Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders: Guidance for Mammography Facilities and Food and Drug Administration Staff

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Contains Nonbinding Recommendations
Appeal Options Available to
Mammography Facilities Concerning
Adverse Accreditation Decisions,
Suspension/Revocation of Certificates, or
Patient and Referring Provider
Notification Orders
______________________________________________________________________________
Guidance for Mammography Facilities
and Food and Drug Administration
Staff
Document issued on September 10, 2024.
Document originally issued on March 2, 2022.
For questions about this document, contact the CDRH Ombudsman’s Office at 301-796-5699 or
CDRHOmbudsman@FDA.HHS.GOV.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health

Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852-
1740. Identify all comments with the docket number FDA-2020-D-1317. Comments may not be
acted upon by the Agency until the document is next revised or updated.
Additional Copies
Additional copies are available from the Internet. You may also send an email request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number
GUI00019004 and complete title of the guidance in the request.

Contains Nonbinding Recommendations
Table of Contents
I. 	Introduction ............................................................................................................................. 1
II. 	Background ............................................................................................................................. 2
III. 	Appealing an Adverse Accreditation Decision with the Accreditation Body ........................ 2
IV. 	Request for Reconsideration of Adverse Appeals Decision by the Accreditation Body ........ 3
V. 	Request for Regulatory Hearing Before the Food and Drug Administration (21 CFR Part
16) 	5
VI. 	Appealing a Patient and Referring Provider Notification (PPN) Order ................................. 6
VII. Additional Information ........................................................................................................... 7

Contains Nonbinding Recommendations
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Appeal Options Available to
Mammography Facilities Concerning
Adverse Accreditation Decisions,
Suspension/Revocation of Certificates,
or Patient and Referring Provider
Notification Orders
Guidance for Mammography Facilities
and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or
Agency) on this topic. It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff
or Office responsible for this guidance as listed on the title page .
I. 	Introduction
This guidance document describes the processes available to mammography facilities to request
additional review of an adverse appeals decision on a facility’s accreditation, and/or a suspension
or revocation of certificate, and/or a patient and referring provider notification (PPN) order.
A mammography facility that is in disagreement with an accreditation body’s adverse
accreditation or reaccreditation decision that precludes certification or recertification is entitled
to appeal the decision directly to the accreditation body. If a satisfactory resolution cannot be
reached with the accreditation body, the facility may request reconsideration (further appeal) of
the adverse appeals decision by the Director of FDA’s Division of Mammography Quality
Standards (DMQS). A facility that is dissatisfied with FDA’s decision following

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reconsideration is entitled to a formal hearing before the Departmental Appeals Board,
Department of Health and Human Services, as well as further review of the hearing officer’s
decision.1
A mammography facility that wishes to challenge a suspension or revocation of an FDA
certificate issued under the authority of the Mammography Quality Standards Act (MQSA) may
request an informal (regulatory) hearing before the FDA as described below. The FDA has
approved certain States as State Certification Agencies – or States as Certifiers (SACs) – which
are responsible for certifying facilities within the state to perform mammography.2 In these
instances, for mammography facilities that wish to challenge the suspension or revocation of a
certificate issued by a SAC under the authority of the MQSA, FDA recommends presenting such
challenge to their respective SAC. This document provides general information about each
process, as well as guidance on how to submit related requests to DMQS.
A mammography facility that wishes to appeal a PPN order may request supervisory review
(appeal) of the order under 21 CFR 10.75. The appeal should be submitted to the next level
supervisor of the official who signed the PPN order.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in Agency guidances means that something is suggested or recommended, but
not required.
II. 	Background
The Mammography Quality Standards Act (MQSA) (42 U.S.C. § 263b) requires that, before a
mammography facility can perform mammography, it must be certified. For a facility to be
certified, it must meet certain requirements including: (i) be accredited by an FDA-approved
private nonprofit or state accreditation body; (ii) undergo periodic review of its clinical images
by its accreditation body; (iii) have an annual survey by a medical physicist; (iv) meet federally
developed quality standards for personnel qualifications, equipment, radiation dose, quality
assurance programs, and recordkeeping and reporting; and (v) undergo periodic inspection [by
FDA or its designee] to ensure it meets the federally developed quality standards.
III. 	Appealing an Adverse Accreditation Decision with the
Accreditation Body
1 See 21 CFR 900.15(d)(4) (“A facility that is dissatisfied with DMQRP's decision following reconsideration is
entitled to a formal hearing in accordance with procedures set forth in subpart D of 42 CFR part 498.”).
2 For more information on SACs, see FDA’s website at
https://www.fda.gov/radiation-emitting-products/mammography-quality-standards-act-and-program/facility-
accreditation-and-certification.

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Under the MQSA, facilities3 offering mammography services must meet certain national quality
standards and be certified by FDA or a SAC approved by the FDA following accreditation by an
accreditation body.4 A list of FDA-approved accreditation bodies can be found at the following
link Facility Accreditation and Certification | FDA.5 In accordance with 21 CFR 900.7(b), when
an accreditation body denies an accreditation or reaccreditation (i.e., revocation of accreditation)
to a facility, the accreditation body shall notify the facility in writing and explain the bases for its
decision. The notification shall also describe the appeals process available from the accreditation
body to the facility to contest the decision (21 CFR 900.4(a)(6)).6 Facilities must avail
themselves of the accreditation body’s appeals process before requesting reconsideration from
FDA (21 CFR 900.15(c)).
Following revocation of accreditation, and during the 60-day period in which the facility may
appeal the adverse accreditation decision to FDA under 21 CFR 900.15, the agency may conduct
an investigation into the reasons for revocation and determine that the facility’s certificate is no
longer in effect. A facility whose certificate is no longer in effect may not practice
mammography (21 CFR 900.13(a)). Likewise, the mammography facility is not permitted to
provide mammography services while an adverse accreditation decision is being appealed to
FDA (see 21 CFR 900.15(d)(6)). Alternatively, the agency may take whatever other action or
combination of actions that will best protect the public health, including the establishment and
implementation of a corrective plan of action that will permit the certificate to continue in effect
while the facility seeks reaccreditation (21 CFR 900.13(a)).
IV. 	Request for Reconsideration of Adverse Appeals
Decision by the Accreditation Body
A request for reconsideration by FDA of an adverse appeals decision by the accreditation body
in accordance with 21 CFR 900.15 is available to mammography facilities that have exhausted
the appeals process offered by the accreditation body and are precluded from certification or
recertification by the FDA. Any such request for reconsideration must be submitted to FDA
within 60 days of the accreditation body’s adverse appeals decision (see 21 CFR
900.15(d)(3)(i)). Under 900.13(a), FDA may determine the facility’s certificate is no longer in
effect during this 60-day time period. Facilities that were instead issued a certificate by a SAC
should follow the appeals process for requesting reconsideration offered by their certifying
agency (see 21 CFR 900.22(e)).
Request for reconsideration by facilities certified by the FDA should be directed to:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
3 See 42 U.S.C. § 263b(a)(3).
4 See 42 U.S.C. § 263b(a)(1) & (e)(1)(A).
5 Available at https://www.fda.gov/radiation-emitting-products/mammography-quality-standards-act-and-
program/facility-accreditation-and-certification.
6 See Mammography Quality Standards Act final rule, published on March 10, 2023 (88 FR 15126), which goes into
effect on September 10, 2024.

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Division of Mammography Quality Standards
Attention: Program Management Team
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Included with a reconsideration request must be the accreditation body’s original denial of
accreditation, all information submitted by the facility to the accreditation body relevant to the
appeal, a copy of the accreditation body’s adverse appeals decision, and a statement detailing the
bases for the facility’s disagreement with the accreditation body’s decision (see 21 CFR
900.15(d)(3)(ii)).
Facilities that are requesting reconsideration of the accreditation body’s interpretation of images
should provide a rationale for the basis of their dispute, including instances of gross discrepancy,
along with the images submitted to the accreditation body in a format that is readily accessible
by FDA. Facilities that have questions about whether their images may be readily accessible by
FDA should contact DMQS. If a point of contact from DMQS has not been provided in prior
correspondence with FDA, mammography facilities should contact the MQSA hotline
(https://www.fda.gov/radiation-emitting-products/mammography-quality-standards-act-and-
program/contact-mqsa-program).
Requests for reconsideration of the adverse appeals decision by an accreditation body are an
opportunity for facilities to have FDA review the adverse decision made by the accreditation
body and ensure that the accreditation body followed its FDA approved procedures and policies.
To ensure a timely review, FDA recommends that facilities submit in their request for
reconsideration, all the images reviewed by the accreditation body during its underlying
decision(s). If providing new information, facilities should provide a justification for why that
new information should be considered. Generally, FDA does not intend to consider images from
prior patient exams, Digital Breast Tomosynthesis (DBT) images, or additional reviews that were
not initially submitted to the accreditation body to be relevant to the request for reconsideration
absent justification provided by the facility that the evidence is relevant and material to the
matters at issue.
Within 60 days after receipt of a reconsideration request, the Director of DMQS intends to issue
a decision and notify the facility in writing of the decision and the facility’s options as a
consequence of the decision. A facility that is dissatisfied with the Division’s decision
following reconsideration is entitled to a formal hearing before the Departmental Appeals Board,
Department of Health and Human Services (21 CFR 900.15(d)(4); see 42 CFR part 498, subpart
D). The mammography facility is not permitted to provide mammography services while the
adverse accreditation appeals decision is being further appealed to FDA or during any time
period that FDA determines the certificate is no longer in effect (see 21 CFR 900.13(a);
900.15(d)(6)). If the facility’s certificate is no longer in effect during any proceedings under 21
CFR 900.15, following those proceedings, FDA may place the certificate back into effect or
leave the certificate no longer in effect for a period of time during which any further FDA or
facility actions, or combination of actions, are implemented.

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V. 	Request for Regulatory Hearing Before the Food and
Drug Administration (21 CFR Part 16)
A mammography facility that is unable to become certified or recertified by the FDA because it
has been denied accreditation or reaccreditation (i.e., revocation of accreditation) by an
accreditation body and wishes to appeal the accreditation body’s decision should follow the
process described in Section III of this document (and subsequently Section IV of this document
if applicable).
Under 21 CFR 900.14(a), FDA may suspend or revoke a facility’s MQSA certificate under
certain circumstances . after providing the owner or operator of the facility with notice and
opportunity for a regulatory hearing under 21 CFR part 16. In most cases, a suspension would
precede a revocation (see 21 CFR 900.14(d)). To suspend or revoke an MQSA certificate under
21 CFR 900.14(a), the Agency would send the owner or operator of the facility a notice of
opportunity for regulatory hearing and a proposal to suspend or revoke the certificate (see 21
CFR 16.22(a)). The proposal would set forth the ground(s) for suspension or revocation and
specify the amount of time within which the facility could request a hearing on the ground(s) for
the proposed suspension or revocation (see 21 CFR 16.22). Under 21 CFR 16.26(a), however, a
request for a Part 16 hearing may be denied if the request fails to justify a hearing by
demonstrating a genuine and substantial issue of fact. Only after providing opportunity for a
regulatory hearing may FDA then suspend or revoke a certificate under 21 CFR 900.14(a).
Under 21 CFR 900.14(b), FDA may immediately suspend a facility’s MQSA certificate under
certain circumstances before holding a regulatory hearing. FDA does so by issuing a notice of
suspension setting forth one or more of the grounds in 21 CFR 900.14 and a determination that:
(1) failure to comply with the required standards presents a serious risk to human health; (2) the
refusal to permit inspection makes immediate suspension necessary; and/or (3) there is reason to
believe that violative acts were intentional or otherwise rise to a level that presents a threat to the
public. The notice would provide instructions for requesting a hearing, including specifying the
amount of time within which the facility could request a hearing. The Agency must provide the
facility with an opportunity for a hearing no later than 60 days from the effective date of the
suspension (21 CFR 900.14(c)). Under 21 CFR 16.26(a), however, a request for a Part 16
hearing may be denied if the request fails to justify a hearing by demonstrating a genuine and
substantial issue of fact. Any suspension goes into immediate effect upon receipt of the notice of
suspension and remains in effect until the Agency makes a determination that the allegations of
violations or misconduct were not substantiated, violations of required standards have been
corrected to the Agency’s satisfaction, or the facility’s certificate is revoked in accordance with
21 CFR 900.14(d) (see 21 CFR 900.14(c)(2)). Following a suspension under 21 CFR 900.14(b),
FDA may revoke the facility’s certificate if a determination is made that the facility is unwilling
or unable to correct violations that were the basis for suspension, or the facility has engaged in
fraudulent activity to obtain or continue certification (21 CFR 900.14(d)).
When FDA provides a notice of opportunity for hearing under either of these suspension or
revocation methods, the notice will designate an FDA employee in the Office of the
Commissioner through whom the facility may request a Part 16 hearing. A facility may request
a hearing by mail, telegram, telex, personal delivery, or any other mode of written

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communication (see 21 CFR 16.22(b)). For mammography facilities that wish to challenge the
suspension or revocation of a certificate that was instead issued by a SAC under the authority of
the MQSA, FDA recommends presenting such challenge to their respective SAC under its FDA-
approved process (see 42 U.S.C. 263b(q)(1)(A); 21 CFR 900.21(b)(3)(iii)(C); 900.22(d)).
A notice of opportunity for hearing will not operate to delay or stay any other administrative
action (see 21 CFR 16.22(d)). The facility is not permitted to provide mammography services
during the time period when a certificate is suspended or revoked (see 21 CFR 900.11(a) and
(c)). Further, if a facility’s certificate is revoked based on an act described in 42 U.S.C.
263b(i)(1), as implemented by 21 CFR 900.14(a), no person who owned or operated that facility
at the time the act occurred may own or operate a mammography facility within 2 years of the
date of revocation (see 21 CFR 900.11(c)(4)).
VI. 	Appealing a Patient and Referring Provider
Notification (PPN) Order
Based on the results of an additional mammography review (AMR) ordered under 21 CFR
900.12(j)(1), a facility’s failure to comply with the terms of an AMR, or other information, FDA
or a SAC may determine that the quality of mammography performed by a facility, whether or
not certified under 21 CFR 900.11, was so inconsistent with the quality standards as to present a
significant risk to human health. (See 21 CFR 900.12 (j)(2)). FDA or the SAC has the authority
to require the facility to notify all patients who received mammograms at the facility or those
patients who are determined to be at risk due to the quality of their mammography, and their
referring physicians or other healthcare providers, of the deficiencies, potential harm, appropriate
remedial measures and other relevant information required by the FDA or SAC. Such an order is
referred to as a Patient and Referring Provider Notification (PPN) order, and facilities required to
issue a PPN must do so within a timeframe and in a manner specified by FDA or the SAC. If the
facility is unable or unwilling to perform such notification, FDA or the SAC may notify patients
and their referring physicians or other healthcare providers individually or through the mass
media.
Failure to comply with the MQSA or its implementing regulations, including failure to comply with a
PPN ordered by FDA under 21 CFR 900.12(j)(2), may result in penalties and/or sanctions, including:
• Revocation of certification (42 U.S.C. 263b(i));
• Civil money penalty charges, including, when a facility does not comply with a PPN
ordered by FDA under 21 CFR 900.12(j)(2), a per day charge for each day a facility fails to
meet the quality standards and additional charges for each failure to notify a patient of the
existing risk (42 U.S.C. 263b(h)(3); 45 CFR 102.3);
• Injunction proceedings by the FDA against a facility (42 U.S.C. 263b(j)).

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In accordance with 21 CFR 10.75, a facility receiving a PPN order can appeal the order to the
next level supervisor of the official who signed the PPN order.7 A request for supervisory
review (appeal) must be addressed to the next organizational level or higher above the individual
who made the decision; marked “Appeal: Request for Supervisory Review” in the subject line of
the electronic request; and sent to the CDRH Ombudsman at CDRHOmbudsman@fda.hhs.gov
(see 21 CFR 800.75(b)(2)). The request for supervisory review should be received by the FDA
within 30 days of the issuance date of the PPN order to ensure the appeal can be reviewed in a
timely manner and prior to the deadlines provided in the PPN order. Any appeal received after
60 days of the date the PPN order was issued will be denied as untimely, unless CDRH, for good
cause, permits the request to be filed after 60 days (see 21 CFR 800.75(b)(2)). A request for
supervisory review under section 10.75 does not delay or stay the actions required by the PPN
order (see 21 CFR 10.35).
FDA’s decision to require a facility to conduct a PPN is often based on findings made by the
accreditation body during the AMR review. Information a facility submits as part of a request for
supervisory review of a PPN order (in accordance with 21 CFR 10.75) that is not related to
deficiencies identified in the AMR may not be determinative in FDA’s decision on the request.
If a facility submits both an appeal of the adverse accreditation decision to FDA (under 21 CFR
900.15) and a request for supervisory review of the PPN order (in accordance with 21 CFR
10.75), then generally FDA will not issue a decision for the 10.75 appeal of the PPN order until a
decision on the 900.15 appeal has been issued to the facility.
Facilities that wish to appeal a PPN order that was instead issued by their certifying agency
should follow the appeals processes offered by their respective SAC under its FDA-approved
process (see 42 U.S.C. 263b(h)(2); 21 CFR 900.21(b)(3)(iii)(N); 900.22(g)).
VII. Additional Information
Copies of regulations discussed in this document are available from the U.S. Government
Printing Office. They may also be found and downloaded by accessing the CFR on the Internet
at www.ecfr.gov and searching CFR titles and volumes.8
You may also contact the CDRH Ombudsman’s Office at 301-796-5699 or
CDRHOmbudsman@FDA.HHS.GOV with questions regarding the policies and procedures
discussed in this document.
7 See also FDA’s guidances, “Center for Devices and Radiological Health (CDRH) Appeals Processes,” available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-radiological-health-
cdrh-appeals-processes, and “Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions
and Answers About 517A,” available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/center-devices-and-radiological-health-cdrh-appeals-processes-questions-and-answers-about-517a.
8 Available at https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR.