewhere in this final rule (see Sec.
900.12(c)(1)(vi)(A) through (D)). In particular, the limitations
conferred by dense tissue must be stated elsewhere in the report, using
the language in Sec.  900.12(c)(1)(vi)(C) of the final rule, ``The
breasts are heterogeneously dense, which may obscure small masses,'' or
Sec.  900.12(c)(1)(vi)(D) of the final rule, ``The breasts are
extremely dense, which lowers the sensitivity of mammography.''
    (Comment 35) Several comments address the assessment category
``Suspicious,'' which the commenters erroneously refer to as a
numerical category 4. These comments recommend that the use of
alphanumeric subcategories 4a, 4b, and 4c be allowed, be encouraged, or
be considered a legitimate option.
    (Response 35) FDA disagrees with the recommendations to permit or
encourage the use of alphanumeric subcategories instead of the
assessment statement ``Suspicious.'' All the required assessment
statements under the MQSA quality standards are words or phrases, not
numbers. Thus, the assessment statements are not identical to the
numerical codes derived from ACR's Breast Imaging--Reporting and Data
System (BI-RADS) (Refs. 26 and 27). BI-RADS is a practice guideline
published by a professional society (the ACR), and is not associated
with the MQSA quality standard requirements. While a numeric or
alphanumeric BI-RADS assessment code in addition to the assessment
statement may be used, one of the overall final assessment of findings
statements as described in Sec.  900.12(c)(1)(iv) of this final rule
must appear in the report.
    For example, in BI-RADS, category 4 (Suspicious) offers optional
subcategories a through c, and phrases associated with each letter (4a:
``Low suspicion for malignancy,'' 4b: ``Moderate suspicion for
malignancy,'' and 4c: ``High suspicion for malignancy''), to further
refine the level of suspicion (Ref. 28). However, for any mammogram
that would receive an ACR BI-RADS code of either 4, 4a, 4b, or 4c, the
assessment statement required under the MQSA quality standards is not a
number or a letter, but the word ``Suspicious.'' Additionally, the
phrase associated with each ACR BI-RADS code 4a through 4c is not an
approved alternative standard for use as an assessment statement; while
the final rule does not prohibit such a statement from being included
in the report, the overall final assessment statement, ``Suspicious,''
would be the appropriate statement to include as the final assessment
category of the mammogram (Ref. 29).
    (Comment 36) A comment recommends that FDA provide examples of when
referral of a self-referred patient to a healthcare provider is
mammographically indicated.
    (Response 36) The proposed Sec.  900.12(c)(2)(ii) stated that
``Each facility that accepts patients who do not have a healthcare
provider shall maintain a system for referring such patients to a
healthcare provider when mammographically or clinically indicated.''
FDA believes that such referral is indicated when the mammographic
findings warrant followup imaging or intervention sooner than at a
routine screening interval. Therefore, for patients who do not have a
healthcare provider and whose mammogram results are either probably
benign, suspicious, or highly suggestive of malignancy, referral to a
provider is generally mammographically indicated. For clarity, FDA is
revising this provision to state, ``Each facility that accepts patients
who do not have a healthcare provider shall maintain a system for
referring such patients to a healthcare provider when clinically
indicated, which shall include when such patients' mammogram assessment
is either probably benign, suspicious, or highly suggestive of
malignancy'' (see Sec.  900.12(c)(2)(ii) in this final rule).
    (Comment 37) A comment recommends that the lay summary inform the
patient if risk factors such as density, pain, calcifications,
discharge, and other items are identified on the mammogram.
    (Response 37) FDA does not believe it is necessary to require this
information in the lay summary. The facility is required to send the
patient a summary of the mammography report written in lay terms (see
Sec.  900.12(c)(2) in this final rule). This final rule adds breast
density notification language to the lay summary requirement, but it
does not require that the lay summary mention patient symptoms or
individual mammographic findings. FDA does not believe that it is
appropriate to require specific language for the wide range of breast
symptoms and mammographic findings that may be identified. For example,
some of the items mentioned in the comment, such as pain and discharge,
cannot be identified on a mammogram. The regulations require that the
mammography report to the provider address findings, clinical questions
raised by the referring healthcare provider, and recommendations for
additional actions, if any, (see Sec. Sec.  900.12(c)(1)(iv)(A) and (B)
and (vii) in this final rule). Some findings or symptoms may be present
but not clinically significant. The referring healthcare provider, who
receives the mammography report and is also familiar with the patient's
history and physical findings, is best positioned to discuss the case
with the patient.
    (Comment 38) Several comments address the proposed final assessment
category ``Post Procedure Mammograms for Marker Placement.'' A comment
asserts that the addition of an assessment category for a post-
procedure mammogram is unnecessary. Another comment asserts that the
post-procedure mammogram is ``bundled into'' the interventional
procedure and does not receive an assessment. A comment requests
clarification on whether a mammogram documenting a biopsy clip or
marker requires documentation.
    (Response 38) The assessment statement ``Post Procedure Mammograms
for Marker Placement'' was approved as alternative standard #12 on
September 17, 2003 (Ref. 24), under the mechanism described in current
Sec.  900.18 for the approval of alternatives to the MQSA quality
standards in Sec.  900.12. Since its approval in 2003, it has been
available and acceptable for use as a final assessment statement. In
this final rule, Sec.  900.12(c)(1)(iv)(G), FDA is adding the nearly
identical assessment statement ``Post-Procedure Mammogram for Marker
Placement'' to the implementing regulations. The situations in which
this assessment should be given to any particular mammogram are more
appropriate for the IP to determine in the course of clinical decision-
making. As FDA described in approval of the alternative standard, if a
facility makes the post-procedure examination part of the
interventional procedure instead of a separately charged examination,
then the examination is not subject to the MQSA quality standard
requirement and need not receive an assessment (Ref. 24). Nor would it
require any report separate from the report of the

interventional procedure. However, when the post-procedure mammogram is
logged or charged separately from the interventional procedure, this
mammogram is a separate examination and requires a separate report.
    This ``Post-Procedure'' assessment category is useful to
distinguish examinations that simply document the localization of a
known abnormality or a known marker without contributing new diagnostic
information, so that these examinations are not misconstrued as showing
new or additional abnormalities. The availability of a post-procedure
assessment category also helps maintain the accuracy of the medical
outcomes audit required under Sec.  900.12(f). The audit requires
followup for positive mammograms, defined in existing Sec.  900.2(mm)
as mammograms receiving assessments of either ``Suspicious'' or
``Highly Suggestive of Malignancy,'' but a post-procedure mammogram of
a patient with a previously identified abnormality is not intended to
be counted as a new positive result; this assessment category helps
facilities to distinguish and exclude post-procedure mammograms from
the audit.
    (Comment 39) Two comments object to FDA's mention of a
``localization needle'' in the explanation of one potential use for
this ``Post-Procedure Mammogram for Marker Placement'' final
assessment, since spatial localization may not always be performed with
a needle, and recommends revising this explanation to ``localization
device'' or ``localization marker.'' Another comment asserts that a
marker may not always deploy and recommends changing the wording of the
assessment statement to ``Post procedure mammogram.''
    (Response 39) FDA agrees that some localization devices are not
needles, and is clarifying our explanation of the assessment category
as follows: this category is primarily used for a mammogram performed
following a biopsy to confirm the deployment and position of a breast
tissue marker. The other use of this final assessment category is for a
mammogram performed to document the position of a localization needle
or other marker. During preoperative localization, a needle or other
temporary marker may be positioned to direct subsequent surgery for a
nonpalpable lesion seen on earlier mammography. The post-procedure
mammogram is performed as a guide to identify the suspicious site for
the surgeon who will biopsy or excise the lesion and remove the needle
or marker.
    The post-procedure mammogram is typically performed in an attempt
to localize a device, such as a needle or other tissue marker, or to
determine whether the device has deployed. FDA concludes that this
intention is accurately captured by the phrasing ``Post-Procedure
Mammogram for Marker Placement,'' even in cases in which the mammogram
reveals that a marker failed to deploy. FDA notes that all mammographic
views obtained in a single examination are typically referred to
collectively as a ``mammogram,'' and therefore agrees in part with the
comment that recommends changing the wording of the assessment
statement to the singular ``Post procedure mammogram.'' Accordingly, we
are revising the wording of the assessment statement to the singular
``Post-Procedure Mammogram for Marker Placement'' (see Sec.
900.12(c)(1)(iv)(G) in this final rule), in addition to clarifying the
description as noted.
    (Comment 40) One comment asserts that a lay-language summary to the
patient should not be required for a mammogram performed for marker
placement, because the mammogram is performed for localization rather
than for diagnosis, and receiving a lay summary of such an examination
may confuse the patient.
    (Response 40) As discussed in Response 38, we have explained that
if a facility makes the post-procedure mammogram a separately logged or
charged examination rather than part of the interventional procedure,
the mammogram is subject to all MQSA quality standard requirements,
including a report to the referring healthcare provider and a summary
of the report in lay language to the patient. The lay summary must be
specific to the examination and report; for example, if the assessment
statement in a report states that an examination was a post-procedure
mammogram for marker placement, then the lay summary of that report
should likewise mention the procedure or the marker placement, but it
would not be appropriate to state that the mammogram results were
abnormal, worrisome, suspicious for cancer, etc. FDA believes that a
lay summary limited to discussing the fact that the mammogram was
performed for localization after a procedure will not confuse a patient
who has just undergone a procedure.
    (Comment 41) Several comments recommend that FDA revise the
assessment statement ``Incomplete: Need prior mammograms for
comparison'' (proposed Sec.  900.12(c)(1)(v)(B)) to replace
``mammograms'' with ``breast imaging'' or ``breast examinations,'' to
include other imaging modalities such as breast ultrasound.
    (Response 41) FDA disagrees with this recommendation. The Agency
concludes that extending the assessment statement ``Incomplete: Need
prior mammograms for comparison'' to a comparison with other breast
imaging modalities, which may have been performed at multiple different
imaging facilities and centers, could impose delays in obtaining those
prior examinations and issuing the final interpretation of the
mammogram. As addressed in Response 4, the MQSA and FDA's implementing
regulations apply specifically to mammography facilities, so facilities
where a patient's prior mammograms were performed would have retained
those examinations, pursuant to the MQSA record retention requirement
(see Sec.  900.12(c)(4)(i) in this final rule), and would presumably
respond to the patient's request to transfer them or release copies of
their records, pursuant to the MQSA record release requirements (see
Sec.  900.12(c)(4)(ii) and (iii) in this final rule). In contrast,
other imaging centers not subject to the MQSA quality standards are not
required to release prior non-mammography imaging within these
regulatory deadlines. Additionally, other imaging modalities may not
provide the type of information that is directly comparable to the
mammogram.
    (Comment 42) A comment requests confirmation that an Incomplete
assessment statement, which the commenter cites as ``Category 0:
Incomplete--need additional imaging evaluation and/or comparison with
prior examination(s),'' remains acceptable. Similarly, another comment
recommends that FDA allow facilities to choose whether to separate the
two Incomplete assessment categories or to keep them grouped together.
    (Response 42) The first commenter's citation of the assessment
statement is incorrect on two points. As we noted in Response 35, all
approved assessment statements under the MQSA quality standards are
words or phrases, not numeric or alphanumeric codes, so the numeral
zero is not required as part of the assessment. Also, the Incomplete
assessment statement approved by FDA in 2003 as alternative standard
#11 does not refer to ``prior examinations,'' but to ``prior
mammograms.'' Therefore, the phrasing cited by the first commenter is
not acceptable. However, we note that even after the introduction of
the two Incomplete assessment statements in this final rule,
alternative standard #11 remains in effect, such that the

combined assessment statement ``Incomplete: Need additional imaging
evaluation and/or prior mammograms for comparison'' may also be used.
Therefore, FDA agrees with the second commenter that a facility may
choose either to use one of the separate Incomplete assessment
statements that appear in this final rule (see Sec.  900.12(c)(1)(v)(A)
and (B)), or to use the combined statement as found in alternative
standard #11, which remains an approved alternative standard.
    (Comment 43) A comment recommends that FDA expand and clarify its
justification of the assessment category ``Incomplete: Need prior
mammograms for comparison'' with a more evidence-based justification
addressing the value of the comparison of a mammogram with prior
mammograms. The proposed rule (under section V.E.3 of the Supplemental
Materials) includes the statement, ``Comparison to previous
examinations is sometimes required to make a final assessment.''
However, the comment recommends that FDA instead justify the value of
comparison mammograms by using the statement, ``Evidence shows that
comparison with a single prior exam, and more so with multiple prior
examinations, improves accuracy, including a reduction in the recall
rate and an improvement in sensitivity and predictive value.''
    (Response 43) The reference cited by the commenter (Ref. 30)
demonstrates that comparison to two or more prior exams reduces the
recall rate, and increases the cancer detection rate and a positive
predictive value (PPV) known as PPV1. Although comparison to previous
examinations is valuable, FDA does not believe that the recommended
statement is fully supported by the cited reference. However, FDA
agrees with the commenter's broader implication that there are many
benefits to interpreting a mammogram in comparison to one or more of
the patient's previous mammograms, including but not limited to
improved accuracy and reduced recall rate. FDA believes that the final
rule adequately reflects the value of making comparisons to previous
mammograms when available.
    (Comment 44) Some comments express concern about the timing of
interpretation of a mammogram following an assessment of ``Incomplete:
Need prior mammograms for comparison.'' A comment asserts that a
patient may not be able to obtain prior mammograms within 30 days, and
another comment asserts that the rule would permit a total of 60 days
from the performance of the examination to the final interpretation,
assuming 30 days to obtain the prior examination and another 30 days to
make the comparison and issue a final report, and that during that time
the patient's insurance or healthcare provider may change. One of the
commenters recommends that FDA impose a total limit of 30 days from the
performance of the examination to the issuance of the final report, and
one recommends that FDA monitor the use and benefit of the new
assessment category.
    (Response 44) A facility is required to issue a report to the
referring healthcare provider and a summary in lay terms to the patient
no later than 30 days after the examination (Sec.  900.12(c)(3)(i)),
and to issue a followup report no later than 30 days after issuing an
initial report of ``Incomplete: Need prior mammograms for comparison,''
whether or not comparison views can be obtained (Sec.
900.12(c)(1)(v)(B) in this final rule). However, we note that these 30-
day intervals are maximums, and represent baseline standards. There is
no requirement that a facility wait a full 30 days for a patient to
submit prior images, and likewise no requirement that a facility wait a
full 30 days after receiving a prior comparison examination before
issuing a final report. A facility may establish policies regarding a
shorter interval to wait for prior examinations and a shorter interval
in which to issue a final report after receiving comparison
examinations, perhaps with exceptions for a patient's individual
situation. Therefore, FDA concludes that the reporting deadlines stated
in the regulations as proposed and finalized are adequate. FDA also
notes that although the two ``Incomplete'' assessment statements are
new to the quality standards regulations, they are derived from the
``Incomplete'' assessment statement approved in alternative standard
#11 in 2003 (Ref. 25) and in widespread use since that time. FDA is not
aware of any concerns raised about the benefit of the use of this
assessment category or concerns about the timing of the final report.
The Agency further notes that the report is required to be sent to the
healthcare provider who referred the patient for the mammogram, unless
the patient informs the facility of a new or additional provider (Sec.
900.12(c)(3)).
    (Comment 45) A comment expresses opposition to the new assessment
statement ``Incomplete: Need prior mammograms for comparison,''
asserting that this will lead to an increase in the number of
mammograms that either do not receive a final assessment within 30
days, or do not receive one at all.
    (Response 45) FDA disagrees with this comment. First, as noted in
Response 44, this assessment statement is derived from one that has
already been eligible for use since 2003 under the approved alternative
standard #11 (Ref. 25). Furthermore, in this final rule, use of the
assessment statement ``Incomplete: Need prior mammograms for
comparison'' in Sec.  900.12(c)(v)(B) also requires that ``a followup
report with an assessment category identified in paragraphs
(c)(1)(iv)(A) through (E) of this section must be issued within 30
calendar days of the initial report whether or not comparison views can
be obtained.'' Thus, the imperative to issue a final assessment for the
examination within 30 days is directly linked to the initial use of
this incomplete assessment category. As noted, since the time that
alternative standard #11 was approved in 2003, FDA has not become aware
of any concerns raised about the timing or issuance of the final
report.

H. Deadlines for Mammography Reports

    (Comment 46) A comment recommends that the report to the healthcare
provider and the lay summary to the patient should have the same
deadline of 14 days. A separate comment recommends that screening
mammograms should have a deadline for reports and lay summaries of 30
days from the date of the examination. Another comment recommends that
when prior mammograms are needed for comparison, the report should have
a deadline of 14 days and the lay summary a deadline of 21 days,
respectively, from the receipt of the prior mammogram, not from the
date of the current examination.
    (Response 46) FDA disagrees with these comments. The deadline of 30
days from the date of the examination (or from the date of the initial
Incomplete report, if applicable) is a maximum and a baseline standard.
As noted in Response 44, facilities may choose to establish policies of
shorter deadlines for releasing prior examinations and for performing
comparisons to prior examinations. FDA concludes that the deadline
stated in this final rule is adequate. Aside from the specific audit
provisions in Sec.  900.12(f), the MQSA and FDA's implementing
regulations do not distinguish between mammograms whose clinical role
is screening or diagnosis. All examinations must meet the reporting
deadlines, and the commenter's recommendation of a 30-day deadline is
generally consistent with the regulations. FDA concludes

that the deadline for the report should be linked to the date of the
examination. This is because the receipt of prior comparison
examinations may be unpredictable and inconsistent, and using the date
of receipt of prior examinations as opposed to the date of the current
examination for the reporting deadline could lead to delays in
reporting.
    (Comment 47) Several comments note an inconsistency between, on the
one hand, the 30-day deadlines for all mammography reports (Sec.
900.12(c)(3)(i)) and lay summaries (Sec.  900.12(c)(2)), and on the
other hand, the new earlier deadlines for the report of 14 days (in
proposed Sec.  900.12(c)(3)(ii)) and lay summary of 21 days (in
proposed Sec.  900.12(c)(2)) when a mammogram is interpreted as
``Suspicious'' or ``Highly Suggestive of Malignancy.''
    (Response 47) FDA agrees with the comments and acknowledges that
these proposed deadlines were inconsistent with respect to deadlines
calculated from the date of the mammographic examination. Accordingly,
in this final rule we are revising Sec.  900.12(c)(2) by deleting the
words ``but in no case later than 21 calendar days from the date of the
mammographic examination,'' and revising Sec.  900.12(c)(3)(ii) by
deleting the words ``but in no case later than 14 calendar days from
the date of the mammographic examination.'' All reports and lay
summaries, regardless of the assessment of the mammogram, must be sent
within 30 calendar days of the examination (see Sec.  900.12(c)(2) and
(3)(ii) in this final rule). However, as noted in Response 46, this 30-
day deadline is a maximum and a baseline standard. In many facilities,
the interpretation and communication of the results is typically
performed much sooner than at 30 days. Accordingly, we consider the
within-30-day timeframe of the mammographic examination to be
appropriate, except in the following circumstances: We require that,
for positive mammograms (defined as mammograms with an assessment
category of either suspicious or highly suggestive of malignancy (see
Sec.  900.2(mm)), the facility send both the report and the lay summary
within 7 calendar days of the final interpretation of the mammogram.
For these situations, the deadline for providing the lay summary is
earlier than the general 30-day deadline from the date of the
mammographic examination for all reports and lay summaries (see
Sec. Sec.  900.12(c)(2) and (c)(3)(ii) in this final rule). As
discussed in the proposed rule (84 FR 11676), FDA believes such action
by the facility is appropriate for these two final assessment
categories because they both indicate findings that warrant further
evaluation.
    We have noted an additional inconsistency, regarding the deadlines
for sending a report to a ``self-referred'' patient who has not
identified a referring healthcare provider. A self-referred patient
receives both the lay summary and the mammography report. As discussed
above (in this response), the timeframe for sending the lay summary to
any patient, including a self-referred patient, is within 30 days of
the performance of the examination, and within 7 days of interpretation
if the assessment is ``Suspicious'' or ``Highly Suggestive of
Malignancy'' (see Sec.  900.12(c)(2) in this final rule). The timeframe
for sending the report to the self-referred patient is within 30 days
of the examination (see Sec.  900.12(c)(2)(i) in this final rule), but
the proposed rule did not specify any change in that deadline when the
results are suspicious or highly suggestive of malignancy. We are now
adding the statement ``If the assessment of the mammography report is
``Suspicious'' or ``Highly Suggestive of Malignancy,'' the facility
shall send this report to the patient within 7 calendar days of the
final interpretation of the mammograms'' (see Sec.  900.12(c)(2)(i) in
this final rule). This addition makes the 30-day and 7-day deadlines
consistent for sending the mammography report to either the referring
provider (if a patient identifies a provider) or directly to a patient
who has not identified a provider.

I. Breast Density Notification--General Support for Density
Notification

    (Comment 48) FDA received comments that support the proposed
requirements to provide information regarding breast density to both
patients and their healthcare providers, with comments recommending
that FDA finalize the regulations with the two categories of breast
density in patient lay summaries and four categories in reports to
healthcare providers as proposed.
    (Response 48) FDA appreciates the public support for the density
notification requirement. FDA believes that receiving consistent
baseline information regarding breast density is important for both
patients and their healthcare providers to make informed shared
decisions, and that the respective requirements for the report and lay
summary strike an appropriate balance between providing sufficient
information to healthcare providers while maintaining a clear message
to patients. Therefore, in this final rule, FDA is requiring that the
breast density notification use two categories of breast density in the
lay summary to patients (see Sec.  900.12(c)(2)(iii) and (iv)) and four
categories in the report to healthcare providers (see Sec.
900.12(c)(1)(vi)(A) through (D)).
    (Comment 49) A comment states that the proposed rule creates a
standard that is not backed by medical evidence.
    (Response 49) FDA disagrees with this comment. The commenter is
referring to the requirement for breast density notification. Both the
proposed amendments and this final rule do not specify the further
management of patients with dense tissue, only that these patients and
their providers must be notified of their breast density. As discussed
in Response 62, the Agency is revising the notification to patients
with dense breast tissue to reflect that ``In some people with dense
tissue, other imaging tests in addition to a mammogram may help find
cancers.'' (see Sec.  900.12(c)(2)(iv) in this final rule), which is
supported by many scientific studies demonstrating increased cancer
detection in dense breasts using supplemental imaging modalities (Refs.
10, 11, 31, and 32). This increased detection facilitates earlier
treatment of mammographically occult cancers, and may reduce morbidity
from the tumor and its treatment.
    (Comment 50) Several comments recommend that the lay summary should
contain simple, clear language, and several comments recommend that the
density information should be placed at the top of the letter instead
of following the result or assessment statement.
    (Response 50) FDA agrees with the recommendation that the lay
summary should contain clear language. In this final rule, both of the
revised notification statements for the lay summary are below the
eighth grade reading level on the Flesch-Kincaid scale. We conclude
that the notification language represents a balance of
understandability and accuracy (see Sec.  900.12(c)(2)(iii) and (iv) in
this final rule). However, the Agency does not agree that it is
necessary to require that the breast density notification statement be
placed in a specific location relative to other mammogram result
information in the lay summary. We incidentally note that the lay
summary is not required to include an assessment category or statement.
Furthermore, given the range of mammogram results and recommendations
that may need to be communicated by a facility to a patient, we
conclude that it may be unduly restrictive to make this a requirement
for facilities, and that it

may potentially be confusing to patients.
    (Comment 51) A comment recommends that an explanation of medical
terms must be included in all lay summaries.
    (Response 51) FDA disagrees with the comment. We note that the
language for the lay summary in this final rule excludes medical
terminology that may not be understandable to a wide audience. We do
not believe that it is necessary to require that an additional
explanation of medical terms be included in a lay summary.
    (Comment 52) A comment recommends that the lay summary include
additional information about mammography and its limitations.
    (Response 52) FDA disagrees with requiring this information in the
lay summary. The language in this final rule for the lay summary
includes the statement that ``Dense tissue makes it harder to find
breast cancer on a mammogram,'' and FDA concludes that this statement
is adequate in addressing the limitations of mammography as they relate
to breast density. As is also stated in the breast density notification
language (see Sec.  900.12(c)(2)(iii) and (iv) in this final rule), FDA
recommends that patients speak to their healthcare provider after
receiving the lay summary, and this discussion can include more
information on mammography and its limitations.
    (Comment 53) A comment recommends that FDA work with individuals to
improve the readability and understandability of any proposed language
and describes existing breast density notification language as poor in
understandability and causing confusion and misinformation.
    (Response 53) The breast density notification language in this
final rule is the result of discussion between clinicians, patients,
and FDA. Both the notification statement to patients with non-dense
breasts (see Sec.  900.12(c)(2)(iii) in this final rule) and the
notification statement to patients with dense breasts (see Sec.
900.12(c)(2)(iv) in this final rule) are below the eighth grade reading
level on the Flesch-Kincaid scale. We believe that these statements
represent an appropriate balance between patient understandability and
accuracy of the information conveyed. FDA cannot comment on the
understandability of various State breast density notifications;
however, FDA recommends that patients speak to their healthcare
provider about any language that they do not understand.
    (Comment 54) A comment recommends that visual aids and medical
cartoons for patients with low literacy should be included, to decrease
health disparities.
    (Response 54) FDA acknowledges that patients of limited literacy
may need assistance with the interpretation of the lay summary.
However, FDA does not believe it is necessary to require this
information in the summary. The requirements for the lay summary
represent baseline standards; FDA recognizes that facilities may choose
to provide additional information or explanation they feel is needed by
their patients. The breast density notification language in this final
rule is meant to be concise and clear, and adding visual aids and
medical cartoons into the lay summary may potentially distract from the
primary message regarding a patient's breast density and resulting
recommendations. FDA notes that the interaction between a patient and
their healthcare provider presents an appropriate opportunity to
address questions that a patient may have regarding the lay summary.
The required language in this final rule (Sec.  900.12(c)(2)(iii) and
(iv)) includes such a recommendation to talk to a healthcare provider.
    (Comment 55) Several comments recommend that in addition to the
breast density notification, FDA add patient education and a clear plan
of management to the lay summary.
    (Response 55) FDA disagrees with the comment. We conclude that the
language in this final rule provides a foundation for patients to be
informed regarding their breast density when using mammography. The
intent of the lay summary being required and provided to the patient is
not to serve as an exhaustive resource regarding breast disease and its
management. The lay summary includes the recommendation for the patient
to talk to their healthcare provider, and we note that this interaction
is an appropriate opportunity for additional patient education.
Regarding the recommendation that the lay summary include a clear plan
of management, FDA notes that the lay summary is generated by the
breast imaging facility, whereas the plan of clinical management for
each individual patient will be developed by the patient and their
healthcare provider, and as such, it is not appropriate for this type
of information to be included in the lay summary.
    (Comment 56) A comment recommends replacing the phrase, ``The
breasts are almost entirely fatty,'' in Sec.  900.12(c)(1)(vi)(A), with
the phrase, ``The breast tissue is of low density,'' asserting that the
former statement has ``negative connotations'' to many patients.
    (Response 56) FDA disagrees with the comment. FDA notes that this
category, and the others in Sec.  900.12(c)(1)(vi)(A) through (D), are
already in widespread use in breast density reporting. Thus, FDA
believes it would be confusing to replace the ``almost entirely fatty''
category with the ``low density'' sentence recommended by the
commenter, as it would be unclear whether ``low density'' referred to
the breast density category in Sec.  900.12(c)(1)(vi)(A), ``The breasts
are almost entirely fatty,'' or the density category in Sec.
900.12(c)(1)(vi)(B), ``There are scattered areas of fibroglandular
density.'' Additionally, the breast density assessment statement in
Sec.  900.12(c)(1)(vi)(A) is included only in the report intended for
the healthcare provider, and not in the lay summary sent to the
patient, so it will not be sent to patients with a referring provider.
Self-referred patients will receive the lay summary as well as the
report, which should help mitigate any unintended negative connotations
of the report.
    (Comment 57) A comment questions the benefit of the density
notification and recommends that FDA should involve more individuals in
the drafting of density notification language, and that this language
should describe the limitations of density assessment, the risks of
overdiagnosis and overtreatment such as gadolinium exposure from MRI
and radiation exposure from additional mammographic evaluation, and the
lack of benefit of density notification. A comment recommends adding
additional language educating patients about breast density, what it
means to a patient, and how patients can take extra steps to protect
themselves.
    (Response 57) FDA disagrees with the assertion of lack of benefit
in informing patients and their healthcare providers of a patient's
breast density. FDA considers it to be a benefit to inform patients
about their breast anatomy. In addition, FDA considers it to be a
benefit to inform patients in a consistent manner about their breast
density. The language in the final rule is intended as a baseline for
breast density information, which can be used by patients and their
healthcare providers to help inform and guide patient care. FDA notes
that the provider-patient interaction is an appropriate opportunity for
further discussion of breast density and of the benefits and risks of
possible further evaluation. We conclude that including too wide a
range of information in the lay summary, particularly information that

may not be supported by a wide consensus in the scientific community or
current information that may be subject to change with future advances
in knowledge and understanding, may unnecessarily increase patient
confusion and lead to reduced effectiveness of the breast density
notification.
    (Comment 58) A comment recommends eliminating the recommendation in
Sec.  900.12(c)(2)(iii) for patients with non-dense breast tissue to
talk to their healthcare provider. Another comment recommends that
patients should be directed to additional information on breast
density, not just to their referring physician.
    (Response 58) The Agency believes it is important for patients to
have an understanding of their breast density to promote informed and
shared decision making about whether supplemental screening is
appropriate based on each patient's individual circumstances, and
speaking with their healthcare provider is an additional opportunity to
accomplish this. The final rule does not prohibit facilities or
healthcare providers from providing additional information on breast
density to patients; however, FDA concludes that specific additional
resources on breast density should not be codified in the final rule as
a requirement to be provided as part of the lay summary, particularly
since these sources of information may change or become outdated.
    (Comment 59) A comment asserts that there are conflicting reports
of the density discussion at the 2011 NMQAAC meeting.
    (Response 59) FDA disagrees with the comment. A transcript of the
2011 NMQAAC meeting is available (Ref. 33). The transcript shows there
was general agreement on requiring density notification and advising