Guidance for Industry, MQSA 
Inspectors and FDA Staff  
 
The Mammography Quality 
Standards Act Final Regulations: 
Modifications and Additions to 
Policy Guidance Help System #13  
     Document issued on: November 16, 2010 
The draft of this document was issued on October 9, 2009. 
 
 
 
 
For questions regarding this document contact Charles Finder at 301-796-5710 or by email 
at charles.finder@fda.hhs.gov.   
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Division of Mammography Quality and Radiation Programs 
Office of Communication, Education, and Radiation Programs  Preface 
Public Comment 
Written comments and suggestions may be submitted at any time for Agency consideration 
to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers 
Lane, Room 1061, (HFA-305), Rockville, MD, 20852.  Alternatively, electronic comments 
may be submitted to http://www.regulations.gov.  When submitting comments, please refer 
to Docket No. FDA-2009-D-0448.  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 at: 
http://www.fda.gov/Radiation-
EmittingProducts/MammographyQualityStandardsActandProgram/default.htm.  
You may also send an e-mail request to dsmica@fda.hhs.gov to receive an 
electronic copy of the guidance or send a fax request to 301-847-8149 to receive a 
hard copy.  Please use the document number 1695 to identify the guidance you are 
requesting.  
  2   Guidance for Industry, MQSA 
Inspectors, and FDA Staff 
 
 
The Mammography Quality Standards 
Act Final Regulations: Modifications and 
Additions to Policy Guidance Help 
System #13   
This guidance represents the Food and Drug Administration's (FDA's) current 
thinking on this topic.  It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public.  You can use an alternative approach if the 
approach satisfies the requirements of the applicable statutes and regulations.  If you 
want to discuss an alternative approach, contact the FDA staff responsible for 
implementing this guidance.  If you cannot identify the appropriate FDA staff, call the 
appropriate number listed on the title page of this guidance.  
Introduction  
This document is intended to provide guidance to mammography facilities and their 
personnel.  It represents the Food and Drug Administrations (FDA) current thinking on 
the final regulations implementing the Mammography Quality Standards Act (MQSA) 
(42 U.S.C. 263b).  This guidance updates the Policy Guidance Help System and addresses 
or contains the following: 
1.  Updated contact information for accreditation bodies and certification agencies; 
2.  General guidance regarding Additional Mammography Reviews (AMRs); 
3.  Previously approved alternative standards; 
4.  Centers for Medicare and Medicaid Services (CMS) reimbursement; 
5.  Mechanisms to inform physicians and patients of mammography results; 
6.  Mammographic modality and its impact on personnel requirements; 
7.  Clarification of the personnel 6-month exemption period; 
8.  Information on calibrating the air kerma measuring instrument; 
9.  Medical physicist involvement as it applies to cassette replacement; 
10. Full Field Digital Mammography (FFDM) and use of single-use cushion pads; 
11. Quality control testing of computer controlled compression devices; 
12. Mammography equipment evaluations of laser printers; 
13. Quality control testing of monitors and laser printers; 
  3  14. Mammography equipment evaluations of new FFDM units; and 
15. Mammography equipment evaluations of off-site laser printers and monitors. 
FDA's guidance documents, including this guidance, 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. 
For purposes of this document, additions to the Policy Guidance Help System (PGHS) are 
shown in red and underlined (Example) while deletions are shown in blue with 
strikethroughs (Example).  Note: Questions and answers that are currently in the PGHS and 
are not being modified are not included in this document. 
Under its own authority, a State may impose more stringent requirements beyond those 
specified under MQSA and its implementing regulations.  A facility may want to check 
with its State or local authorities regarding their requirements. 
Background 
The Mammography Quality Standards Act (MQSA) was signed into law on October 27, 
1992 (Public Law 102-539), to establish national quality standards for mammography.  It 
is codified at 42 U.S.C. 263b.  The MQSA requires that, in order to lawfully provide 
mammography services after October 1, 1994, all facilities, except facilities of the 
Department of Veterans Affairs, must be accredited by an approved accreditation body 
and certified by the Secretary of Health and Human Services (the Secretary) or by an 
approved State certification agency (section 354(b) of the MQSA; 42 USC 263b(b)).  In 
June 1993, the authority to approve accreditation bodies and State certification agencies, 
and to certify facilities, was delegated by the Secretary to the FDA (58 FR 32543).  On 
October 28, 1997, the FDA first published final regulations implementing the MQSA in 
the Federal Register (21 CFR Part 900).  The MQSA has twice been amended since its 
enactment, through the Mammography Quality Standards Reauthorization Acts 
(MQSRAs) of 1998 and 2004 (Public Laws 105-248 and 108-365). 
The draft of this guidance was made available for comment in the Federal Register on 
October 9, 2009.  Four respondents submitted a total of 14 comments on the draft 
guidance.  In addition, the National Mammography Quality Assurance Advisory 
Committee reviewed the draft guidance during its January 25, 2010 meeting and provided 
additional comments.  FDA reviewed and considered all the comments and in response 
FDA has modified the draft guidance by: 
1.  providing the most current accreditation body and certification agency contact 
information 
2.  clarifying that original or lossless compressed digital image files may be 
acceptable for record transfer 
  4  3.  clarifying the conditions under which an Additional Mammography Review 
conducted by an outside entity (AMROE) would be acceptable to FDA 
4.  deleting the question and answer dealing with image labeling 
5.  modifying the section on the use of attestation to include attesting to the 
specific mammographic modality included in personnels initial training 
6.  clarifying the guidance on the use of non-invasive kVp meters 
7.  recommending the inclusion of cushion pad(s) when performing AEC testing 
 
In November 1998, FDA compiled all to-date final FDA guidances related to MQSA and 
put them into a computerized searchable database called the Policy Guidance Help 
System (PGHS).  The PGHS is available on the Internet at: 
http://www.fda.gov/Radiation-
EmittingProducts/MammographyQualityStandardsActandProgram/Guidance/PolicyGuida
nceHelpSystem/default.htm  
FDA periodically updates the information in the PGHS and this document serves as a 
further update.  Individuals wishing to receive automatic notification of future updates 
may subscribe to our E-mail ListServ by visiting  
http://service.govdelivery.com/service/subscribe.html?code=USFDA_45 and following 
the directions there. 
 
The Accreditation and Certification/Accreditation and Certification Overview is 
being modified as follows 
Citation: 
900.11(a)  General.  After October 1, 1994, a certificate issued by FDA is required for 
lawful operation of all mammography facilities subject to the provisions of this subpart.  
To obtain a certificate from FDA, facilities are required to meet the quality standards in 
section 900.12 and to be accredited by an approved accreditation body or other entity as 
designated by FDA. 
Discussion: 
The Mammography Quality Standards Act (MQSA) requires that before a mammography 
facility can legally perform mammography, it must be certified.  Before a facility can be 
certified, it must meet applicable MQSA requirements including those established by its 
accreditation body to obtain accreditation.  To begin the process, the facility must first 
contact its accreditation body and apply for accreditation.     
Currently the The FDA-approved accreditation bodies (ABs) are: 
American College of Radiology (ACR) 
Mammography Accreditation Program 
1891 Preston White Drive 
Reston, Virginia 20191-4397 
  5  1-800-227-6440 
State of Arkansas 
Arkansas Department of Health 
Division of Health 
Radiation Control Section 
Mammography Program 
4815 W. Markham, Slot 30 
Little Rock, Arkansas 72205-3867 
1-501-661-2301 
State of Iowa 
Mammography Accreditation Program 
Bureau of Radiological Health 
Iowa Department of Public Health 
Lucas State Office Bldg., 5th Floor 
321 East 12th Street 
Des Moines, Iowa 50319 
1-515-281-3478 
State of Texas 
Texas Department of State Health Services 
Mammography Accreditation Program 
Machine Source Group  
P.O BOX 149347  
Mail Code 2835  
Austin, TX  78714-9347 
1-512-834-6688 extension 2246 
 
Note: Under MQSA regulations, a facility located in a State approved by FDA as an 
accreditation body (AB) may be accredited by the State AB or by the American College 
of Radiology (ACR). See 21 C.F.R.CFR 900.4(a)(7).  State law may require facilities to 
meet additional requirements.  State requirements are independent of MQSA. See 42 
U.S.C. 263b(m). You may want to contact your State about its requirements. 
The regulations require the AB to review a mammography facility's equipment, personnel 
(interpreting physicians, radiologic technologists, and medical physicists), and practices. 
The AB will accredit the facility if its review establishes that the mammography facility 
meets the quality standards established under MQSA. 21 C.F.R.CFR 900.4. 
Certification is a process separate from accreditation.  It is administered by a Certifying 
Agency (FDA or an FDA-approved Certifying State Certifying Agency(SCA)). 21 CFR 
900.21.  FDA generally does will not certify facilities located in states that have an FDA-
approved SCA Certifying States.  Certifying States SCAs only certify facilities within 
their State borders.  Currently tThe FDA-approved Certifying States SCAs are: 
  6  State of Illinois 
Office of Radiation Safety 
Division of Registration and Certification 
Department of Nuclear Safety 
1035 Outer Park Drive 
Springfield, IL 62704 
217-785-9974 
State of Iowa 
Mammography Accreditation Certification Program 
Bureau of Radiological Health 
Iowa Department of Public Health 
Lucas State Office Bldg., 5th Floor 
321 East 12th Street 
Des Moines, Iowa 50319 
515-281-3478 
State of South Carolina 
Mammography Certification Program 
Department of Health and Environmental Control 
Bureau of Radiological Health 
Division of Electronic Products 
2600 Bull Street 
Columbia, SC 29201 
803-545-4400 
 
State of Texas 
Texas Department of State Health Services 
Mammography Certification Program 
Machine Source Group  
P.O BOX 149347  
Mail Code 2835  
Austin, TX  78714-9347 
512-834-6688, Extension 2245 
Question 15:  Which FFDM units can be accredited by which accreditation bodies? 
The American College of Radiology has been approved to accredit the General Electric 
Senographe 2000D, General Electric Senographe DS, Fischer SenoScan, Lorad/Hologic 
Selenia, Selenia S and Selenia Dimensions 2D, Siemens Mammomat Novation DR and 
Novation S, General Electric Senographe Essential, and Fuji Computed Radiography 
FFDM units. 
  7  The State of Arkansas has been approved to accredit the Lorad/Hologic Selenia, Selenia S 
and Selenia Dimensions 2D, General Electric Senographe 2000D, General Electric 
Senographe DS, General Electric Essential, Siemens Mammomat Novation DR and 
Novation S, and Fuji Computed Radiography FFDM units.  
The State of Iowa has been approved to accredit the General Electric Senographe 2000D, 
General Electric Senographe DS, General Electric Senographe Essential, Lorad/Hologic 
Selenia, Selenia S and Selenia Dimensions 2D, Siemens Mammomat Novation DR and 
Novation S, and Fuji Computed Radiography FFDM units. 
The State of Texas has been approved to accredit the General Electric Senographe 
2000D, General Electric Senographe DS, General Electric Senographe Essential, Fischer 
SenoScan, Lorad/Hologic Selenia, Selenia S and Selenia Dimensions 2D, Siemens 
Mammomat Novation DR and Novation S, and Fuji Computed Radiography FFDM units. 
The following question and answer is being added to Accreditation and 
Certification/Application to an Accreditation Body 
Citation: 
900.11(b)(1)(i)(ii):  Application.  
(1)   Certificates. 
(i)   In order to qualify for a certificate, a facility must apply to an FDA-approved 
accreditation body, or to another entity designated by FDA.  The facility shall submit to 
such body or entity the information required in 42 U.S.C. 263b(d)(1).  
(ii)   Following the agencys receipt of the accreditation bodys decision to accredit a 
facility, or an equivalent decision by another entity designated by FDA, the agency may 
issue a certificate to the facility, or renew an existing certificate, if the agency determines 
that the facility has satisfied the requirements for certification or recertification. 
Question 12: We are planning on moving our mammography unit.  Whom do we 
need to notify about the move? 
The answer to the question is available in a table on the following webpage:  
http://www.fda.gov/Radiation-
EmittingProducts/MammographyQualityStandardsActandProgram/Guidance/ucm219621.
htm  
Question #4 in Accreditation and Certification/Accreditation and Certification 
Overview, Question #5 in Accreditation and Certification/Definition of Certificate 
and Question #5 in Definitions/Certificate are being modified as follows 
Question: What should a facility do if it closes or decides that it will no longer 
provide mammography services? 
  8  Before a facility permanently stops performing mammography, it should do the 
following: 
1.  Inform its accreditation body that it will no longer be performing mammography; 
2.  Notify its State radiation control program; and 
3.  Arrange transfer of each patients medical record (original mammography films 
and/or original or lossless compressed digital files and reports) to the mammography 
facility where the patient will be receiving future care, the patients referring physician or 
health care provider, or the patient.  This transfer will address the statutory and regulatory 
requirement that the facility maintain the patients permanent medical record for a period 
of not less than 5 years, or not less than 10 years if no additional mammograms are 
performed at the facility, or longer if mandated by State or local law.  42 U.S.C. 
263b(f)(2)(G)(i)(I); 21 CFR 900.12(c)(4).  The facility should make reasonable attempts 
to inform its former patients of how they can obtain their mammography records.  
Facilities should check with State or local agencies to determine if their whether State or 
local requirements are more stringent than those of MQSA.  Note: Radiology practices 
and other medical facilities that still see patients but have permanently stopped 
performing mammography, may choose to keep the patients medical records rather than 
transfer them to another facility (unless the patient requests such a transfer). 
If option transfer of each patient's medical record (step 3) is not viable, facilities could 
store the medical records in a hospital, if appropriate, or make arrangements to warehouse 
the records.  The facility should assure that there is a mechanism to release the films 
records to the appropriate entity when requested and that former patients are made aware 
of that mechanism.  It should be noted that if no one else is willing to accept the records, 
the facility remains responsible for them.  Under MQSA, facilities will not be held 
responsible for maintenance of examinations performed before October 1, 1994; 
however, State and local regulations may require otherwise. 
Once the facility ceases operation, the MQSA certificate should no longer be displayed.  
The facility may file or destroy its MQSA certificate. 
Due to the fact that some facilities have not followed the above recommendations, FDA 
has received inquiries from patients complaining that their mammography facility has 
closed, that they were not informed, and that they cannot find out where or how to gain 
access to their mammography records.  For this reason, FDA requests that a facility that 
plans to stop performing mammography notify its Certifying Agency of how it intends to 
fulfill its obligations with respect to medical records.  Such information may be sent to: 
FDA/CDRH/OCER/DMQRP 
Attention:  Closed Facility Notification of Records Retention 
1350 Piccard Drive, HFZ-240 
Rockville, MD  20850 
  9  10903 New Hampshire Avenue 
WO66-4621 
Silver Spring, MD 20993 
Facilities certified by States may send the above information to: 
State of Illinois 
Office of Radiation Safety 
Division of Registration and Certification 
Department of Nuclear Safety 
1035 Outer Park Drive 
Springfield, IL 62704 
217-785-9974 
State of Iowa 
Mammography Accreditation Certification Program 
Bureau of Radiological Health 
Iowa Department of Public Health 
Lucas State Office Bldg., 5th Floor 
321 East 12th Street 
Des Moines, Iowa 50319 
515-281-3478 
State of South Carolina 
Mammography Certification Program 
Department of Health and Environmental Control 
Bureau of Radiological Health 
Division of Electronic Products 
2600 Bull Street 
Columbia, SC 29201 
803-545-4400 
 
State of Texas 
Texas Department of State Health Services 
Mammography Certification Program 
Machine Source Group  
P.O BOX 149347  
Mail Code 2835  
Austin, TX  78714-9347 
512-834-6688, Extension 2245 
The following question and answer is being modified in Accreditation and 
Certification/Full Field Digital Mammography Certification Extension Program 
Question 9:  Which FFDM units can be accredited by which accreditation bodies? 
  10  The American College of Radiology has been approved to accredit the General Electric 
Senographe 2000D, General Electric Senographe DS, Fischer SenoScan, Lorad/Hologic 
Selenia, Selenia S and Selenia Dimensions 2D, Siemens Mammomat Novation DR and 
Novation S, General Electric Senographe Essential, and Fuji Computed Radiography 
FFDM units. 
The State of Arkansas has been approved to accredit the Lorad/Hologic Selenia, Selenia S 
and Selenia Dimensions 2D, General Electric Senographe 2000D, General Electric 
Senographe DS, General Electric Essential, Siemens Mammomat Novation DR and 
Novation S, and Fuji Computed Radiography FFDM units.  
The State of Iowa has been approved to accredit the General Electric Senographe 2000D, 
General Electric Senographe DS, General Electric Senographe Essential, Lorad/Hologic 
Selenia, Selenia S and Selenia Dimensions 2D, Siemens Mammomat Novation DR and 
Novation S, and Fuji Computed Radiography FFDM units. 
The State of Texas has been approved to accredit the General Electric Senographe 
2000D, General Electric Senographe DS, General Electric Senographe Essential, Fischer 
SenoScan, Lorad/Hologic Selenia, Selenia S and Selenia Dimensions 2D, Siemens 
Mammomat Novation DR and Novation S, and Fuji Computed Radiography FFDM units. 
The following is being modified in Additional Mammography Review and Patient 
Notification/AMR General Guidance 
AMR General Guidance for 
Additional Mammography Review 
Background 
The Food and Drug Administration (FDA) developed this Additional Mammography 
Review (AMR) guidance to inform facilities of possible FDA actions when FDA believes 
that mammography quality at a facility has been compromised and may present a serious 
risk to human health.  Information that could cause FDA to suspect that quality may have 
been compromised could include: 
1.  An MQSA inspections with a level 1 inspection observation show a Level 1 
finding for phantom image testing 
2.  An MQSA inspection with a level 1 inspection observation for or interpreting 
physician qualifications. 
3.  Extensive failures to comply with the equipment quality assurance requirements 
under 21 CFR 900.12(e) 
4.  Evidence or information obtained from a facilitys accreditation body or from 
physician, patient, or technologist complaints regarding a quality problem at the 
facility 
  11  5.  Evidence that records demonstrating compliance with the quality standards under 
21 CFR 900.12 have been falsified 
6.  Performance of mammography without an MQSA certificate 
A Llevel 1 finding inspection observation represents a deviation from MQSA standards 
that may seriously compromise the quality of mammography services offered by the 
facility.  FDA has determined that these specific Llevel 1 findings, as well as the other 
examples listed above, are indicators that serious quality problems may be present at the 
facility and require further evaluation.  An assessment of the quality of mammograms 
produced by the facility is performed to assess should indicate whether any of the 
equipment problems noted above that resulted in the Level 1 phantom image finding have 
affected clinical image quality.  A Llevel 1 finding observation for the phantom image 
test exists when the score is less than 3 fibers, less than 2 speck groups, and/or less than 2 
masses.  Regarding interpreting physician qualifications, an assessment of mammograms 
and mammography reports may indicate whether failure to meet specific personnel 
standards has affected the quality of mammographic interpretations findings.  If FDA 
determines that the problems rise to the level of a significant risk to human health, FDA 
may require the facility to notify patients and their referring physicians of the 
deficiencies, the potential harm resulting, appropriate remedial measures, and such other 
relevant information as FDA may require. 
In addition to these two specific inspection findings, other problems could result in FDA 
requiring AMR for a facility.  For example, evidence or information may be obtained 
from a facilitys accreditation body or patient or physician complaints that could convince 
FDA to require an AMR.  In the case where serious quality problems are suspected at a 
facility, FDA may require that the facility undertake an investigation of the impact of 
these findings on the clinical images produced by the facility or of the interpretations 
rendered by the interpreting physician.  If FDA determines that the problems rise to the 
level of a significant risk to human health, FDA may require the facility to undertake 
patient/physician notification. 
This authority is stated as follows (21 C.F.R.CFR 900.12(j)): 
Additional Mammography Review and Patient Notification 
(1)  If FDA believes that mammography quality at a facility has been compromised 
and may present a serious risk to human health, the facility shall provide clinical 
images and other relevant information, as specified by FDA, for review by the 
accreditation body or other entity designated by FDA.  This additional 
mammography review will help the agency to determine whether the facility is in 
compliance with this section and, if not, whether there is a need to notify affected 
patients, their physicians, or the public that the reliability, clarity, and accuracy 
of interpretation of mammograms has been compromised. 
  12  (2)   If FDA determines that the quality of mammography performed by a facility, 
whether or not certified under Sec. 900.11, was so inconsistent with the quality 
standards established in this section as to present a significant risk to individual 
or public health, FDA may require such facility to notify patients who received 
mammograms at such facility, and their referring physicians, of the deficiencies 
presenting such risk, the potential harm resulting, appropriate remedial 
measures, and such other relevant information as FDA may require. Such 
notification will occur within a timeframe and in a manner specified by FDA. 
There are two specific types of AMR identified in the regulations and this policy.  These 
are AMR Conducted by the Facility (AMRFAMROE) and They are an AMR Cconducted 
by the facilitys Aaccreditation Bbody which we refer to as an (AMRAB) and an AMR 
conducted by another entity which we refer to as an AMROE.  Under AMRAB, the 
facilitys accreditation body is asked to conduct the AMR.  Under AMRFAMROE, FDA 
works with the facility to identify a qualified reviewing interpreting physician(s) to 
perform the AMR.  The physician(s) is subject to FDA approval. 
Facilities subject to an AMR may also be subject to other regulatory and enforcement 
actions by FDA, for example a Directed Plan of Correction (DPC) to correct violations in 
a timely manner or a patient and physician notification.  See 42 U.S.C. 263b(h) and (i) for 
other actions, including civil money penalties, or suspension or revocation of 
certification, that FDA may impose on facilities. 
  Under AMRAB, the facilitys accreditation body is asked to conduct the AMR. 
This policy does not prevent FDA from taking legal actions against facilities, in addition 
to AMR, where the use of an MQSA sanction may be necessary to compel a facility to 
comply with FDA regulatory requirements.  As an example, FDA may issue a Directed 
Plan of Correction (DPC) to a facility to address serious problems at the facility. The 
DPC may require the facility to take specific corrective actions. 42 U.S.C. 263b(h)(1)(A). 
FDA may require the facility to notify patients and/or their referring physicians of facility 
problems, in the event the AMR indicates mammography quality problems are present 
that would justify such a notification. 
Note:  The interpreting physician(s) conducting the image review for AMRAB AMRF or 
AMROE AMRAB should not have a relationship with the facility, conduct the 
review when it would or otherwise be have a conflict of interest for them to do so, 
or when they have a bias in favor of or against the facility.  Before the facility's 
accreditation body (AB) conducts AMRAB, the AB may require reimbursement 
of its expenses for the AMRAB.  In this case, the AB should notify the facility 
accordingly, including an of the estimated of the cost and other relevant 
information, such as whether payment must be received to conduct the AMRAB.  
The AB may also require payment prior to the start of the AMRAB. 
If a facility has a Level 1 phantom image finding or a Level 1 interpreting physician 
finding, FDA may require the facility to undergo an AMR.  Because the AB already has 
procedures and personnel in place for performing AMRs, this type of AMR will generally 
  13  be the preferred method.  However, if FDA considers it appropriate, it may propose an 
AMRFAMROE, or accept a facilitys proposal for an AMROE.  In an AMROE, FDA 
would specify The facility would then provide FDA with specific details as to how the 
AMR would be conducted (including timeframes), how the patient exams would be 
selected, and the qualifications of the reviewing proposed interpreting physician(s) 
(including the physicians specialized training in evaluating clinical image quality).  FDA 
would work with the facility to identify an acceptable reviewing physician(s).  If an 
AMROE acceptable to FDA cannot be arranged FDA does not approve the facilitys 
proposal, the facility must undergo AMRAB. 
Evaluations of Inspection Findings Leading Observations that May Lead to an AMR and 
Patient and/ Physician Notification: 
  All level 1 observations for phantom image test results at Level 1 will be testing 
are confirmed through a second review by an the MQSA auditor or an FDA 
MQSA inspector (or by the State, if the State has a thorough phantom image 
quality assurance (QA) program in place).  For those cases where there are no 
second reviewers available, the Division of Mammography Quality and Radiation 
Programs (DMQRP) will provides the second review. 
  After confirmation of the level 1 observation that a physician was not board 
certified and did not have initial training in mammography and/or never had a 
valid license to practice medicine or the license to practice medicine was revoked, 
FDA will evaluate the findings to determines whether an AMR is appropriate 
based on the seriousness of the violations. 
  After confirmation of the Llevel 1 finding inspection observation(s), a Warning or 
Untitled Letter may be sent to FDA may notify the facility in writing that it must 
undergo AMR. 
  The Warning or Untitled AMR Lletter should advises the facility that it must is 
required to undergo an AMR, that it will may be responsible for the cost of the 
AMR, and that further details (including how the AMR will be conducted whether 
an AMRF or AMRAB will be required) will follow in a letter from FDA and/or 
the AB. The type (AMRAB or AMRFAMROE) and scope of the AMR are will be 
determined by FDA (usually after consultation with the facilitys AB). 
  If the results of the AMR indicate that the quality of mammographic images or 
interpretations at the facility was so inconsistent with the quality standards as to 
represent a significant risk to human health, FDA may require the facility to 
undertake a patient and referring physician notification of patients and/or referring 
physicians.   
  14    If the results of the AMR do not indicate a significant risk to human health, FDA 
will evaluates the results of the AMR to determine if additional follow-up or 
monitoring is necessary. 
  FDA also assesses whether to take other regulatory and enforcement actions, as 
needed. 
Approved Alternative Standards/Requirements 
All the approved alternative standards can be found on the following webpage: 
http://www.fda.gov/Radiation-
EmittingProducts/MammographyQualityStandardsActandProgram/Regulations/ucm1108
80.htm  
The following question and answer is being added to Equipment/X-Ray Film 
Citation: 
900.12(b)(11):  X-ray film.  The facility shall use X-ray film for mammography that has been 
designated by the film manufacturer as appropriate for mammography. 
Question 2: Are we required to use a specific type of laser film when printing full field 
digital images? 
While there is a requirement in 21 CFR 900.12(b)(11) that the x-ray film used for screen-film 
mammography be designated as appropriate for mammography, there is no similar 
requirement for the laser film used to print full field digital mammography hardcopy images.  
However, FDA recommends that facilities use laser film compatible with the printer being 
used, and designated for FFDM use by the laser film manufacturer or recommended by the 
FFDM manufacturer.  Under 21 CFR 900.12(e)(6), laser film used for hardcopy must 
produce images of final interpretation quality that pass the applicable QC tests listed in the 
FFDM manufacturers QC manual. 
The following question and answer is being added to CMS (Formerly HCFA)/Centers 
for Medicare and Medicaid Services (CMS) (formerly HCFA) Reimbursement As It 
Relates to MQSA Certification 
Question 2: If our facility is having difficulty being reimbursed by Medicare for 
mammography services, whom should we contact? 
The answer to this question is available on the following webpage: 
http://www.fda.gov/Radiation-
EmittingProducts/MammographyQualityStandardsActandProgram/ConsumerInformation/uc
m113956.htm  
The following question and answer is being modified in Medical Records and 
Reports/Communication of Results to Patients  
  15  Citation:   
900.12(c)(2)(i),(ii):  Communication of mammography results to the patients. Each facility 
shall send each patient a summary of the mammography report written in lay terms within 30 
days of the mammographic examination. If assessments are ``Suspicious'' or ``Highly 
suggestive of malignancy,'' the facility shall make reasonable attempts to ensure that the 
results are communicated to the patient as soon as possible. 
(i)  Patients who do not name a health care provider to receive the mammography report 
shall be sent the report described in paragraph (c)(1) of this section within 30 days, in 
addition to the written notification of results in lay terms. 
(ii)  Each facility that accepts patients who do not have a health care provider shall 
maintain a system for referring such patients to a health care provider when clinically 
indicated.  
Question 2:  What criteria will FDA use to determine that facilities meet the MQSA 
requirements for providing lay summaries and mammography reports to their patients 
and health care providers? 
 
One way to meet the requirements for providing lay summaries and mammography reports is 
for facilities to can either: have Provide written documentation describing the procedures for 
all of the following:  
  providing (sending or giving) the written lay summary to patients within 30 days of 
the examination. 
  providing the mammography report to the health care provider (or the patient, if self 
referred) within 30 days of the examination.  
  communicating the results of positive (suspicious or highly suggestive of malignancy) 
examinations to patients and health care providers as soon as possible (FDA recommendsas 
guidance, within 5 and 3 business days of the date of interpretation, respectively).  This 
communication may be verbal or written.  If verbal, it must be followed by a written lay 
summary and mammography report provided within 30 days of the examination. 
AND either 
1.  Demonstrate to the inspector that: 
  the facility is notifying patients and health care providers of positive examinations as 
soon as possible (FDA recommendsas guidance, within 5 and 3 business days of the date of 
interpretation, respectively). In the case of verbal communication, this may be done by 
documenting such communication in the mammography report or in logs. In the case of 
written communication, see next two bulleted items. 
  the facility is providing written mammography reports.   This may be done by having 
copies of the mammography report available within 30 days of the examination (positive 
mammography reports should be available within 3 business days of the date of 
interpretation). 
  the facility is providing written lay summaries. This may be done by having copies of 
the lay summary available within 30 days of the examination (positive lay summaries should 
be available within 5 business days of the date of interpretation).  If the facility does not keep 
copies of the patients' lay summaries, it may document such communication in the 
  16  mammography report, or in logs, or by stating in the facility's Quality Assurance (QA) 
manual that the lay summary is provided within the appropriate time frames. 
OR 
2.  For facilities with computerized reporting systems, provide the inspector with a list or 
print-out documenting that all lay summaries and mammography reports have been sent out 
within the 30 day timeframe and that all positive results have been communicated, either 
verbally or by means of the written report, to patients and health care providers as soon as 
possible (FDA recommends within 5 and 3 business days of the date of interpretation, 
respectively).  
The following question and answer is being modified in Medical Records and 
Reports/Communication of Results to Providers 
Citation: 
900.12(c)(3)(i),(ii):  Communication of mammography results to health care providers.  
When the patient has a referring health care provider or the patient has named a health 
care provider, the facility shall:   
(i)  Provide a written report of the mammography examination, including the items 
listed in paragraph (c)(1) of this section, to that health care provider as soon as possible, 
but no later than 30 days from the date of the mammography examination; and  
(ii)  If the assessment is "Suspicious" or "Highly suggestive of malignancy," make 
reasonable attempts to communicate with the health care provider as soon as possible, or 
if the health care provider is unavailable, to a responsible designee of the health care 
provider.  
Question 2:   What criteria will FDA use to determine that facilities meet the MQSA 
requirements for providing lay summaries and mammography reports to their 
patients and health care providers? 
One way to meet the requirements for providing lay summaries and mammography reports is 
for facilities to can either: have Provide written documentation describing the procedure for 
all of the following:  
  providing (sending or giving) the written lay summary to patients within 30 days of 
the examination. 
  providing the mammography report to the health care provider (or the patient, if self 
referred) within 30 days of the examination.  
  communicating the results of positive (suspicious or highly suggestive of malignancy) 
examinations to patients and health care providers as soon as possible (FDA recommendsas 
guidance, within 5 and 3 business days of the date of interpretation, respectively).  This 
communication may be verbal or written.  If verbal, it must be followed by a written lay 
summary and mammography report provided within 30 days of the examination. 
AND either 
1.  Demonstrate to the inspector that: 
  the facility is notifying patients and health care providers of positive examinations as 
soon as possible (FDA recommendsas guidance, within 5 and 3 business days of the date of 
  17  interpretation, respectively). In the case of verbal communication, this may be done by 
documenting such communication in the mammography report or in logs. In the case of 
written communication, see next two bulleted items. 
  the facility is providing written mammography reports.   This may be done by having 
copies of the mammography report available within 30 days of the examination (positive 
mammography reports should be available within 3 business days of the date of 
interpretation). 
  the facility is providing written lay summaries. This may be done by having copies of 
the lay summary available within 30 days of the examination (positive lay summaries should 
be available within 5 business days of the date of interpretation).  If the facility does not keep 
copies of the patients' lay summaries, it may document such communication in the 
mammography report, or in logs, or by stating in the facility's Quality Assurance (QA) 
manual that the lay summary is provided within the appropriate time frames. 
OR 
2.  For facilities with computerized reporting systems, provide the inspector with a list or 
print-out documenting that all lay summaries and mammography reports have been sent out 
within the 30 day timeframe and that all positive results have been communicated, either 
verbally or by means of the written report, to patients and health care providers as soon as 
possible (FDA recommends within 5 and 3 business days of the date of interpretation, 
respectively). 
The following questions and answers are being added to Medical Records and 
Reports/Communication of Results to Patients and Medical Records and 
Reports/Communication of Results to Providers 
Questions 24 and 7: Are there any additional issues we should be aware of when 
providing mammography results to referring healthcare providers and patients? 
FDA has occasionally identified problems with the methods that some facilities use to 
provide mammography results to referring healthcare providers and patients. While the vast 
majority of facilities have adequate written standard operating procedures (SOPs) regarding 
the provision of mammography reports and lay summaries to referring healthcare providers 
and patients, some facilities do not track or monitor the issuance of the reports and/or lay 
summaries.  Consequently, some referring healthcare providers and patients are not receiving 
their examination results or are not receiving them in a timely manner.  
MQSA allows facilities to develop or use a procedure and tracking system that works best for 
them. Facilities should monitor their systems to ensure that their policies and procedures are 
being followed. FDA supports the use of computer tracking and paper or patient log systems 
to assist in tracking timely issuance of medical reports and lay summaries. Some radiology 
computer reporting systems can track individual reports and generate summary reports 
indicating when a mammography report or lay summary has been issued or is overdue. By 
routinely checking these summary reports, facilities can ensure that all mammography results 
have been issued in a timely manner. FDA encourages facilities (1) to check with their 
computer support vendors to determine whether their software can generate these types of 
  18  reports, and (2) to routinely assess their system(s) to ensure that these systems consistently 
document issuing mammography lay summaries and reports to all patients and their referring 
healthcare providers within the required timeframe.  
Facilities that fax or email medical reports and/or lay summaries should have policies and 
procedures in place to ensure that, if any faxes or emails are reported as delivery 
failure, the reports and lay summaries are re-sent in a timely manner. 
Questions 25 and 8: If a mammogram is interpreted as Suspicious or Highly 
Suggestive of Malignancy (a positive mammogram) the mammography report and lay 
summary are to be provided as soon as possible.  Previously issued guidance mentions 
3-5 days.  Is that measured from the date of the mammogram or the date the 
mammogram was interpreted as positive? 
The 3-5 day time period should start from the date that a facility interprets the 
mammogram as positive. In guidance we state that a facility should notify referring 
healthcare providers and patients within 3-5 days and that the facility should be able to 
justify its actions if it takes longer. Some facilities have incorrectly interpreted this 
guidance as referring to 3-5 days from the date of the performance of the mammogram 
rather than 3-5 days from the date the mammogram is interpreted as being positive.  
Because the regulations do not identify when a facility is required to read the 
mammogram (only that the mammography report and lay summary must be sent within 
30 days after the mammogram is performed), the facility should use the mammography 
report date, not the mammogram exam date, to determine if it has made reasonable 
attempts to communicate the positive mammogram results as soon as possible. 
Example: A facility performs a mammogram on 10/1/2007 which is read and interpreted 
on 10/12/2007. The mammography assessment for this mammogram is Suspicious (a 
positive mammogram). The facility mails both the patient lay summary and the 
mammography report on 10/14/2007.  The facility has met the requirement to make 
reasonable attempts to communicate the positive mammogram results as soon as possible 
because it has provided the mammography report and the patient lay summary within two 
days of making the assessment that the mammogram was positive.  Furthermore, it has 
met the requirement that the mammography report and the patient lay summary be 
provided within 30 days of the date of the examination. 
The following question and answer is being added to Personnel/General/Attestation 
- Acceptable Uses for Personnel Requirements 
Applicable Citations:  
900.12(a)(1)(ii)(B):  All interpreting physicians shall maintain their qualifications by 
meeting the following requirement: Following the third anniversary date of the end of the 
calendar quarter in which the requirements of paragraph (a)(1)(i) of this section were 
  19  completed, the interpreting physician shall have taught or completed at least 15 category 
I continuing medical education units in mammography during the 36 months immediately 
preceding the date of the facilitys annual MQSA inspection or the last day of the 
calendar quarter preceding the inspection or any date in between the two.  The facility 
will choose one of these dates to determine the 36-month period.  This training shall 
include at least six category I continuing medical education credits in each 
mammographic modality used by the interpreting physician in his or her practice. 
900.12(a)(1)(ii)(C) Before an interpreting physician may begin independently 
interpreting mammograms produced by a new mammographic modality, that is, a 
mammographic modality in which the physician has not previously been trained, the 
interpreting physician shall have at least 8 hours of training in the new mammographic 
modality. 
900.12(a)(1)(iv)(B):  Interpreting physicians who fail to meet the continuing education 
requirements of paragraph (a)(1)(ii)(B) of this section shall obtain a sufficient number of 
additional category I continuing medical education credits in mammography to bring 
their total up to the required 15 credits in the previous 36 months before resuming 
independent interpretation. 
900.12(a)(2)(iii)(A) and (C):  Continuing Education Requirements:   
(A)  Following the third anniversary date of the end of the calendar quarter in which 
the requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section were completed, the 
radiologic technologist shall have taught or completed at least 15 continuing education 
units in mammography during the 36 months immediately preceding the date of the 
facilitys annual MQSA inspection or the last day of the calendar quarter preceding the 
inspection or any date in between the two.  The facility will choose one of these dates to 
determine the 36-month period.   
(C)  At least six of the continuing education units required in paragraph (a)(2)(iii)(A) 
of this section shall be related to each mammographic modality used by the technologist. 
900.12(a)(2)(iii)(D):  Requalification.  Radiologic technologists who fail to meet the 
continuing education requirements of paragraph (a)(2)(iii)(A) of this section shall obtain 
a sufficient number of continuing education units in mammography to bring their total up 
to at least 15 in the previous 3 years, at least 6 of which shall be related to each modality 
used by the technologist in mammography.  The technologist may not resume performing 
unsupervised mammography examinations until the continuing education requirements 
are completed. 
900.12(a)(3)(iii)(A):  Continuing education.  Following the third anniversary date of the 
end of the calendar quarter in which the requirements of paragraph (a)(3)(i) or (a)(3)(ii) 
of this section were completed, the medical physicist shall have taught or completed at 
least 15 continuing education units in mammography during the 36 months immediately 
  20  preceding the date of the facilitys annual inspection or the last day of the calendar 
quarter preceding the inspection or any date between the two.  The facility shall choose 
one of these dates to determine the 36-month period.  This continuing education shall 
include hours of training appropriate to each mammographic modality evaluated by the 
medical physicist during his or her surveys or oversight of quality assurance programs.  
Units earned through teaching a specific course can be counted only once towards the 
required 15 units in a 36-month period, even if the course is taught multiple times during 
the 36 months. 
900.12(a)(3)(iii)(C) Before a medical physicist may begin independently performing 
mammographic surveys of a new mammographic modality, that is, a mammographic 
modality other than one for which the physicist received training to qualify under 
paragraph (a)(3)(i) or (a)(3)(ii) of this section, the physicist must receive at least 8 hours 
of training in surveying units of the new mammographic modality. 
900.12(a)(3)(iv)(A):  Medical physicists who fail to maintain the required continuing 
qualifications of paragraph (a)(3)(iii) of this section may not perform the MQSA surveys 
without the supervision of a qualified medical physicist.  Before independently surveying 
another facility, medical physicists must reestablish their qualifications as follows:  (A) 
Medical physicists who fail to meet the continuing educational requirements of 
paragraph (a)(3)(iii)(A) of this section shall obtain a sufficient number of continuing 
education units to bring their total units up to the required 15 in the previous 3 years. 
Question 1: My initial mammography training documentation does not specify 
whether the training was in screen-film or full field digital.  Will I have to go back to 
my training program to get additional documentation or will I be able to attest to 
which mammographic modality I was trained in? 
While personnel generally cannot attest to initial training, in cases where the 
documentation meets the regulatory requirement but is deficient in identifying the 
mammographic modality, FDA will accept an attestation. 
Citation:  
900.12(a)(1)(ii)(A): All interpreting physicians shall maintain their qualifications by 
meeting the following requirement: Following the second anniversary date of the end of 
the calendar quarter in which the requirements of paragraph (a)(1)(i) of this section were 
completed, the interpreting physician shall have interpreted or multi-read at least 960 
mammographic examinations during the 24 months immediately preceding the date of the 
facilitys annual MQSA inspection or the last day of the calendar quarter preceding the 
inspection or any date in-between the two.  The facility will choose one of these dates to 
determine the 24-month period. 
Question 9: I am qualified to interpret screen-film mammograms independently but 
I also interpreted some FFDM mammograms while under direct supervision.  Can I 
count those FFDM mammograms toward my continuing experience requirement? 
  21  Yes. 
The following questions and answers are being added to Personnel/Interpreting 
Physician/ Interpreting Physician Initial Experience 
Citation: 
900.12(a)(1)(i)(D): The interpreting physician shall have interpreted or multi-read at 
least 240 mammographic examinations within the 6-month period immediately prior to 
the date that the physician qualifies as an interpreting physician.  This interpretation or 
multi-reading shall be under the direct supervision of an interpreting physician. 
Question 3: I am a physician who wishes to become initially qualified as an 
interpreting physician. I completed my three months of initial mammography 
training in screen-film mammography and read 240 mammograms during the last 
six months of the residency program under direct supervision but all the 
examinations were performed on a full field digital mammographic (FFDM) unit.  
Does this satisfy the regulatory requirement? 
Yes. While FDA recommends that personnel obtain initial experience using the same 
mammographic modality as used for the initial qualifications, the regulations do not 
specifically require it.  Therefore, examinations read for the initial experience 
requirement do not have to be in the same mammographic modality as examinations read 
for the initial qualification.  
Question 4: I am the physician in question 3.  Once Ive completed my initial 
requirements, can I independently read both screen-film and FFDM examinations? 
No.  Because your initial training was only in screen-film, under MQSA you are qualified 
to read only screen-film examinations independently.  In order to read FFDM 
examinations, you will need to obtain and document eight hours of training in FFDM. 
900.12(a)(1)(ii)(C). 
The following questions and answers are being added to Personnel/Interpreting 
Physician/Interpreting Physician New Mammographic Modality Training 
Citation: 
900.12(a)(1)(ii)(C): Before an interpreting physician may begin independently 
interpreting mammograms produced by a new mammographic modality, that is, a 
mammographic modality in which the physician has not previously been trained, the 
interpreting physician shall have at least 8 hours of training in the new mammographic 
modality. 
Question 11: I am a physician who wishes to become initially qualified as an 
interpreting physician. I completed my three months of initial mammography 
  22  training in screen-film mammography and read 240 mammograms during the last 
six months of the residency program under direct supervision but all the 
examinations were performed on an FFDM unit.  Does this satisfy the regulatory 
requirement? 
Yes. While FDA recommends that personnel obtain initial experience using the same 
mammographic modality as used for the initial qualification, the regulations do not 
specifically require it.  Therefore, examinations read for the initial experience 
requirement do not have to be in the same mammographic modality as examinations used 
for the initial qualification.  
Question 12: I am the physician in question 11.  Once Ive completed my initial 
requirements, can I independently read both screen-film and FFDM examinations? 
No.  Because your initial training was only in screen-film, under MQSA you are qualified 
to read only screen-film examinations independently.  In order to read FFDM 
examinations, you will need to obtain and document eight hours of training in FFDM.  
900.12(a)(1)(ii)(C). 
The following is being added at the end of the discussion section of 
Personnel/Interpreting Physician/Reestablishing the Interpreting Physician 
Continuing Experience Requirement 
Citation: 
900.12(a)(1)(iv)(A)(1)(2) and (3): Interpreting physicians who fail to meet the continuing 
experience requirements of paragraph (a)(1)(ii)(A) of this section shall:  
(1)  Interpret or multi-read at least 240 mammographic examinations under the direct 
supervision of an interpreting physician, or  
(2)  Interpret or multi-read a sufficient number of mammographic examinations, 
under the direct supervision of an interpreting physician, to bring the physician 
s total up to 960 examinations for the prior 24 months, whichever is less.   
(3)  The interpretations required under paragraph (a)(1)(iv)(A)(1) or (a)(1)(iv)(A)(2) 
of this section shall be done within the 6 months immediately prior to resuming 
independent interpretation. 
When an interpreting physician (IP) fails to meet the continuing experience requirement 
of reading 960 mammograms in the previous 24 months, the regulation requires that he 
or she not read mammograms independently until he or she re-qualifies. The IP can re-
qualify by reading, within a 6-month period under direct supervision, either 240 
mammograms or the balance needed to bring the total to 960. FDA considers the 
previous 24 months to begin from the facility inspection date, or the date of the most 
recent calendar quarter preceding the inspection, or any date in between. 
  23  When a facility is inspected within the 6-month period following the date the IP re-
qualified, FDA does NOT intend to cite the facility if the IP has not read a total of 960 
mammograms for the previous 24 months. We consider this a 6-month exemption 
period. However, if a facility is inspected any time after the 6-month exemption period 
has expired (even one day after) and the IP has not read a total of 960 mammograms for 
the previous 24 months, FDA DOES intend to cite the facility. In summary, as long as the 
IP has read at least 960 mammograms by the facility's next inspection, the IP is compliant 
with MQSA regulations. 
Example #1: An IP has been interpreting mammograms for more than two years and is 
hired by a new facility on 9/3/2007. The IP has read only 150 mammograms since 
7/1/2005. She reads 240 mammograms under direct supervision by 9/25/2007. The 
facility is inspected on 1/15/2008. At the time of the inspection, this IP has read 590 
mammograms, which includes the 240 under supervision, since 7/1/2005. Should the 
facility be cited? 
No, because the IPs continuing experience requirement falls under the 6-month 
exemption period, which expires on 3/24/2008. 
Example #2: This same facility is inspected on 4/15/2008 and the IP has read 790 
mammograms, which includes the 240 under supervision, since 4/1/2006. Should the 
facility be cited? 
Yes, because the 6-month exemption period after requalification has passed and the IP 
has not read the required 960 mammograms. 
Example #3: This same facility is inspected on 4/15/2008 and the IP has read 960 
mammograms, which includes the 240 under direct supervision, since 4/1/2006, but the 
IP had read only 600 mammograms by 3/31/08 (a date after the 6-month exemption 
period).  Should the facility be cited? 
No, because the IP has read the required 960 mammograms by the date of the inspection. 
The following question and answer is being added to Personnel/Medical 
Physicist/Medical Physicist Continuing Experience 
Citation: 
900.12(a)(3)(iii)(B):  Continuing experience.  Following the second anniversary date of 
the end of the calendar quarter in which the requirements of paragraphs (a)(3)(i) and 
(a)(3)(ii) of this section were completed or of April 28, 1999, whichever is later, the 
medical physicist shall have surveyed at least two mammography facilities and a total of 
at least six mammography units during the 24 months immediately preceding the date of 
the facilitys annual MQSA inspection or the last day of the calendar quarter preceding 
the inspection or any date in between the two.  The facility shall choose one of these dates 
to determine the 24-month period.  No more than one survey of a specific facility within a 
10-month period or a specific unit within a period of 60 days can be counted towards this 
requirement. 
  24  Question 11: I am qualified to perform screen-film surveys independently but also 
performed some FFDM surveys while under direct supervision.  Can I count those 
FFDM surveys toward my continuing experience requirement? 
Yes. 
The following questions and answers are being added to Personnel/Medical 
Physicist/Medical Physicist Initial Experience 
Citation: 
900.12(a)(3)(i)(B)(3):  Have the experience of conducting surveys of at least 1 
mammography facility and a total of at least 10 mammography units.  No more than one 
survey of a specific unit within a period of 60 days can be counted towards the total 
mammography unit survey requirement.  After April 28, 1999, experience conducting 
surveys must be acquired under the direct supervision of a medical physicist who meets 
all the requirements of paragraphs (a)(3)(i) and (a)(3)(iii) of this section. 
Question 8: I am a physicist who wishes to become initially qualified as a medical 
physicist. I completed my 20 contact hours of initial mammography training in 
screen-film mammography and performed one facility and ten unit surveys under 
direct supervision but all the surveys were performed in a full field digital 
mammographic facility.  Does this satisfy the regulatory requirement? 
Yes. While FDA recommends that personnel obtain initial experience using the same 
mammographic modality as used for the initial qualification, the regulations do not 
specifically require it.  Therefore, surveys performed for the initial experience 
requirement do not have to be in the same mammographic modality as surveys performed 
for the initial qualification.  
Question 9: I am the physicist in question 8.  Once Ive completed my initial 
requirements, can I independently perform both screen-film and FFDM surveys? 
No.  Because your initial training was only in screen-film, under MQSA you are qualified 
to perform only screen-film surveys independently.  In order to perform FFDM surveys, 
you will need to obtain and document eight hours of training in FFDM. 
900.12(a)(3)(iii)(C). 
Question 10: I am a physicist who wishes to become initially qualified as a medical 
physicist. I completed 10 contact hours of initial mammography training in screen-
film mammography and performed one facility and ten unit surveys under direct 
supervision. I wish to count the time spent performing these surveys toward the 20 
contact hour requirement.  All of the surveys were performed in a full field digital 
mammographic facility.  Is this acceptable and am I qualified to independently 
perform both screen-film and FFDM surveys? 
  25  Medical physicists (MP) may count the time they spent in the actual performance of 
surveys to be used toward satisfying the survey contact hour training requirement.  As 
guidance, however, FDA recommends that MPs not count more than four hours for each 
facility survey and two hours for each unit survey toward the required total hours of 
training.  Once an MP completes the facility and unit surveys, the MP is qualified to 
perform screen film surveys independently but not necessarily FFDM surveys.  In order 
for the MP to also perform FFDM surveys independently, the training program will have 
to supply the MP with additional documentation showing that at least eight hours of 
experience/training was in FFDM. 900.12(a)(3)(iii)(C). 
The following questions and answers are being added to Personnel/Medical 
Physicist/Medical Physicist New Mammographic Modality Training 
Citation: 
900.12(a)(3)(iii)(C): Before a medical physicist may begin independently performing 
mammographic surveys of a new mammographic modality, that is, a mammographic 
modality other than one for which the physicist received training to qualify under 
paragraph (a)(3)(i) or (a)(3)(ii) of this section, the physicist must receive at least 8 hours 
of training in surveying units of the new mammographic modality. 
Question 10: I am a physicist who wishes to become initially qualified as a medical 
physicist. I completed my 20 contact hours of initial mammography training in 
screen-film mammography and performed one facility and ten unit surveys under 
direct supervision but all the surveys were performed in a full field digital 
mammographic facility.  Does this satisfy the regulatory requirement? 
Yes. While FDA recommends that personnel obtain initial experience using the same 
mammographic modality as used for the initial qualification, the regulations do not 
specifically require it.  Therefore, surveys performed for the initial experience 
requirement do not have to be in the same mammographic modality as surveys used for 
the initial qualification.  
Question 11: I am the physicist in question 10.  Once Ive completed my initial 
requirements, can I independently perform both screen-film and FFDM surveys?  
No.  Because your initial training was only in screen-film, under MQSA you are qualified 
to perform only screen-film surveys independently.  In order to perform FFDM surveys, 
you will need to obtain and document eight hours of training in FFDM. 
900.12(a)(3)(iii)(C). 
Question 12: I am a physicist who wishes to become initially qualified as a medical 
physicist. I completed 10 contact hours of initial mammography training in screen-
film mammography and performed one facility and ten unit surveys under direct 
supervision. I wish to count the time spent performing these surveys toward the 20 
hour requirement.  All of the surveys were performed in a full field digital 
  26  mammographic facility.  Is this acceptable and am I qualified to independently 
perform both screen-film and FFDM surveys? 
Medical physicists (MP) may count the time they spent in the actual performance of 
surveys towards satisfying the survey contact hour training requirement.  As guidance, 
however, FDA recommends that MPs not count more than four hours for each facility 
survey and two hours for each unit survey toward the required total hours of training.  
Once an MP completes the facility and unit surveys, the MP is qualified to perform screen 
film surveys independently but not necessarily FFDM surveys.  In order for the MP to 
also perform FFDM surveys independently, the training program or trainer will have to 
supply the MP with additional documentation showing that at least eight hours of 
experience/training was in FFDM. 900.12(a)(3)(iii)(C). 
The following question and answer is being added to Personnel/Radiologic 
Technologist/Radiologic Technologist Continuing Experience 
Citation: 
900.12(a)(2)(iv)(A): Continuing experience requirements.  Following the second 
anniversary date of the end of the calendar quarter in which the requirements of 
paragraphs (a)(2)(i) and (a)(2)(ii) of this section were completed or of April 28, 1999, 
whichever is later, the radiologic technologist shall have performed a minimum of 200 
mammography examinations during the 24 months immediately preceding the date of the 
facilitys annual inspection or the last day of the calendar quarter preceding the 
inspection or any date in between the two.  The facility will choose one of these dates to 
determine the 24-month period. 
Question 11: I am qualified to perform screen-film mammograms independently but 
also performed some FFDM mammograms while under direct supervision.  Can I 
count those FFDM mammograms toward my continuing experience requirement? 
Yes. 
The following questions and answers are being added to Personnel/Radiologic 
Technologist/Radiologic Technologist Mammography Specific Training 
Citation: 
900.12(a)(2)(ii)(A)(B) and (C): Mammography requirements.  All mammographic 
examinations shall be performed by radiologic technologists who meet the following 
mammography requirements: Have, prior to April 28, 1999 qualified as a radiologic 
technologist under paragraph (a)(2) of this section of FDAs interim regulations of 
December 21, 1993, or completed at least 40 contact hours of documented training 
specific to mammography under the supervision of a qualified instructor.  The hours of 
documented training shall include, but not necessarily be limited to:   
  27  (A)  Training in breast anatomy and physiology, positioning and compression, quality 
assurance/quality control techniques, imaging of patients with breast implants;  
(B)  The performance of a minimum of 25 examinations under the direct supervision of 
an individual qualified under paragraph (a)(2) of this section; and  
(C)  At least 8 hours of training in each mammography modality to be used by the 
technologist in performing mammography exams. 
Question 14: I am a technologist who wishes to become initially qualified as a 
radiologic technologist. I completed my 40 hours of initial mammography training 
in screen-film mammography and performed 25 mammograms under direct 
supervision but all the examinations were performed on a full field digital 
mammographic (FFDM) unit.  Does this satisfy the regulatory requirement? 
Yes. While FDA recommends that personnel obtain initial experience using the same 
mammographic modality as used for the initial qualification, the regulations do not 
specifically require it.  Therefore, examinations performed for the initial experience 
requirement do not have to be in the same mammographic modality as examinations 
performed for the initial qualification.  
Question 15: I am the technologist in question 14.  Once Ive completed my initial 
requirements, can I independently perform both screen-film and FFDM 
examinations?  
No.  Because your initial training was only in screen-film, under MQSA you are qualified 
to perform only screen-film examinations independently.  In order to perform FFDM 
examinations, you will need to obtain and document eight hours of training in FFDM.  
900.12(a)(2)(iii)(E). 
Question 16: I am a technologist who wishes to become initially qualified as a 
radiologic technologist. I completed 27.5 hours of initial mammography training in 
screen-film mammography and performed 25 mammograms under direct 
supervision. I wish to count the time spent performing these mammograms toward 
the 40 hour requirement.  All of the examinations were performed on a full field 
digital mammographic unit.  Is this acceptable and am I qualified to independently 
perform both screen-film and FFDM examinations? 
In previously issued guidance, we stated that training programs or facilities may include 
the actual time spent performing supervised examinations toward the 40 hour total.  As 
guidance, however, FDA recommends that no more than 12.5 hours of the required 40 
come from performing examinations. Once you complete the 25 mammograms, you are 
qualified to perform screen film mammograms independently but not necessarily FFDM 
mammograms.  In order for you to also perform FFDM mammograms independently, the 
training program or mammography facility will have to supply you with additional 
documentation showing that at least eight hours of experience/training was in FFDM.  
900.12(a)(2)(iii)(E). 
  28  The following questions and answers are being added to Personnel/Radiologic 
Technologist/Radiologic Technologist New Mammographic Modality Training 
Citation: 
900.12(a)(2)(iii)(E): Before a radiologic technologist may begin independently 
performing mammographic examinations using a mammographic modality other than 
one of those for which the technologist received training under paragraph (a)(2)(ii)(C) of 
this section, the technologist shall have at least 8 hours of continuing education units in 
the new modality. 
Question 12: I am a technologist who wishes to become initially qualified as a 
radiologic technologist. I completed my 40 hours of initial mammography training 
in screen-film mammography and performed 25 mammograms under direct 
supervision but all the examinations were performed on a full field digital 
mammographic unit.  Does this satisfy the regulatory requirement? 
Yes. While FDA recommends that personnel obtain initial experience using the same 
mammographic modality as used for the initial qualification, the regulations do not 
specifically require it.  Therefore, examinations performed for the initial experience 
requirement do not have to be in the same mammographic modality as the examinations 
performed for the initial qualification.  
Question 13: I am the technologist in question 12.  Once Ive completed my initial 
requirements, can I independently perform both screen-film and FFDM 
examinations?  
No.  Because your initial training was only in screen-film, under MQSA you are qualified 
to perform only screen-film examinations independently.  In order to perform FFDM 
examinations, you will need to obtain and document eight hours of training in FFDM.  
900.12(a)(2)(iii)(E). 
Question 14: I am a technologist who wishes to become initially qualified as a 
radiologic technologist. I completed 27.5 hours of initial mammography training in 
screen-film mammography and performed 25 mammograms under direct 
supervision. I wish to count the time spent performing these mammograms toward 
the 40 hour requirement.  All of the examinations were performed on a full field 
digital mammographic unit.  Is this acceptable and am I qualified to independently 
perform both screen-film and FFDM examinations? 
In previously issued guidance, we stated that training programs or facilities may include 
the actual time spent performing supervised examinations toward the 40 hour total.  As 
guidance, however, FDA recommends that no more than 12.5 hours of the required 40 
come from performing examinations. Once you complete the 25 mammograms, you are 
qualified to perform screen film mammograms independently but not necessarily FFDM 
  29  mammograms.  In order for you to also perform FFDM mammograms independently, the 
training program or mammography facility will have to supply you with additional 
documentation showing that at least 8 hours of the 12.5 hours of experience/training was 
in FFDM. in order to demonstrate compliance with 900.12(a)(2)(iii)(E). 
The following is being added at the end of the discussion section of 
Personnel/Radiologic Technologist/Reestablishing the Radiologic Technologist 
Continuing Experience Requirement 
Citation: 
900.12(a)(2)(iv)(B) Requalification.  Radiologic technologists who fail to meet the 
continuing experience requirements of paragraph (a)(2)(iv)(A) of this section shall 
perform a minimum of 25 mammography examinations under the direct supervision of a 
qualified radiologic technologist, before resuming the performance of unsupervised 
mammography examinations. 
When a radiologic technologist (RT) fails to meet the continuing experience requirement 
of performing 200 mammograms in the previous 24 months, the RT must not perform 
mammograms independently until the RT re-qualifies. The RT can re-qualify by 
performing 25 mammograms under direct supervision. FDA considers the previous 24 
months to begin from the facility inspection date, or the date of the most recent calendar 
quarter preceding the inspection, or any date in between. 
When a facility is inspected within the 6-month period following the date the RT re-
qualified, FDA does NOT intend to cite the facility if the RT has not performed a total of 
200 mammograms in the previous 24 months. We consider this the 6-month exemption 
period. If the facility is inspected any time after the 6-month exemption period has 
expired (even 1 day after) and the RT has not performed a total of 200 mammograms in 
the previous 24 months, FDA DOES intend to cite the facility.  In summary, as long as 
the RT has performed at least 200 mammograms by the facility's next inspection, the RT 
is compliant with MQSA regulations. 
Example #1: An RT has been performing mammography for more than two years and is 
hired by a new facility on 9/3/2007. The RT has performed only 100 mammograms since 
9/1/2005. The RT performs 25 mammograms under direct supervision by 9/25/2007. The 
facility is inspected on 1/15/2008. At the time of the inspection, this RT has performed 
150 mammograms, which includes the 25 under supervision, since 9/1/2005. Should the 
facility be cited? 
No, because the RTs continuing experience requirement falls under the 6-month 
exemption period, which expires on 3/24/2008. 
Example #2: This same facility is inspected on 4/15/2008 and the RT has performed 175 
mammograms, which includes the 25 under supervision, since 4/1/2006. Should the 
facility be cited? 
  30  Yes, because the 6-month exemption period after requalification has passed and the RT 
has not performed the required 200 mammograms. 
Example #3: This same facility is inspected on 4/15/2008 and the RT has performed 200 
mammograms, which includes the 25 under direct supervision, since 4/1/2006, but the RT 
had performed only 175 mammograms by 3/31/08 (a date after the 6-month exemption 
period). Should the facility be cited? 
No, because the RT has performed the required 200 mammograms by the date of the 
inspection. 
The following questions and answers are being added to Quality 
Assurance/Equipment/Air Kerma Calibration 
Citation: 
900.12(e)(12):  Calibration of air kerma measuring instruments. Instruments used by 
medical physicists in their annual survey to measure the air kerma or air kerma rate from 
a mammography unit shall be calibrated at least once every 2 years and each time the 
instrument is repaired.  The instrument calibration must be traceable to a national 
standard and calibrated with an accuracy of 6 percent (95 percent confidence level) in 
the mammography energy range.  
Question 4: Must my air kerma measuring instrument be calibrated to all the target 
filter combinations I encounter during surveys and MEEs?  Also, how does this 
calibration requirement affect kVp and dose measurements? 
While the above regulation requires that all air kerma measuring instruments be 
calibrated to a standard that is traceable to the National Institute of Standards and 
Technology (NIST), the regulation does not specify the target filter combination to be 
used.  Currently, all air kerma measuring instruments are typically calibrated in the 
mammography kVp range using only one target filter combination, such as 
molybdenum/molybdenum (Mo/Mo), even if the instrument is used with other 
combinations such as tungsten/silver (W/Ag) or tungsten/rhodium (W/Rh).  In addition, 
NIST currently does not have the ability to provide calibration standards for W/Ag or 
W/Rh target filter combinations in the mammography kVp range.  Consequently, while 
FDA continues to require that all air kerma measuring instruments be calibrated to a 
NIST-traceable standard for at least one target filter combination in the mammography x-
ray range, FDA does not intend to enforce such calibration requirement with respect to 
W/Ag or W/Rh beams. 
It is well known that the energy response for ionization chamber-based air kerma 
measuring instruments is typically flat in the 20-40 kVp range.  For solid-state air kerma 
measuring instruments however, the energy response is not flat and because of this, the 
air kerma readings from these instruments may need to be adjusted by an appropriate 
  31  correction factor.  The correction may already be handled internally by the instrument or 
you may need to contact the instrument manufacturer for the correction factor.  
Question 5: Most non-invasive kVp meters are only calibrated for Mo/Mo and 
Mo/Rh beams and therefore give inaccurate kVp readings when used with FFDM 
units that only have W/Ag or W/Rh target/filter combinations.  How should I 
compensate for this error when doing surveys and MEEs on such units? 
The kVp value needs to be measured under one target/filter combination for which the 
kVp meter is calibrated (e.g., Mo/Mo, Mo/Rh, etc.).  However, if the mammography unit 
has only a W/Ag or W/Rh target/filter combination, the measurement results must be 
appropriately corrected. FDA believes that the issue of inaccurate non-invasive kVp 
measuring instruments is one that ultimately is best resolved by the kVp instrument 
manufacturers and the medical physicists.  Until this matter is resolved, FDA has the 
following suggestions for the equipment scenarios listed below: 
kVp Measurements 
Scenario 1.  If you are using a kVp meter that has been manufacturer-certified for W/Ag 
and W/Rh beams and a mammography-calibrated ion chamber, you may accept the 
measurement results and record them in the medical physicist survey or mammography 
equipment evaluation (MEE).   
Scenario 2.  If your kVp meter has not been manufacturer-certified for W/Ag and W/Rh 
beams and you are using a mammography-calibrated ion chamber, you should include a 
correction factor in your kVp measurements.  This correction factor may be obtained 
from the kVp meter manufacturer, or by working with the mammography units service 
engineer (by comparing the engineers manufacturer-approved measurements during 
machine installation with your non-invasive meter results).  You may also use this 
correction factor when performing MEEs or surveys using this kVp meter/ion chamber 
combination on other FFDM units by the same manufacturer that also have W/Ag or 
W/Rh target filter combinations. 
Scenario 3. If your kVp meter has not been manufacturer-certified for W/Ag and W/Rh 
beams and you are using a separate solid-state probe, then you should follow Scenario 2 
for kVp Measurements. 
The table below gives a summary of the action needed under each of the three Scenarios 
discussed above. 
kVp Measurement of W/Ag and W/Rh Beams 
Scenario  kVp Meter  Air Kerma  Action  Correction Factor 
Instrument 
1  Certified by  Ion chamber  Accept  N/A 
manufacturer  calibrated for  measurement 
  32  for W/Ag and  mammography 
W/Rh 
2  Not certified by  Ion chamber  Apply  Obtain from kVp meter 
manufacturer  calibrated for  correction  manufacturer or develop 
for W/Ag and  mammography  factor to kVp  by comparing engineers 
W/Rh  measurements  manufacturer-approved 
measurements during 
machine installation 
with your kVp meter 
3  Not certified by  Solid state  Apply  Obtain from kVp meter 
manufacturer  probe  correction  manufacturer or develop 
for W/Ag and  factor to kVp  by comparing engineers 
W/Rh  measurements  manufacturer-approved 
measurements during 
machine installation 
with your kVp meter 
 
HVL Assessments   
Scenario 1.  If you are using an integrated solid state instrument (one that automatically 
measures kVp, HVL, and dose) and the instrument is manufacturer-certified for W/Ag 
and W/Rh, you may accept the measurement results and record them in the medical 
physicist survey or MEE.    
Scenario 2.  If you are using an integrated solid state instrument that is not manufacturer-
certified for W/Ag or W/Rh, you should determine the HVL using exposure 
measurements in the standard manner.  You may then use this HVL value with the 
appropriate dose conversion table that is provided in the FFDM manufacturers QC 
manual to estimate the dose. Determine from the manufacturer of the dosimetry device if 
the exposure readings need to be corrected as aluminum is added to the beam. If so, then 
apply the correction factors applicable to each reading. It may be necessary to determine a 
typical correction factor by intercomparison with a mammography-calibrated ion 
chamber; this factor may then be used in the future.  If the estimated dose is above 2.7 
milligray (270 mrad), you should determine the actual HVL with a mammography-
calibrated ion chamber and then use the actual HVL value to estimate the dose using the 
same conversion table provided in the QC manual. 
Scenario 3. If your kVp meter has not been manufacturer-certified for W/Ag and W/Rh 
beams and you are using a separate solid-state probe, you should follow Scenario 2 for 
HVL Assessments. 
The table below gives a summary of the action needed under each of the three scenarios 
discussed above. 
  33  HVL Assessments of W/Ag and W/Rh Beams 
Scenario  kVp Meter  Air Kerma  Action  Correction Factor 
Instrument 
1  Integrated solid state instrument  Accept measurement  N/A 
(measuring kVp, HVL, and dose) 
certified by manufacturer for 
W/Ag and W/Rh 
2  Integrated solid state instrument   Apply correction  Obtain from kVp 
(measuring kVp, HVL, and dose)  factor to exposure  meter 
NOT certified by manufacturer   Calculate HVL in  manufacturer or 
for W/Ag and W/Rh  standard manner  develop by 
 Use corrected kVp  comparing 
with estimated HVL  engineers 
from dose table (in  manufacturer-
FFDM manufacturers  approved 
QC manual) to see  measurements 
estimated dose (see  during machine 
scenario 2 for more  installation with 
info)  your kVp meter 
3  Not certified by  Separate solid   Apply correction  Obtain from kVp 
manufacturer  state probe  factor to exposure  meter 
for W/Ag and   Calculate HVL in  manufacturer or 
W/Rh  standard manner  develop by 
Use corrected kVp with  comparing 
estimated HVL from  engineers 
dose table (in FFDM  manufacturer-
manufacturers QC  approved 
manual) to see  measurements 
estimated dose (see  during machine 
scenario 2 for more  installation with 
info)  your kVp meter 
 
Modification to the table in Quality Assurance/Equipment/Annual Physics Survey, 
Quality Assurance/Equipment/Mammography Equipment Evaluations, and Quality 
Assurance/Equipment/Use of Test Results 
Table: Medical Physicist Involvement in Equipment Adjustments, Changes, or Repairs 
For any adjustment, change, or repair not listed in the table below, or if the facility is 
unsure as to whether the full extent of the adjustment, change, or repair qualifies as a 
major repair, the facility should consult its their medical physicist to determine the proper 
extent of his or her involvement in evaluating the item. 
Major 
Item  Medical Physicist Involvement 
Repair 
  34  Automatic Exposure Control 
AEC replacement  Y 
MP conducts evaluation in person 
Thickness compensation internal*  N 
MP oversight 
adjustment 
AEC sensor replacement  Y 
MP conducts evaluation in person  
AEC circuit board replacement  Y 
MP conducts evaluation in person 
Density control  internal*  N 
MP oversight 
adjustment 
Bucky (New to Facility) Replacement 
AEC sensor also replaced  Y 
MP conducts evaluation in person 
AEC sensor not replaced  N 
MP oversight 
FFDM detector also replaced  Y 
MP conducts evaluation in person 
FFDM detector not replaced  N 
MP oversight 
Cassette Replacement 
Same screen speed  N 
MP involvement optional oversight 
Faster screen speed  N 
MP oversight 
Slower screen speed where  Y 
MP conducts evaluation in person 
the dose increase may 
exceed 3.0 mGy for 
the standard breast 
Collimator 
Replacement  Y 
MP conducts evaluation in person 
Reassembly with blade  Y 
MP conducts evaluation in person 
replacement 
Adjustment  N 
MP oversight 
Compression Device  
Pressure adjustment  N 
MP involvement optional 
Thickness scale accuracy  N 
MP oversight 
adjustment but only if it 
affects AEC 
performance 
Repair of auto decompression  N 
MP involvement optional 
Compression Paddle  
Paddle (new to facility)  N 
MP oversight 
replacement 
Deflection adjustment  N 
MP oversight 
Adjustment due to extension  N 
MP oversight 
beyond allowable limit, 
or visibility on images 
Darkroom 
Repair of light leaks  N 
MP involvement optional 
  35  Safe light change  N 
MP involvement optional 
N 
Film Type/Speed Change  MP oversight 
Processor 
Chemistry type change  N 
MP involvement optional 
Fixer/Developer replacement  N 
MP involvement optional 
Installation  Y 
MP conducts evaluation in person 
Reassembly  Y 
MP conducts evaluation in person 
Replenishment rate adjustment  N 
MP involvement optional 
Roller replacement  N 
MP involvement optional 
X-ray Unit  
kVp, mA or time internal*  N 
MP oversight 
adjustments 
High voltage generator  Y 
MP conducts evaluation in person 
replacement 
X-ray tube replacement  Y 
MP conducts evaluation in person 
Filter replacement  Y 
MP conducts evaluation in person 
Installation  Y 
MP conducts evaluation in person 
Reassembly  Y 
MP conducts evaluation in person 
Manufacturer's software  Y 
MP conducts evaluation in person 
modifications (see approved 
alternative standard) 
FFDM detector replacement or  Y 
MP conducts evaluation in person 
repair 
FFDM Display (monitor)/Printer   Check FFDM 
Follow FFDM manufacturers QC 
Replacement  manufacturers QC 
manual 
manual 
 
* Internal adjustments refer to equipment adjustments that typically cannot be made by 
the operator 
 
The following question and answer is being modified: Question 2 in Quality 
Assurance/Equipment/Dosimetry  Annual Quality Control Test and Question 18 in  
Quality Assurance/Equipment/Phantom Image  Weekly Equipment Quality 
Control Tests 
 
Questions 2 and 18: We are using an FDA cleared single-use cushion pad when 
performing mammograms on some of our patients. Do we have to include the pad 
when performing the phantom and dose QC tests? 
 
When performing the weekly and annual phantom and dose tests, you must simulate as 
closely as possibly your typical clinical conditions.  21 CFR 900.12(e)(2)(i), (e)(5)(vi).  
Thus, iIf you are not using a cushion pad for more than half the majority of your patients, 
  36  you do not have to include the cushion pads when performing the phantom and dose QC 
tests. 
However, if you are using a cushion pad for more than half the majority of your screen-
film patients, you must include the cushion pads when performing these weekly phantom 
and annual phantom and dose QC tests in order to simulate as closely as possible your 
typical clinical conditions (21 CFR 900.12(e)(2)). If you routinely use the cushion pad on 
both the bucky and the compression paddle, you must use 2 two layers of the cushion pad 
when performing the phantom and dose QC tests. While not a regulatory requirement, 
FDA recommends that the pads also be included when performing AEC testing. When 
used clinically, the cushion pad is a single use device. Because of this, QC testing with 
the cushion pad in place is most appropriate when performing the phantom and dose tests. 
Therefore the facility does not have to include the cushion pad when performing other QC 
tests. 
For FFDM units, we recommend that you perform QC tests, such as the phantom test, 
under clinical conditions. However, we can only REQUIRE that a facility include the pad 
during the test(s) when the manufacturers QC manual specifies a pad be present during 
QC testing. The unit manufacturers QC manual defines the test conditions for the 
phantom image and other QC tests because, under 21 CFR 900.12(e)(6), ...the quality 
assurance program shall be substantially the same as the quality assurance program 
recommended by the image receptor manufacturer.  
The following question and answer is being added to Quality Assurance/Equipment/ 
Compression Device Performance - Semiannual Quality Control Tests 
Citation: 
900.12(e)(4)(iii)(A)(B):  Semiannual quality control tests.   Facilities with screen-film 
systems shall perform the following quality control tests at least semiannually: 
 (iii)  Compression device performance. 
(A)  A compression force of at least 111 newtons (25 pounds) shall be provided. 
(B)  Effective October 28, 2002, the maximum compression force for the initial power 
drive shall be between 111 newtons (25 pounds) and 200 newtons (45 pounds). 
Question 3: Is tapping the foot control of the initial power drive compression device 
more than once acceptable when testing initial power drive performance in 
computer-controlled compression devices? 
The initial power drive on some mammography units (e.g., Siemens Mammomat) is 
designed with a built-in sensor that terminates the pressure applied to the paddle once the 
systems software algorithm determines that additional force will not achieve further 
thickness reduction. 
This design is intended to maximize patient comfort while achieving optimum 
compression. When such a device is pressed against a hard surface (such as a bathroom 
scale), the sensor, recognizing that very little or no compression has been achieved by the 
  37  applied force up to that point, terminates the pressure before the maximum force can be 
achieved. When performing the compression test with such a device, the person 
conducting the test (i.e., radiologic technologist or medical physicist) may have to press 
the foot pedal more than once to accurately measure the maximum force. 
Failure to do so may lead the person conducting the test to report an artificially low 
maximum compression force. This could lead to an inappropriate failure of the initial 
power drive compression device quality control test. 
The following questions and answers are being added to Quality 
Assurance/Equipment/ Other Modalities Quality Control Tests 
Citation: 
900.12(e)(6):  Quality Control tests  other modalities.  For systems with image receptor 
modalities other than screen-film, the quality assurance program shall be substantially 
the same as the quality assurance program recommended by the image receptor 
manufacturer, except that the maximum allowable dose shall not exceed the maximum 
allowable dose for screen-film systems in paragraph (e)(5)(vi) of this section.  
Question 5: As a medical physicist is there anything I need to be aware of regarding 
laser printer mammography equipment evaluations (MEE)? 
Some medical physicists are not including appropriate testing of the laser printer in their 
survey/MEE reports to the facility.  There seems to be confusion about the required MEE 
testing of a laser printer:  (1) before it is first put into clinical use; (2) following 
reassembly; or (3) after major repairs vs. the routine quality control QC testing of the 
laser printer after it is placed into clinical use.  In some cases, the medical physicists did 
not test the laser printer at all, did inappropriate testing, or did appropriate testing but did 
not include documentation of the tests in the facility survey/MEE report.  Therefore, FDA 
is clarifying the applicable MQSA requirements.  
The regulations at 21 CFR 900.12(e)(6) require that all test procedures be conducted as 
specified in the QC manual of the FFDM system manufacturer.  Some of these QC 
manuals specify both periodic QC (daily, weekly, or annual) and MEE testing for the 
laser printer while others do not address the subject and refer the user to the laser printer 
manufacturers QC manual.   
A table summarizing the laser printer test procedures in the current FFDM manufacturer 
QC manuals is available on the following webpage: 
http://www.fda.gov/Radiation-
EmittingProducts/MammographyQualityStandardsActandProgram/Guidance/ucm219622.
htm  
  38  Some of FFDM QC manuals do not specifically address the laser printer MEE testing 
requirements when first installed, reassembled, or after having undergone a major repair. 
They instead instruct operators to follow the applicable printer QC manual.  Hence, the facility 
or medical physicist has to obtain this information from the laser printer manufacturer.  In 
some cases, the QC manuals only address the interface between the FFDM unit and the 
laser printer.  They do not address the basic requirement that the laser printer, before it is 
used clinically for mammography, has to be operating as designed by the laser printer 
manufacturer.  Because the MEE requires that both the interface and basic requirements 
be checked, the medical physicist may have to consult both the FFDM manufacturers QC 
manual and the laser printer QC or operators manual to determine which tests are 
required to assure that the laser printer is functioning properly before being used 
clinically.  
Some medical physicists incorrectly assume that simply scoring a laser printed phantom 
image satisfies all the requirements of the laser printer MEE.  However, in most cases, 
simply scoring a phantom would be unacceptable under the applicable manual(s).  To 
avoid unnecessary follow-ups by MQSA inspectors or facility citations, we urge all 
medical physicists to review the FFDM manufacturers QC manual and, where necessary, 
the laser printer QC or operators manual to determine the appropriate testing.  Medical 
physicists must clearly document the testing of the laser printer in their reports. 
Question 6: We do not have a QC manual for our printers or monitors.  What QC 
testing should we perform on our printers and monitors? 
Under 21 CFR 900.12(e)(6), facilities using a mammographic modality other than screen-
film must follow a quality control program that is substantially the same as the quality 
assurance program recommended by the image receptor manufacturer. While all FFDM 
manufacturers have QC manuals, in some cases, the QC manual instructs the facility to 
test monitors and printers according to the components QC manual. In these cases, it is 
the responsibility of each facility to ensure that it obtains and follows the components 
QC manual for its monitors and printers.  
Question 7: We have FFDM units from different manufacturers, each with its own 
QC manual.  The manuals have different recommendations for QC testing of our 
printers and monitors.  What QC testing should we perform on our printers and 
monitors? 
For facilities that are using FFDM units from different manufacturers, each with its own 
QC requirements for printers and monitors, there may be uncertainty regarding which QC 
tests must be performed on these components. The following three examples should help 
facilities decide.  
  a. Each FFDM manufacturers QC manual requires that the same test be done, but 
at different time frequencies. In this case facilities should perform the test at the 
more stringent frequency.  
  39    b. Each FFDM manufacturers QC manual requires that different but equivalent 
tests be done. In this case facilities may perform only one of the tests at the more 
stringent frequency. The medical physicist should provide a written statement for 
the facilitys quality control records, indicating that, in his or her opinion, the two 
tests are equivalent.  
  c. Each FFDM manufacturers QC manual requires that different tests (not 
equivalent) be done. In this case facilities should perform each test at the 
frequency required in the respective FFDM manufacturers QC manual.  
Question 8: An FFDM unit is located in a satellite facility of a main hospital, and the 
review work station (RWS) and hard copy printer are located at the main hospital. 
The FFDM manufacturer quality control manual instructions call for making a 
final decision on whether the phantom image test passes by scoring the image either 
from the RWS or from a printed image. How can the inspector score the image 
correctly if the RWS and printer are not onsite during the inspection? 
 
What follows is the recommended procedure for the inspector.  The inspector: 
  1. asks the technologist to expose the phantom and produce an image.  The inspector 
scores the phantom image on the acquisition work station (AWS) and, if the image 
passes, enters the information into the inspection software and closes out the 
inspection. If the image does not pass, the inspector:  
  2. asks the technologist to expose the phantom a second time to produce another 
image.  The inspector scores this second phantom image on the AWS and if the image 
passes, closes out the inspection as in step #1 above. If the image does not pass, the 
inspector asks the satellite facility to send both phantom images to the hospital. 
Hospital personnel are instructed to print a hardcopy of both images and mail the 
images to the inspector. The inspector scores the images. This process should be 
accomplished within 5 days. The completed inspection is then downloaded to the 
FDA and a summary report is sent to the facility.  
Question 9: What testing do the various FFDM manufacturers require for a new 
unit mammography equipment evaluation (MEE)? 
A table summarizing FFDM manufacturers testing requirements for new unit 
mammography equipment evaluations is available on the following webpage: 
http://www.fda.gov/Radiation-
EmittingProducts/MammographyQualityStandardsActandProgram/FacilityCertificationan
dInspection/ucm114138.htm  
Question 10: Is there a list that shows the laser printers that have been cleared for 
mammography by the FDA?  If not, how can I determine if FDA has cleared a given 
laser printer for mammography use? 
No.  Although FDA has cleared many printers for FFDM use through the 510(k) process, 
FDA does not keep a list of cleared printers, other than what is available in FDAs 510(k) 
  40  database at http://www.fda.gov/cdrh/510khome.html#database.  You can search this 
database by product code, device name, applicant name, decision date, and other 
elements, including a simple word search.  Another way to find out whether a particular 
printer has been cleared for FFDM use is to check the devices labeling or to have 
the printer manufacturer provide you with written documentation showing that the printer 
has been cleared by FDA for FFDM. 
Question 11: We are an FFDM certified facility but have now decided to have our 
mammography examinations read off-site at another already certified facility.  This 
process entails the use of a review workstation and laser printer (accessory 
components) that are new to our facility.  We know that we have to perform a 
Mammography Equipment Evaluation (MEE) on these accessory components prior 
to clinical use.  However, since the accessory components have already undergone 
an MEE and are currently being used at the other facility, do they have to undergo 
a new MEE or can we use their original MEE or a subsequent annual physics 
survey instead? 
For MEE tests that are specific to the accessory component, such as the SMPTE pattern, 
monitor luminance, and room illumination for the review workstation, the SMPTE 
pattern for the laser printer, and other component-specific tests that may be listed in the 
components QC manual, you can use the test results from previous annual physics 
surveys or MEEs as long as those tests were performed within the last 14 months.  For 
those MEE tests that evaluate the performance of the whole imaging chain and help to 
ensure that all the system components are compatible with one another, such as the 
phantom image and other tests that may be listed in the FFDM manufacturers or 
accessory components QC manual, FDA interprets 21 CFR 900.12(e)(10) to mean that 
you cannot use prior tests.  The medical physicist must perform these MEE tests on the 
accessory components prior to using the components in patient examinations. 
Question 12: We are adding an FFDM unit to our already certified digital facility.  
We know that we have to perform an MEE on the unit prior to clinical use.  
However, since our review workstation and laser printer (accessory components) 
have already undergone an MEE and are currently being used with our first unit, 
do they have to undergo a new MEE or can we use their original MEE or a 
subsequent annual physics survey instead? 
Same answer as in Question 11. 
Question 13: We are applying to become a new FFDM certified facility.  We know 
that we have to perform an MEE on the unit prior to clinical use.  However, we will 
have our examinations read off-site using a review workstation and laser printer 
(accessory components) that are currently located at another certified facility.  
Those accessory components have already undergone an MEE as part of the other 
  41  facility.  Do these accessory components have to undergo a new MEE or can we use 
their original MEE or a subsequent annual physics survey instead? 
Same answer as in Question 11. 
Question 14: Our facility has five FFDM units (not all of the same model or from the 
same manufacturer), two laser printers (not the same model or from the same 
manufacturer) and four review workstations (not all of the same model or from the 
same manufacturer).  We run clinical images through all the accessory components 
interchangeably.  Do we have to perform periodic QC testing (e.g., weekly phantom 
image test) on all possible combinations of units with the printers and review 
workstations? 
If the facilitys medical physicist provides the facility with documentation that the FFDM 
units and accessory components are matched (see below), then the facility may perform 
its periodic QC tests using any review workstation or laser printer, as long as each 
accessory component is tested at its recommended frequency.  For example, if the QC 
manual specifies performing the phantom image test on a weekly basis, the facility may 
produce a phantom image using each of its x-ray units and evaluate them on any review 
workstation or laser printer at least once each week of use.  One mechanism by which the 
medical physicist can consider the FFDM units and the accessory components to be 
matched is for the medical physicist to initially perform and obtain passing results for all 
applicable QC tests through all possible combinations.  (In this scenario each accessory 
component must be operating within its own pre-established action limits set forth in the 
applicable QC manual.) 21 CFR 900.12(e)(6).  This method will reduce the number of 
QC tests that must be performed.  Note:  At least one example of each required QC test 
must be evaluated using each accessory component at the required periodic frequency.  21 
CFR 900.12(e)(6). 
Question 15: We have a screen-film unit that we are converting to FFDM-computed 
radiography (CR) use.  We know that we have to perform a Mammography 
Equipment Evaluation (MEE) on the CR system prior to clinical use.  However, 
since the unit underwent an MEE when it was first installed and has had 
subsequent testing as part of the annual physics survey does it have to undergo a 
new MEE or can we use its original MEE or a subsequent annual physics survey 
instead? 
For those tests that are unit specific and independent of the computed radiography (CR) 
system, FDA interprets 21 CFR 900.12(e)(10) to mean that you may use the test results 
from previous annual physics surveys or MEEs as long as the tests were performed within 
the last six months.  For those MEE tests that evaluate the performance of the whole 
imaging chain and help to ensure that all the system components are compatible, such as 
the phantom image, and other tests that may be listed in the CR manufacturers QC 
manual, FDA interprets 21 CFR 900.12(e)(10) to mean that you cannot use prior tests.  
  42  The medical physicist must perform these MEE tests on the accessory components prior 
to using the components in patient examinations. 
  43