Contains Nonbinding Recommendations
Appeal Options Available to 
Mammography Facilities Concerning 
Adverse Accreditation Decisions, 
Suspension/Revocation of Certificates, or 
Patient and Physician Notification Orders
______________________________________________________________________________
Guidance for Mammography Facilities 
and Food and Drug Administration 
Staff
Document issued on March 2, 2022.
The draft of this document was issued on July 21, 2020.
This document supersedes section 4.5 of the Center for Devices and 
Radiological Health (CDRH) Appeals Processes guidance document issued on 
July 2, 2019. 
For questions about this document, contact the CDRH Ombudsmans 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
1 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. 
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 
190004 and complete title of the guidance in the request.
2 Contains Nonbinding Recommendations
Table of Contents
I.  Introduction ............................................................................................................................. 4
II.  Background ............................................................................................................................. 5
III.  Appealing an Adverse Accreditation Decision with the Accreditation Body ........................ 5
IV.  Request for Reconsideration of Adverse Appeals Decision by the Accreditation Body ........ 6
V.  Request for Regulatory Hearing Before the Food and Drug Administration (21 CFR Part 
16)  8
VI.  Appealing a Patient and Physician Notification (PPN) Order ................................................ 9
VII. Additional Information ......................................................................................................... 10
3 Contains Nonbinding Recommendations
Appeal Options Available to 
Mammography Facilities Concerning 
Adverse Accreditation Decisions, 
Suspension/Revocation of Certificates, 
or Patient and Physician Notification 
Orders
______________________________________________________________________________
Guidance for Mammography Facilities 
and
Food and Drug Administration Staff
This guidancerepresents 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 facilitys accreditation, and/or a suspension 
or revocation of certificate, and/or a patient and physician notification (PPN) order.  This 
guidance supersedes section 4.5 of the Center for Devices and Radiological Health (CDRH) 
Appeals Processes guidance document dated July 2, 2019.1  The remainder of the July 2, 2019 
CDRH Appeals guidance, with the exception of technical edits for consistency with the newly 
amended section 4.5, was not substantively changed.
A mammography facility that is in disagreement with an accreditation bodys 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 
1 Available on FDAs website at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/center-devices-and-radiological-health-cdrh-appeals-processes. 
4 Contains Nonbinding Recommendations
reached with the accreditation body, the facility may request reconsideration (further appeal) of 
the adverse appeals decision by the Director of FDAs Division of Mammography Quality 
Standards (DMQS).  If a facility is further dissatisfied with FDAs reconsideration decision, it 
may request a formal hearing before the Departmental Appeals Board, Department of Health and 
Human Services, as well as further review of the hearing officers decision.  
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. 
The  contents of this document do not have the force and effect of law and are not meant to bind 
the public in any way, unless specifically incorporated into a contract. This document is intended 
only to provide clarity to the public regarding existing requirements under the law. FDA 
guidance documents, including this guidance, should be viewed only as recommendations, unless 
specific regulatory or statutory requirements are cited.  The use of the word should in Agency 
guidance 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: be accredited by an FDA-approved private 
nonprofit or state accreditation body; undergo periodic review of its clinical images by its 
accreditation body; have an annual survey by a medical physicist; meet federally developed 
quality standards for personnel qualifications, equipment, radiation dose, quality assurance 
programs, and recordkeeping and reporting; and 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
2 For more information on SACs, see FDAs website at https://www.fda.gov/radiation-emitting-
products/mqsa-insights/states-certifiers-who-they-are-and-what-they-do 
5 Contains Nonbinding Recommendations
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 MQSA: Accreditation Bodies.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)).  Facilities must avail themselves of the 
accreditation bodys 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 facilitys 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 bodys adverse appeals decision (see 21 CFR 
900.15(d)(3)(i)).  Under 900.13(a), FDA may determine the facilitys 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 
Division of Mammography Quality Standards 
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/facility-certification-and-
inspection-mqsa/mqsa-accreditation-bodies 
6 Contains Nonbinding Recommendations
Attention: Program Management Branch 
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Included with a reconsideration request must be the accreditation bodys original denial of 
accreditation, all information submitted by the facility to the accreditation body relevant to the 
appeal, a copy of the accreditation bodys adverse appeals decision, and a statement detailing the 
bases for the facilitys disagreement with the accreditation bodys decision (see 21 CFR 
900.15(d)(3)(ii)).  
Facilities that are requesting reconsideration of the accreditation bodys 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 
correspondance 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 facilitys options as a 
consequence of the decision.  A facility that is dissatisfied with the Divisions 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 facilitys 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. 
7 Contains Nonbinding Recommendations
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 bodys 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 facilitys 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 21 CFR 900.14(a).
Under 21 CFR 900.14(b), FDA may immediately suspend a facilitys 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 Agencys satisfaction, or the facilitys 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 facilitys 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 
8 Contains Nonbinding Recommendations
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)). 
VI.  Appealing a Patient and Physician Notification (PPN) 
Order 
In accordance with 21 CFR 900.12(j)(2), if FDA or a SAC determines the quality of 
mammography performed by a facility, whether or not certified under 21 CFR 900.11, is so 
inconsistent with the quality standards as to present a significant risk to individual or public 
health, the certifying agency has the authority to require the facility to notify patients who 
received mammograms and their referring physicians of the deficiencies, potential harm, 
appropriate remedial measures and other relevant information required by the FDA.  In 
accordance with 21 CFR 10.75, a facility receiving such a Patient and Physician Notification 
(PPN) order can appeal the order to the next level supervisor of the official who signed the PPN 
order.6  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). 
FDAs decision to require a facility to conduct a PPN is often based on findings made by the 
accreditation body during the AMR review. 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
6 See also FDAs 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. 
9 Contains Nonbinding Recommendations
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.7
You may also contact the CDRH Ombudsmans Office at 301-796-5699 or 
CDRHOmbudsman@FDA.HHS.GOV with questions regarding the policies and procedures 
discussed in this document. 
7 Available at https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR 
10