Guidance for Industry and FDA 
Staff  
Mammography Facility Surveys, 
Mammography Equipment 
Evaluations, and Medical Physicist 
Qualification Requirements under 
MQSA 
Document issued on: September 13, 2005
This document supersedes the Mammography Facility Survey, Equipment 
Evaluation, and Medical Physicist Qualification Requirements under MQSA 
document issued on November 6, 2000 
For questions regarding this document contact Kish Chakrabarti, Kish.Chakrabarti@fda.hhs.gov and 301-
796-6539
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Office of In Vitro & Radiological Health 
Division of Mammography Quality Standards 
Program Management Branch  Contains Nonbinding Recommendations 
 
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.  When submitting comments, please refer to the exact title of 
this guidance document.  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/cdrh/mammography, or 
to receive this document by fax, call the CDRH Facts-On-Demand system at 800-899-0381 or 
301-827-0111 from a touch-tone telephone.  Press 1 to enter the system.  At the second voice 
prompt, press 1 to order a document.  Enter the document number 6409 followed by the pound 
sign (#).  Follow the remaining voice prompts to complete your request.   
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Table of Contents 
Introduction ..................................................................................................................................... 4 
The Least Burdensome Approach ................................................................................................... 5 
Background ..................................................................................................................................... 5 
MQSA Requirements for the Mammography Facility Survey (see Attachments A and B) ........... 6 
Scope of the MEE ......................................................................................................................... 13 
MQSA Medical Physicists Qualification Requirements (see Attachment C) ............................... 15 
Additional Guidance ..................................................................................................................... 18 
Alternative Initial Qualification .................................................................................................... 18 
Inspection Questions Related to the Physicists Qualifications .................................................... 24 
Requirement for the Medical Physicists Survey and Mammography Equipment Evaluations ... 26 
QC Tests - Annual ........................................................................................................................ 27 
MQSA Personnel Requirements For Medical Physicists ............................................................. 31 
ATTESTATION FORM ............................................................................................................... 33 
 
  3  Contains Nonbinding Recommendations 
 
Guidance for Industry and FDA Staff  
Mammography Facility Surveys, 
Mammography Equipment Evaluations, and 
Medical Physicist Qualification 
Requirements under MQSA
 
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, medical physicists, 
and FDA staff.  It represents the Food and Drug Administrations (FDA) current thinking on the 
final regulations implementing the Mammography Quality Standards Act (MQSA) (Public Law 
102-539).    This document revises the previous guidance document of the same title issued on 
November 6, 2000 and addresses: 
1.  The elements that make up the annual physics survey, 
2.  The elements that make up the mammography equipment evaluation, and 
3.  Medical physicist qualification requirements. 
The regulations covering these three areas are included as Attachments A, B, and C for the 
convenience of the reader.  Most of the citations referenced in this document may be found in 
one of those three attachments. 
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. 
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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. 
The Least Burdensome Approach 
We believe we should consider the least burdensome approach in all areas of medical device 
regulation.  This guidance reflects our careful review of the relevant scientific and legal 
requirements and what we believe is the least burdensome way for you to comply with those 
requirements.  However, if you believe that an alternative approach would be less burdensome, 
please contact us so we can consider your point of view.  You may send your written comments to 
the contact person listed in the preface to this guidance or to the CDRH Ombudsman.  
Comprehensive information on CDRH's Ombudsman, including ways to contact him, can be 
found on the Internet at http://www.fda.gov/cdrh/ombudsman/.  
Background 
MQSA was signed into law on October 27, 1992, to establish national quality standards for 
mammography.  The MQSA required that to provide mammography services legally 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 body.  The authority to approve 
accreditation bodies, State certification bodies, and to certify facilities was delegated by the 
Secretary to the FDA.  On October 28, 1997, the FDA published the MQSA final regulations in 
the Federal Register.  The FDA compiled all final guidance related to MQSA into a 
computerized searchable Policy Guidance Help System (PGHS) in November 1998.  The PGHS 
is available on the Internet at: www.fda.gov/cdrh/mammography/robohelp/start.htm 
This guidance document serves to update the PGHS and previous guidance document of the 
same title issued on November 6, 2000.  Guidance information is periodically updated.  
Individuals wishing to get automatic notification of such updates may subscribe to our E-mail 
ListServ by visiting http://list.nih.gov/cgi-bin/wa?SUBED1=mammography_cdrh-l&A=1 and 
follow the directions there. 
On October 28, 1997, the Food and Drug Administration (FDA) published the final regulations 
under the MQSA.  These regulations require each certified mammography facility to utilize the 
services of a qualified medical physicist to survey the facilitys equipment and to oversee the 
equipment-related quality control (QC) program used by the facility (21 CFR 900.12(d),(e); see 
Attachment A).  The facility is also required to have any equipment that is new to the facility, has 
been reassembled, or has undergone any major repair (including component replacement) 
evaluated by a medical physicist (21 CFR 900.12(e)(10); see Attachment A).  
These regulations, and MQSA itself, require that each certified facility undergo an annual on-site 
physics consultation and evaluation survey performed by a qualified medical physicist.  The 
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physicists survey must include several specific items and the physicist must provide the facility 
with a report outlining the testing and results of the survey (21 CFR 900.12(e)(9)). 
The regulations also require that a medical physicist perform mammography equipment 
evaluations (MEE) on x-ray units and film processors, whenever such evaluations are necessary 
(21 CFR 900.12(e)(10)).  This guidance includes a brief discussion of the requirements and scope 
of the survey and the MEE are included. 
Before a medical physicist can independently conduct either the annual survey or the MEE, he or 
she must meet the initial and continuing education and experience requirements under the final 
regulations (21 CFR 900.12(a)(3)).  This guidance reviews these requirements in the section 
dedicated to the physicist qualifications. 
For more detailed information, please refer to the PGHS on the MQSA Internet site, 
http://www.fda.gov/cdrh/mammography/ 
MQSA Requirements for the Mammography Facility 
Survey (see Attachments A and B) 
This section reviews the following: 
  The completion and the content of the annual survey report, and  
  Items the MQSA inspectors routinely look for when reviewing the annual survey report 
during inspections. 
Frequency of the Survey 
The medical physicists survey must be performed at least annually (21 CFR 900.12(d)(1)(iii) in 
Attachment A). MQSA inspectors are instructed that the facility meets this requirement if, at the 
time of the inspection, the most recent survey was conducted within 14 months of the previous 
survey and within 14 months of the current inspection.  FDA selected this approach to provide 
facilities and physicists some flexibility in scheduling the surveys.  
What a Complete Survey Must Include 
The medical physicist is responsible for performing the facilitys annual survey and sending the 
survey report to the facility within 30 days after conducting the survey.   
The regulations (21 CFR 900.12(e)(9)) contain a listing of the required testing and evaluation.  
The medical physicist performing or supervising the survey must date and sign the survey report, 
and identify other individual(s) who participated in the survey under the direct supervision of the 
medical physicist.  If the survey is done over a period of time, the physicist must indicate in the 
report the dates of completion of the individual parts.  While a report may contain both the 
survey and report dates, the survey date(s) must (21 CFR 900.12(e)(9)(v)) be clearly identified.  
As discussed above, the physicist must perform the survey at least annually, and no part of the 
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survey can be more than 14 months old at the time of the inspection or more than 14 months 
from the date it was conducted during the previous survey. 
The survey must contain the following (21 CFR 900.12(e)(5) in Attachment B): 
1.  All testing specified in the list of the annual QC tests: 
  Automatic exposure control (AEC) performance, 
  Kilovoltage peak (kVp) accuracy and reproducibility, 
  System resolution test, 
  Half-value layer (HVL) test, 
  Coefficient of variation (COV) for the breast entrance air kerma, 
  COV for the AEC reproducibility, 
  Average glandular dose calculation, 
  X-ray/light-field (where applicable)/image receptor alignment and image receptor 
/compression paddle alignment, 
  Screen speed uniformity, 
  System artifacts, 
  Radiation output, 
  Decompression (compression release), 
The quality assurance program for non screen-film units (such as full field digital 
mammography (FFDM) systems) must be substantially the same as the one specified by the 
image receptor manufacturer. 
2.  The phantom image quality test described under the weekly quality control requirements (the 
physicist must perform the phantom image test for each unit evaluated during the survey) (21 
CFR 900.12(e)(9) in Attachment A). 
3.  An evaluation of the facility quality control testing performed since the last survey and any 
written documentation regarding corrective actions taken, including the results of any such 
corrective actions. 
The survey report must contain the following: 
  A summary of the annual test results listed above, which should include pass/fail 
designations and numerical results, where applicable, 
  A summary of the evaluation of the facility QC testing (other than annual) with any 
recommendations for necessary improvements and/or corrective actions, as needed, 
  The date of the survey, 
  The name(s) of the medical physicist performing or supervising the survey, as well as any 
other individual(s) participating in the survey under the direct supervision of the medical 
physicist. 
The survey report must (21 CFR 900.12(e)(9)(iii)) contain sufficient information to document 
that each test was conducted according to the requirements.  For example, when reporting the 
dose calculations, the report should contain information regarding the phantom used and the kVp 
at which the HVL and the dose were obtained.  If such information is not included, then copies of 
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the data collected during the survey showing all measurement parameters should be provided 
along with the report. 
Table 1 lists the required testing that must be addressed in the survey.  Each item is listed by its 
common name and the subpart of 21 CFR 900.12(e) where the requirement is listed. This table is 
adapted from one included in the The Mammography Quality Standards Act Policy Guidance 
Help System (PGHS), referenced above. 
Timeliness of the Survey Report 
The physicists survey report must be sent to the facility within 30 days of the survey (21 CFR 
900.12(e)(9)(iv) in Attachment A).  However, it is imperative that the medical physicist notifies 
the facility immediately of any test failures or problems.  Failures or problems concerning QC 
tests referenced in 21 CFR 900.12(e)(8)(ii)(B) must be corrected within 30 days of the test date.  
However, facilities are required to correct all problems in the tests listed below (see 21 CFR 
900.12(e)(8)(ii)(A)) before any further examinations are performed or any films are processed 
using the component of the mammography system that failed the test.... 
  Daily QC tests (e)(1), 
-  Base plus fog 
-  Mid-density 
-  Density difference 
  Weekly QC tests (e)(2), 
-  Phantom image quality (also performed as a part of the physicist survey) 
  Semiannual QC tests (e)(4) 
-  Darkroom fog (e)(4)(i), 
-  Screen-film contact (e)(4)(ii), 
-  Compression device performance (e)(4)(iii), 
  Annual QC tests (e)(5) 
-  Dose (e)(5)(vi), 
  Other modalities (e)(6), and 
  Mobile units (e)(7) 
If the physicist becomes aware of problems requiring immediate attention during the course of 
the survey (whether these problems are encountered in the annual tests or not), it is imperative 
that the physicist notifies the facility immediately.  If the violations require repair within 30 days, 
the physicist should inform the facility about these problems in a timely fashion.  The physicist is 
encouraged to work with the facility to ensure that any problems found are corrected.  One 
mechanism to aid in this process would be for the physicist, immediately after the completion of 
the survey to provide the facility with a list of the tests that failed and any additional problems 
found, since the time limit begins from the test date (or discovery of the problem) and not from 
the facility receipt of the survey report. 
Calibration of Air Kerma Measuring Instruments 
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The air kerma measuring instruments used by the medical physicist must be calibrated at least 
once every two years and each time the instrument is repaired (21 CFR 900.12(e)(12)).  The 
instrument must be calibrated to an accuracy of  6 percent (95 percent confidence level) in the 
mammography energy range.  The calibration must be traceable to a national standard, and occur 
at the National Institute for Science and Technology (NIST) or a calibration laboratory that 
participates in a proficiency program with NIST (21 CFR 900.2(xx)).  The calibration of the 
physicists instrument should have been completed within 12 months of the completion of the 
calibration laboratory proficiency test and that test should show the laboratory to be within  3% 
of the national standard in the mammography energy range.  We recommend that the medical 
physicist provide information regarding the calibration of his/her air kerma measuring 
instruments in the survey (and MEE) reports.  
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Table 1: Tests Required for the Annual Survey
Test  Regulatory Action Levels  Scope *  Timing of required corrective 
action** 
AEC performance capability  OD exceeds the mean by more than   All machines, all clinically used  Within 30 days of the date of the test. 
(e)(5)(i)   0.15 (over 2-6 cm homogeneous  target/filter combinations, AEC modes 
material thickness range), or the phantom  and Individually selectable detectors;
image density at center is less than 1.20  kVp/Thickness tracking (2-6 cm,  
appropriate kVps).  
- required in contact mode only. 
- mag. mode testing is required only for 
mammography equipment evaluations 
(MEE) 
KVp accuracy and  Exceeds  5% of indicated or selected  All machines at 3 kVps (for accuracy)   " 
reproducibility (e)(5)(ii)  kVp COV exceeds 0.02  lowest measurable clinical , most 
frequently used clinically, and highest 
clinical obtainable.  (For reproducibility; 
at the most commonly used kVp). 
Focal spot (e)(5)(iii)  Resolution requirement:  All machines, all target materials, focal  " 
13 lp/mm in the direction parallel to chest  spots, and screen/film combinations used 
wall.  clinically 
11 lp/mm in the direction of the anode   -  Contact mode: Most used SID 
cathode axis.  -  Mag mode: for SID w/mag value 
closest to 1.5 
HVL (e)(5)(iv)  See table in regulations  All machines, all clinically used target- " 
filter combinations 
Air kerma and AEC  Reproducibility COV exceeds 0.05  All machines  " 
reproducibility (e)(5)(v) 
Dose (e)(5)(vi)  Exceeds 3.0 mGy (0.3 rad) per exposure  All machines, all clinically used  Before further examinations are 
screen/film combinations, targets, &  performed with unit 
filters used for the standard breast 
X-ray field / light field /  Exceeds 2% SID at chest wall  All machines, all combinations of  Within 30 days of the date of the test 
compression device alignment   Paddle visible on image or paddle outside  collimators, image receptor sizes, targets, 
(e)(5)(vii)  IR > 1%  and focal spots clinically used for full-
field imaging in the contact mode  
Screen speed uniformity  OD variation exceeds 0.30 from the  All cassettes  may be grouped by size  " 
(e)(5)(viii)  maximum to the minimum   and speed  limit holds within groups  
groups must be identifiable to the 
technologist 
System artifacts Determined by physicist  All machines, all clinically used cassette  " 
(e)(5)(ix)  sizes, focal spots & target-filter 
combinations.  All processors 
Radiation output (e)(5)(x)  Less than 7.0 mGy/sec   All machines  " 
Automatic decompression  Failure of override or manual release or  All machines (if auto is provided)  " 
control  (e)(5)(xi)  status indication 
Any applicable tests for other  Action levels not substantially the same  All machines  Before further examinations are 
modalities (e)(6)  as those specified by equipment  performed with unit 
manufacturers 
Phantom image quality test   As specified by the facilitys accreditation  All machines, all target-filter  Before  further examinations are 
(e)(9) see (e)(2)  body (21 CFR 900.4(d)(2))  combinations, all screen-film  performed with unit 
combinations used clinically for the 
average breast 
* Many of the items in this column are discussed in more detail in the Policy Guidance Help System (PGHS) 
currently on FDAs web site.  
** Refer to 21 CFR 900.12(e)(8)(ii)(A) or (B) as applicable 
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Evaluation of the Survey Report by the MQSA Inspector 
Inspection Questions Related to the Survey 
We have generated the following checklist from questions covering the physicist survey that 
will normally be addressed during the annual MQSA inspection.  Included are items relevant to 
the inspectors evaluation of the survey, the physicists qualifications, and the facility response 
to any physicist recommendations.   
  Survey report available? 
  Date of previous survey 
  Date of current survey 
  Survey conducted, assisted, or supervised by (names) 
  Survey complete? 
-  Pass/fail list 
-  Recommendations for failed items 
-  Physicist's evaluation of technologist's QC tests 
a  Processor QC?       [for each processor] 
a  Phantom image?      [for each x-ray unit] 
a  Repeat analysis? 
a  Analysis of fixer retention? [for each processor] 
a  Darkroom fog?      [for each darkroom] 
a  Screen-film contact?    [for all cassettes] 
a  Compression?      [for each x-ray unit] 
-  Collimation 
a  X-ray field - light field alignment 
a  X-ray field - image receptor alignment 
a  Compression device/image receptor edge alignment (chest wall) 
-  Focal spot size/resolution measurement 
a  Done for all clinically used focal spots? 
  Numerical Results Given? 
-  kVp Accuracy 
a  Done at the lowest clinical value measurable, most often used clinically, and highest 
available clinical kVp? 
  Numerical results given? 
-  kVp Reproducibility 
a  Done at the kVp most commonly used clinically? [Regulations specify additional kVps,] 
  Numerical results given? 
-  Beam quality (HVL) measurement 
a Done at the kVp most commonly used clinically? 
  Numerical results given? 
-  AEC performance 
a  Reproducibility 
  Numerical results given? 
a  Performance capability 
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  Done for 2, 4, and 6 cm [at typical kVp(s) for these thicknesses] 
  Numerical results given? 
-  Uniformity of screen speed [for all cassettes used] 
a  Numerical results given? 
-  Dose (including entrance air kerma & reproducibility) 
a  Exposure & HVL at same clinical kVp? 
a  RMI-156 or equivalent phantom? 
a  Numerical results given? 
-  Phantom Image 
a  Done at the kVp normally used clinically? 
a  RMI-156 or equivalent phantom? 
a  3 object scores given? 
-  Artifact evaluation 
-  Radiation output 
-  Decompression 
-  QC Tests - other modalities (if applicable) 
  Action taken? (if called for in survey report) 
MQSA inspectors will usually determine only if the survey documentation contains a clear 
indication that: 
  The physicist performed each test or review (in the case of the facility QC review) and 
that a pass or fail was recorded for each test and QC item; 
  The physicist provided numerical test results (such as COV, kVp accuracy and AEC 
reproducibility, HVL value, dose value, etc.) to the facility; and 
  The report contains a summary of the findings, along with recommendations when the 
findings indicate that one or more of the tests or reviews have not passed.   
The recommendations included in the summary need not be limited to items specifically 
covered by the survey.  The report may include any recommendations resulting from the review 
of the QC test program or other sources that the physicist believes might improve the quality of 
mammography at the facility.  However, the facility is required to implement only those items 
necessary to assure the facilitys compliance with the regulations. 
MQSA Requirements for the Mammography Equipment 
Evaluations (MEE) (see Attachment A) 
When a mammography facility installs new radiographic equipment (x-ray units or processors), 
the new equipment must be evaluated by a qualified medical physicist and the accreditation 
requirements of the facilitys accreditation body must be met before the unit is placed into 
service (21 CFR 900.12(e)(10)).  In this context, new means new to the facility and, 
therefore, includes used equipment.  Mammography equipment evaluations must also be 
performed whenever equipment is disassembled and then reassembled at the same or a new 
location or whenever a major component is changed or repaired.  The MEE is required even if a 
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full survey has recently been completed to verify that all functions, which may have been 
affected by the change or repair, have been successfully restored.   
Scope of the MEE 
With respect to testing of the equipment, the MEE is more extensive than the survey.  It may be 
regarded as an acceptance test for the equipment and an annual survey alone is not sufficient to 
meet this requirement.  The MEE must address all applicable requirements under the equipment 
section of the regulations (21 CFR 900.12(b)) as well as all applicable QC requirements and 
testing under 21 CFR 900.12(e), including applicable daily, weekly, quarterly, semiannual, and 
annual QC tests.  Such testing is only applicable to the specific equipment that is repaired, 
replaced, re-assembled, or added and it is not applicable to other equipment in the facility that 
has not been affected. 
A.  For a newly installed or re-assembled x-ray unit, the medical physicist must: 
1.  Perform all the annual tests listed in section (e)(5) [except (e)(5)(viii), which need not be 
included if the new unit is not the first one to be accredited in the facility unless new cassettes 
are being added], the other modality tests listed in section (e)(6) (if applicable),  the 
phantom image test listed in section (e)(2), the compression force test listed in section 
(e)(4)(iii); and 
2.  Verify that the new x-ray unit meets the equipment standards listed in sections (b)(1-10).  
Furthermore, if the new unit is the first and/or the only one at the facility, then Sections 
(b)(11), (b)(12), (b)(14), and (b)(15), which relate to the screen-film combination and the 
lighting and viewing conditions used at the facility, respectively, must also be verified.  
B.  For a newly installed or reassembled processor, the medical physicist must perform the 
following tests/tasks: 
1.   Sensitometric strip as described in 21 CFR 900.12(e)(1) 
2.  Phantom image quality as described in 21 CFR 900.12(e)(2) 
3.  System artifact evaluation as described in 21 CFR 900.12(e)(5)(ix)   
4.  Dose determination as described in 21 CFR 900.12(e)(5)(vi)  if clinical techniques increase 
significantly 
5.  Verification of the appropriate processing solutions as described in 21 CFR 900.12(b)(13). 
We also recommend that the medical physicist conduct the Darkroom Fog test if the integrity 
of the darkroom is compromised, and to conduct the fixer retention analysis test, if deemed 
necessary. 
Each processor used clinically must have an MEE, even those at remote sites (if any). 
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Examples of major changes or repairs that would call for an MEE include, but are not limited 
to: 
  Replacement of an x-ray tube, collimator, filter, AEC, or AEC sensor.  
  A total overhaul of the processor.   
Routine processor preventive maintenance, pump replacement, replacement of the developer or 
fixer racks, replacement of the control board or changes in chemistry brand are not considered to 
be major changes or repairs and, consequently, would not require evaluation by a medical 
physicist.   
These evaluations are used by the facility, its accreditation body, and the MQSA inspector to 
determine whether the new or changed equipment meet the requirements of applicable standards 
in 21 CFR 900.12(b) and (e).  Consequently, the physicist should provide the facility with 
sufficient documentation that clarifies both the testing performed and the test results.  The 
medical physicist (after consultation with the FDA, if necessary) should decide which tests need 
to be performed following a particular repair, and should be prepared to explain the rationale 
behind his or her decision.  Before the new or changed equipment is put into service for patient 
examinations or processing mammograms, the facility must correct all problems relating to the 
regulations (21 CFR 900.12(e)(10)).  There is no provision for a 30-day correction period such as 
with some QC and physics survey test results.   
To get a more detailed list of items/tests that are defined as major repairs and or other tests that 
require the physicist to conduct in person, consult our PGHS, which also provides guidance on 
many related topics. 
Note also that the 1999 ACR QC manual provides Equipment Evaluation forms for the physicists 
to use.  These forms list all the MQSA requirements in a table format that is easy to review and 
evaluate. 
For More Information 
FDA maintains an MQSA Internet site at http://www.fda.gov/cdrh/mammography/.  The site 
contains many useful items, including current information about the mammography program and 
the on-line Policy Guidance Help System.  If you have questions on how to prepare for 
inspections, call FDA's Facility Hotline at (800) 838-7715, or FAX your request to (410) 290-
6351. 
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MQSA Medical Physicists Qualification Requirements (see 
Attachment C) 
During the annual MQSA inspection, the inspector will evaluate the medical physicists 
qualifications against the requirements in the MQSA and its implementing regulations (see 21 
CFR 900.12(a)(3) in Attachment C).  All medical physicists, including those who were board 
certified, State licensed, or State approved prior to April 28, 1999, will be evaluated. 
The qualifications for the medical physicist are relatively complicated because the initial 
requirements may vary depending upon qualification date.  As an aid to understanding them, we 
have separated the medical physicist section into three parts.   
A.  The requirements for those physicists who are qualifying through the masters degree or 
higher route 
B.  The requirements for those who are qualifying through the alternative initial 
requirements approach covering education, training, and experience 
C.  The continuing qualification requirements applicable to all physicists  
All qualifying medical physicists must demonstrate compliance with either A or B below. 
The continuing education and experience requirements covered in C are applicable to all 
physicists. 
 
A.  All medical physicists qualifying under the masters degree or higher route must 
demonstrate: 
1.  a.  Licensure or approval:  Be licensed or approved by a State to perform  
    mammography surveys. 
OR 
b. Board Certification:  Be certified in diagnostic medical physics or medical 
  physics by one of the following: 
i.  The American Board of Radiology (ABR) 
ii.  The American Board of Medical Physics (ABMP) 
AND 
 
2.  Education, training, and experience: 
a.  Degree:  Have a Masters degree or higher in a physical science with at least 20 
semester hours (30 quarter hours) of graduate or undergraduate physics. 
AND 
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b.  Survey Training:  Have at least 20 contact hours of mammography facility 
survey training. 
AND 
c.  Initial Experience:  Have the experience of conducting surveys of at least one 
mammography facility and a total of at least 10 mammography units. 
B.  Certain medical physicists may have qualified under the interim regulations before April 
28, 1999, through the State approval or licensing mechanism or through the professional 
certification route without having the appropriate degree to meet the final regulations as 
described above.  Such medical physicists may qualify under the Alternative Initial 
Qualifications route.  Such individuals must demonstrate that, by April 28, 1999, they 
had achieved compliance with the following: 
1.  a. Licensure or approval:  Be licensed or approved by a State to perform 
mammography surveys. 
OR 
b.  Board Certification:  Be certified in diagnostic medical physics or medical 
physics by one of the following: 
i.  The American Board of Radiology (ABR) 
ii.  The American Board of Medical Physics (ABMP) 
AND 
 
2.  Education, training, and experience: 
a. Degree:  Have a bachelors degree in a physical science with at least 10 semester 
hours (15 quarter hours) of graduate or undergraduate physics.  (This would 
include individuals having advanced degrees in non-physical science fields.) 
AND 
b. Survey Training:  Have at least 40 contact hours of mammography facility survey 
training.  This training must have occurred after fulfilling the degree requirement 
in 2.a. 
AND 
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c. Initial Experience:  Have the experience of conducting surveys of at least one 
mammography facility and a total of at least 20 mammography units.  This initial 
experience must have occurred after fulfilling the degree requirement in 2.a. 
C.  All medical physicists must meet the following requirements: 
1.  New Mammographic Modality:  Before a physicist may begin independently 
performing surveys or equipment evaluations on any mammographic modalities in 
which the physicist was not previously trained (e.g., xeromammography, digital 
mammography, screen-film mammography), the physicist must have at least 8 hours 
of training in the modality. 
AND 
 
4.  Continuing Experience: The physicist must have conducted a minimum of two 
mammography facility surveys and a total of six mammography unit surveys (or 
equipment evaluations which cover all of the equipment survey items) during the 24 
months immediately preceding the date of the facility's annual MQSA inspection, or 
the last day of the calendar quarter preceding the inspection, or any date in between 
the two. 
The starting date for this requirement is April 28, 1999, or the date on which the 
physicist initially qualifies to work independently, whichever is later.  Failure to meet the 
physicists continuing experience requirement will not be considered a noncompliance 
until the later of July 1, 2001, or 24 months after the physicists starting date. 
AND 
 
3.  Continuing Education:  Have taught or completed at least 15 continuing education 
units in medical physics or mammography during the 36 months immediately 
preceding the date of the facility's annual MQSA inspection, or the last day of the 
calendar quarter preceding the inspection, or any date in between the two.  CEUs 
earned through teaching a course can be counted only once toward meeting the 15 
units required in any 36-month period.  The continuing education must include 
training appropriate to each mammographic modality evaluated by the medical 
physicist.  Note: Inspectors will not cite facilities for the mammography modality 
specific continuing education requirement before April 28, 2006. 
      
The starting date for this requirement is October 1, 1994, or the date on which the 
physicist initially qualifies to work independently, whichever is later.  Failure to meet the 
physicists continuing education requirement will not be considered a noncompliance 
until 36 months after the physicists starting date. 
NOTE:  For meeting the requirements in items A.2.b., A.2.c., B.2.b., B.2.c., and C.2., FDA 
allows multiple testing of the same mammography unit.  However, no more than one survey of a 
  17  Contains Nonbinding Recommendations 
 
specific facility within a 10-month period can be counted toward the total requirement, and tests 
of the same unit cannot be counted more than once in any consecutive 60-day period.  It is 
important enough to repeat that, for the alternative initial qualifications route, the training and 
experience in items B.2.b. and B.2.c. must have been obtained after the qualifying degree 
requirements are satisfied and before April 28, 1999. 
Additional Guidance 
Alternative Initial Qualification 
This area is of particular concern for some medical physicists.  Those who qualified under the 
interim regulations using only the state licensure or approval mechanism and those using the 
professional certification provision who do not meet the degree requirements under the April 28, 
1999, regulations must meet the requirements of the Alternative Initial Qualifications.  This 
provision specifies that, before these individuals can perform MQSA facility surveys, they must 
meet the following requirements: 
  Have a bachelors degree or higher, in a physical science 
  Have a minimum of 10 semester hours (or equivalent) of college level physics 
  Have 40 contact hours of documented specialized training conducting mammography 
facility surveys 
  Have performed surveys on at least one mammography facility and a total of at least 20 
mammography units 
  Have obtained the initial survey training and experience after meeting the degree 
requirement  
All of the above must have been completed by the April 28, 1999, deadline. 
Qualifying Degree 
All qualifying degrees must be from the physical sciences.  In this context, a physical science 
degree means a degree in one of the specialties or subspecialties of physics, chemistry, radiation 
science, or engineering.  A degree in all subspecialties in radiation science that involve the study 
or use of radiation may be considered as a radiation science degree. 
Again, for those physicists qualifying with a bachelors degree, both the 40 hours of training and 
the experience requirements must have been met after completing the degree requirements. 
Specialized Training 
Physicists may use various types of training to meet the requirement for specialized training in 
conducting surveys, including continuing education units (CEU), formal academic training, or 
other types of training programs. 
  18  Contains Nonbinding Recommendations 
 
For meeting the continuing education requirement for physicists, FDA accepts CEU credits or 
units related either to the diagnosis and/or treatment of breast disease or to areas that will aid 
medical physicists in improving the quality of the survey.  To satisfy the specialized survey 
training requirements, CEUs must be specifically related to technical or quality assurance topics 
pertinent to mammography facility surveys.  Therefore, not all CEUs, acceptable as continuing 
education units, will satisfy the requirement for specialized training. 
Physicists who qualified and obtained their survey training prior to April 28, 1999, may count the 
survey training for both CEUs and the "specialized training in conducting surveys" requirement.  
However, physicists who completed their qualifications after April 28, 1999, may only use the 
survey training to meet their initial requirements and may not use the training as CEUs. 
Physicists who originally qualified using the education, training, and experience route under the 
interim regulations will meet the final regulations requirements if their experience included at 
least 10 mammography unit surveys and one complete facility survey, including the evaluation of 
technologist QC records. 
Direct Supervision 
After April 28, 1999, the regulations require that the initial survey experience be under the direct 
supervision of a medical physicist who qualified under 21 CFR 900.12(a)(3)(i) and (iii) (see 
Attachment C).  This means that, after that date physicists who qualified under the alternate 
initial qualifications (21 CFR 900.12(a)(ii)) will no longer be able to provide the direct 
supervision required for the initial or requalification experience requirement.  Physicists who 
initially qualify under the alternative route, and who subsequently upgrade their educational 
background and/or their professional certification status so that they now qualify under the 
requirements of 21 CFR 900.12(a)(3)(i) and (iii), may provide this required supervision.  The 
qualifications of such individuals are equal to those who initially qualify under 21 CFR 
900.12(a)(3)(i) and (iii).  However, the initial qualification date for these physicists will remain 
unchanged.  
MQSA requires that the survey (or mammography equipment evaluation) be conducted by or 
under the direct supervision of a medical physicist. The goal of direct supervision is to provide 
reasonable assurance that any mistakes made by the supervisee are corrected before program 
reviews or tests are completed. 
For the physics survey and/or mammography equipment evaluation, direct supervision means 
that the supervisor (if the supervision occurs after 4/28/99, the supervising medical physicist 
must have qualified under the masters or higher route) is present to observe and correct, as 
needed, the performance of the supervisee (21 CFR 900.2(o)(2)).  This means that the supervisor 
need to be in the room during the performance of the individual equipment tests to assure that 
any mistakes made by the supervisee are corrected before the test is completed. 
Furthermore, when conducting a survey, the supervisor and supervisee must jointly review the 
QC program records.  The supervisor does not have to be present when the supervisee initially 
  19  Contains Nonbinding Recommendations 
 
reviews the QC program records.  However, the supervisor must review, discuss, confirm, and if 
necessary, correct the findings made by the supervisee prior to either the initial or final survey 
report being issued. 
New Mammographic Modality Training 
After April 28, 1999, before a medical physicist may begin independently surveying or 
performing equipment evaluations on a new mammographic modality for radiography of the 
breast, he or she must obtain 8 hours of training in surveying that new mammographic modality 
(21 CFR 900.12(a)(3)(iii)(C)).  FDA defines a new modality as a technology for which the 
physicist has not been previously trained.  If the physicist started using this mammographic 
modality before April 28, 1999, the 8-hour training requirement does not apply.  The physicist 
can obtain the required training from many sources, including special training courses, 
continuing education, and training provided by the manufacturer of the mammographic modality. 
Initial and Continuing Experience  
FDA recognizes that some physicists may be unable to visit multiple facilities to meet the 
experience requirements.  FDA, therefore, allows the survey of the same facility and the same 
mammography units to count towards the total requirements for initial, continuing, and re-
qualification (21 CFR 900.12(a)(3)(iv)) requirements.  However, there are restrictions on the 
frequency under which such re-surveying will be allowed.  For the unit survey requirements in 
each of these categories, physicists can count no more than one survey of any single unit in any 
60-day period towards the total.  For both the continuing experience and re-qualification 
requirements, the physicist can count no more than one survey of a specific facility in any 10-
month period. 
Continuing Education 
The medical physicist must also meet specific continuing education requirements.  The medical 
physicist must have completed at least 15 CEUs, which must include, in the 36 months preceding 
the inspection (or the last day of the calendar quarter preceding the inspection or any date in 
between the two), hours in each mammographic modality for which he or she provides medical 
physics support.  As discussed above, all CEUs related to the diagnosis or treatment of breast 
disease or other areas that will aid facility personnel in improving the quality of mammography 
may be acceptable toward meeting the continuing education requirement.  Diagnostic medical 
physics continuing education that is not directly related to mammography or general continuing 
education in mammography that is unrelated to medical physics may also be acceptable.  
However, physicists must make sure they obtain continuing education appropriate to each 
mammographic modality evaluated in their practice, even if this action causes the required total 
to exceed 15 hours.  Note: Inspectors will not cite facilities for the mammography modality 
specific continuing education requirement before April 28, 2006. 
  20  Contains Nonbinding Recommendations 
 
Documentation 
It is the responsibility of the facility to have adequate documentation available to establish the 
physicists qualifications.  This documentation must (21 CFR 900.12(a)(4)) include information 
covering the initial qualifications, continuing experience, and continuing education for the 
medical physicist.  The physicist should assist in this process by providing the necessary 
materials to each facility where the physicist provides professional services. At the time of the 
inspection, the continuing education and experience for the medical physicist must include 15 
CEUs in the previous 36 months and the survey of at least two facilities and six units in the 
previous 24 months, respectively.  The medical physicist should be aware that each facility may 
elect to maintain its personnel continuing experience and continuing education records on 
different time schedules and should attempt to provide the necessary information to each facility 
in a timely manner.  Table 2 lists examples of acceptable documentation for the medical 
physicist. 
  21  Contains Nonbinding Recommendations 
 
Table 2: Acceptable Documentation for the Medical Physicists Qualifications 
Requirement Obtained Prior to 10/1/94 Obtained 10/1/94-4/28/99 Obtained After 4/28/99
State Licensure or Approval 1. State license or approval/copy with  1.  State license or approval/copy with  1. State license or approval/copy with 
expiration date expiration date  expiration date 
2. Confirming letter from State licensing  2.  Confirming letter from State licensing  2. Confirming letter from State licensing 
board  board  board 
3. FDA Approval Letter 3.  FDA Approval Letter 3. FDA Approval Letter
Board Certification 1. Original/copy of certificate  1.  Original/copy of certificate  1. Original/copy of certificate 
(ABR or ABMP) 2. Confirming letter from certifying board 2.  Confirming letter from certifying board 2. Confirming letter from certifying board 
3. Pocket card/copy of certificate 3.  Pocket card/copy of certificate 3. Pocket card/copy of certificate
4. Confirming letter from ACR  4.  Confirming letter from ACR  4. Confirming letter from ACR 
5. FDA Approval Letter 5.  FDA Approval Letter 5. FDA Approval Letter  
Degree in a physical science-final  1. Original/copy of diploma  1.  Original/copy of diploma  1. Original/copy of diploma 
regs (Masters pathway)  2. Confirming letter from college or  2.  Confirming letter from college or  2. Confirming letter from college or 
(Bachelors pathway -alternative) university university university
3. FDA Approval Letter 3.  FDA Approval Letter 3. FDA Approval Letter
Initial physics education-final regs  1. College or university transcripts 1.  College or university transcripts 1. College or university transcripts
(20 semester hours) 2. Confirming letter from college or  2.  Confirming letter from college or  2. Confirming letter from college or 
(10 semester hours -alternative) university university university
3. Master or Bachelor degree specifically  3.  Master or Bachelor degree specifically  3. Master or Bachelor degree specifically 
in physics  in physics  in physics
4. FDA Approval Letter 4.  FDA Approval Letter 4. FDA Approval Letter
Survey Training-final regs 1. Attestation 1.  Letter or other document from training  1. Letter or other document from training 
(20 contact hours) 2. Letter or other document from training  program program
(40 contact hours -alternative) program 2.  CME/CEU in mammography or  2. CME/CEU in mammography or medical 
3. CME/CEU in mammography or medical  medical physics  physics
physics  3.  Letter or other document confirming in- 3. Letter or other document confirming in-
4. Letter or other document confirming in- house or formal training house or formal training
house or formal training 4.  Training gained performing surveys  4. Training gained performing supervised 
5. Training gained performing surveys  5.  FDA Approval Letter surveys
6. FDA Approval Letter 5. FDA Approval Letter
Initial Experience-final regs  1. Attestation 1.  Copy or coversheet of survey 1. Copy or coversheet of survey done 
(1 facility-10 units)  2. Copy or coversheet of survey 2.  Letter from facility or listing from  under direct supervision
(1 facility-20 units -alternative) 3. Letter from facility or listing from  company providing the physics  2. Letter from facility or listing from 
company providing the physics  survey services documenting  company providing the physics 
survey services documenting  performance of survey done  survey services documenting 
performance of survey done  3.  FDA Approval Letter performance of survey done under 
4. FDA Approval Letter direct supervision
3. FDA Approval Letter
Initial Mammography Modality  1. Attestation  1.  Mammography modality specific  1. Mammography modality specific 
Specific training (8 hours-final  2. Mammography modality specific  CME/CEU certificates   CME/CEU certificates  
regs)  CME/CEU certificates   2.  CME/CEU certificates plus agenda,  2. CME/CEU certificates plus agenda, 
3. CME/CEU certificates  plus agenda,  course outline, or syllabus  course outline, or syllabus 
course outline, or syllabus 3.  Confirming letters from CME/CEU  3. Confirming letters from CME/CEU 
4. Confirming letters from CME/CEU  granting organizations granting organizations
granting organizations  4.  Letters, certificates, or other documents  4. Letters, certificates, or other documents 
5. Letters, certificates, or other documents  from manufacturers or other formal  from manufacturers or other formal 
from manufacturers or other formal  training courses  training courses 
training courses
Continuing Experience N/A N/A 1. Copy or coversheet of survey 
(2 facilities-6 units/24 months-final  2. Letter from facility or listing from 
regs)  company providing the physics 
survey services documenting 
performance of survey done
Continuing Education (15 CME/36  N/A 1.  CME/CEU certificates   1. CME/CEU certificates  
months) 2.  Confirming letters from CME/CEU  2. Confirming letters from CME/CEU 
granting organizations granting organizations
3.  Letters, certificates, or other documents  3. Letters, certificates, or other documents 
from manufacturers or other formal  from manufacturers or other formal 
training courses  training courses 
Continuing Mammographic  N/A 1.  Mammography modality specific  1. Mammography Modality Specific 
Modality Specific Education-final  CME/CEU certificates   CME/CEU certificates  
regs  2.  CME/CEU certificates (plus agenda,  2. CME/CEU certificates (plus agenda, 
course outline, or syllabus) course outline, or syllabus)
3.  Confirming letters from CME/CEU  3. Confirming letters from CME/CEU 
granting organizations granting organizations
4.  Letters, certificates, or other documents  4. Letters, certificates, or other documents 
from manufacturers or other formal  from manufacturers or other formal 
training courses  training courses 
Requalification-Experiencefinal  N/A N/A 1. Copy or coversheet of survey done 
regsdone under direct supervision under direct supervision
2. Letter from facility or listing from 
company providing the physics 
survey services documenting 
  22  Contains Nonbinding Recommendations 
 
performance of survey done under 
direct supervision
Requalification- Education N/A 1.  CME/CEU certificates   1. CME/CEU certificates  
2.  Confirming letters from CME/CEU  2. Confirming letters from CME/CEU 
  granting organizations granting organizations
  3.  Letters, certificates, or other documents  3. Letters, certificates, or other documents 
from manufacturers or other formal  from manufacturers or other formal 
training courses  training courses 
  23  Contains Nonbinding Recommendations 
 
Attestation 
Individuals attempting to establish their qualifications as medical physicists may attest to certain 
training and experience requirements that were obtained prior to October 1, 1994.  In addition, 
FDA will also accept attestation from medical physicists in situations where a continuing 
education provider does not specifically document the applicability of their CEUs to 
mammography.  The attestation should include documentation showing the total number of 
CEUs earned in the program and documentation showing the total number of CEUs specific to 
mammography that were available.  FDA will not accept attestation for establishing any 
qualifying degree requirements, including the required number of hours in physics, even if these 
conditions were satisfied prior to October 1, 1994.  All attestations should be in the proper 
format.  We have included a sample as Attachment D. 
Inspection 
Both MQSA and the regulations require that the survey be conducted by a medical physicist who 
meets specific qualification requirements.  MQSA inspectors are required to confirm that the 
report of the annual survey is signed by (or contains the identification of) the qualified medical 
physicist who actually conducted or directly supervised the conduct of the survey.  It is not a 
requirement that the report contain a handwritten signature; rather, the report must indicate the 
name of the fully qualified medical physicist who conducted or directly supervised the conduct of 
the survey.  If other personnel assisted in the survey (an assistant, a trainee, or person attempting 
to meet the experience requirements) their name(s) must be included.  In the case of such 
training surveys, FDA will assess only the qualifications of the supervising medical 
physicist during the inspection. 
Inspection Questions Related to the Physicists 
Qualifications 
The following items are adapted from questions the inspector will routinely complete during 
the annual MQSA inspection.  
  Evaluation 
-  Qualifying Degree 
a  Masters (or higher) 
a  Bachelors 
a  No Degree 
  If you checked Masters or higher: 
-  Initial Qualification Requirements met? 
a  Certified (OR) 
a  State licensed or approved 
a  Masters degree in a physical science (w/20 semester hours in physics) 
a  20 contact hours training 
  24  Contains Nonbinding Recommendations 
 
a  experience in conducting surveys (1 facility & 10 units) 
  If you checked Bachelors: 
-  Qualified under interim rules? (prior to 4/28/99) 
a  Certified (OR) 
a  State licensed or approved 
a  Bachelors degree in a physical science (w/10 semester hours in physics), 
(physical science: physics, chemistry, engineering, radiation science) 
a  40 contact hours. training in surveys (after Bachelors) 
a  experience in conducting surveys (after Bachelors), (1 facility & 20 units) 
  Date completed initial requirements  mm/dd/yyyy 
  New Modality Training [8 hours] (if applicable) 
  Continuing Experience adequate? (2 facilities & 6 units/24 months) 
  Continuing Education 
-  CME/CEU Credits/year adequate? (15/36 months) 
-  If n, then: 
-  Number of CME/CEUs in 36 months 
You are reminded that all of the survey requirements in both MQSA and the regulations are 
applicable to each annual survey and the responsible physicist at the mammography facility.  
The preceding questions represent only what the inspectors will be evaluating on a routine 
basis.  If the inspectors believe that it would be beneficial to their understanding of the 
performance of the facility or of the physicist, they may look for information not listed above. 
  25  Contains Nonbinding Recommendations 
 
Attachment A 
Requirement for the Medical Physicists Survey and Mammography Equipment 
Evaluations 
21 CFR 900.12(d)(1)(iii) 
Medical physicist. Each facility shall have the services of a medical physicist available to survey 
mammography equipment and oversee the equipment-related quality assurance practices of the 
facility. At a minimum, the medical physicist(s) shall be responsible for performing the surveys 
and mammography equipment evaluations and providing the facility with the reports described 
in paragraphs (e)(9) and (e)(10) of this section. 
21 CFR 900.12(e)(9) 
Surveys. 
(i)   At least once a year, each facility shall undergo a survey by a medical physicist or by an 
individual under the direct supervision of a medical physicist.  At a minimum, this survey 
shall include the performance of tests to ensure that the facility meets the quality assurance 
requirements of the annual tests described in paragraphs (e)(5) and (e)(6) of this section 
and the weekly phantom image quality test described in paragraph (e)(2) of this section. 
(ii)  The results of all tests conducted by the facility in accordance with paragraphs (e)(1) 
through (e)(7) of this section, as well as written documentation of any corrective actions 
taken and their results, shall be evaluated for adequacy by the medical physicist 
performing the survey. 
(iii)  The medical physicist shall prepare a survey report that includes a summary of this review 
and recommendations for necessary improvements. 
(iv)   The survey report shall be sent to the facility within 30 days of the date of the survey. 
(v)   The survey report shall be dated and signed by the medical physicist performing or 
supervising the survey.  If the survey was performed entirely or in part by another 
individual under the direct supervision of the medical physicist, that individual and the part 
of the survey that individual performed shall also be identified in the survey report. 
21 CFR 900.12(e)(10) 
Mammography equipment evaluations.  Additional evaluations of mammography units or image 
processors shall be conducted whenever a new unit or processor is installed, a unit or processor 
is dissembled and reassembled at the same or a new location, or major components of a 
mammography unit or processor equipment are changed or repaired.  These evaluations shall be 
used to determine whether the new or changed equipment meets the requirements of applicable 
standards in paragraphs (b) and (e) of this section.  All problems shall be corrected before the 
new or changed equipment is put into service for examinations or film processing.  The 
mammography equipment evaluation shall be performed by a medical physicist or by an 
individual under the direct supervision of a medical physicist. 
  26  Contains Nonbinding Recommendations 
 
Attachment B 
QC Tests - Annual 
21 CFR 900.12(e)(5) 
Annual quality control tests.  Facilities with screen-film systems shall perform the following quality 
control tests at least annually: 
(i)  Automatic exposure control performance. 
(A) The AEC shall be capable of maintaining film optical density within <plus-minus> 0.30 
of the mean optical density when thickness of a homogeneous material is varied over a 
range of 2 to 6 cm and the kVp is varied appropriately for such thicknesses over the kVp 
range used clinically in the facility.  If this requirement cannot be met, a technique chart 
shall be developed showing appropriate techniques (kVp and density control settings) 
for different breast thicknesses and compositions that must be used so that optical 
densities within <plus-minus> 0.30 of the average under phototimed conditions can be 
produced. 
(B)  After October 28, 2002, the AEC shall be capable of maintaining film optical density 
(OD) within <plus-minus> 0.15 of the mean optical density when thickness of a 
homogeneous material is varied over a range of 2 to 6 cm and the kVp is varied 
appropriately for such thicknesses over the kVp range used clinically in the facility. 
(C)  The optical density of the film in the center of the phantom image shall not be less than 
1.20. 
(ii)   Kilovoltage peak (kVp) accuracy and reproducibility. 
(A)  The kVp shall be accurate within <plus-minus> 5 percent of the indicated or selected 
kVp at: 
(1)  The lowest clinical kVp that can be measured by a kVp test device; 
(2)  The most commonly used clinical kVp; 
(3)  The highest available clinical kVp, and 
(B)  At the most commonly used clinical settings of kVp, the coefficient of variation of 
reproducibility of the kVp shall be equal to or less than 0.02. 
(iii)   Focal spot condition.  Until October 28, 2002, focal spot condition shall be evaluated either 
by determining system resolution or by measuring focal spot dimensions.  After October 28, 
2002, facilities shall evaluate focal spot condition only by determining the system resolution. 
  (A)  System Resolution. 
(1)  Each X-ray system used for mammography, in combination with the 
mammography screen-film combination used in the facility, shall provide a 
minimum resolution of 11 Cycles/millimeters (mm) (line-pairs/mm) when a high 
contrast resolution bar test pattern is oriented with the bars perpendicular to 
the anode-cathode axis, and a minimum resolution of 13 line-pairs/mm when 
the bars are parallel to that axis. 
(2)  The bar pattern shall be placed 4.5 cm above the breast support surface, 
centered with respect to the chest wall edge of the image receptor, and with the 
edge of the pattern within 1 cm of the chest wall edge of the image receptor. 
  27  Contains Nonbinding Recommendations 
 
(3)  When more than one target material is provided, the measurement in paragraph 
(e)(5)(iii)(A) of this section shall be made using the appropriate focal spot for each 
target material. 
(4)  When more than one SID is provided, the test shall be performed at SID most 
commonly used clinically. 
(5)  Test kVp shall be set at the value used clinically by the facility for a standard 
breast and shall be performed in the AEC mode, if available.  If necessary, a 
suitable absorber may be placed in the beam to increase exposure times.  The 
screen-film cassette combination used by the facility shall be used to test for this 
requirement and shall be placed in the normal location used for clinical 
procedures. 
(B)  Focal spot dimensions.  Measured values of the focal spot length (dimension parallel to 
   the anode cathode axis) and width (dimension perpendicular to the anode cathode axis) 
   shall be within the tolerance limits specified in Table 1 [for the table, see the Code of 
Federal Regulations or Federal Register( Vol. 62, N0. 208, page 55990)]. 
(iv)   Beam quality and half-value layer (HVL).  The HVL shall meet the specifications of Sec. 
1020.30(m)(1) of this chapter for the minimum HVL.  These values, extrapolated to the 
mammographic range, are shown in Table 2 [for the table see the Code of Federal 
Regulations or  the Federal Register (Vol. 62, N0. 208, page 55990)]. Values not shown 
in Table 2 may be determined by linear interpolation or extrapolation. 
(v)   Breast entrance air kerma and AEC reproducibility.  The coefficient of variation for both air 
kerma and mA's shall not exceed 0.05. 
(vi)   Dosimetry.  The average glandular dose delivered during a single cranio-caudal view of 
an FDA-accepted phantom simulating a standard breast shall not exceed 3.0 milligray 
(mGy) (0.3 rad) per exposure.  The dose shall be determined with technique factors and 
conditions used clinically for a standard breast. 
(vii)   X-ray field/light field/image receptor/compression paddle alignment. 
(A)  All systems shall have beam-limiting devices that allow the entire chest wall edge of 
the x-ray field to extend to the chest wall edge of the image receptor and provide 
means to assure that the x-ray field does not extend beyond any edge of the image 
receptor by more than 2 percent of the SID. 
  (B)  If a light field that passes through the X-ray beam limitation device is provided, it 
shall be aligned with the X-ray field so that the total of any misalignment of the 
edges of the light field and the X-ray field along either the length or the width of the 
visually defined field at the plane of the breast support surface shall not exceed 2 
percent of the SID. 
(C)  The chest wall edge of the compression paddle shall not extend beyond the chest wall 
edge of the image receptor by more than one percent of the SID when tested with the 
compression paddle placed above the breast support surface at a distance equivalent to 
 standard breast thickness.  The shadow of the vertical edge of the compression paddle 
shall not be visible on the image. 
(viii)   Uniformity of screen speed.  Uniformity of screen speed of all the cassettes in the facility shall 
be tested and the difference between the maximum and minimum optical densities shall not 
exceed 0.30.  Screen artifacts shall also be evaluated during this test. 
  28  Contains Nonbinding Recommendations 
 
(ix)   System artifacts.  System artifacts shall be evaluated with a high-grade, defect-free sheet 
of homogeneous material large enough to cover the mammography cassette and shall be 
performed for all cassette sizes used in the facility using a grid appropriate for the 
cassette size being tested.  System artifacts shall also be evaluated for all available focal 
spot sizes and target filter combinations used clinically. 
(x)   Radiation output. 
  (A)   The system shall be capable of producing a minimum output of 4.5 mGy air kerma 
per second (513 milli Roentgen (mR) per second) when operating at 28 kVp in the 
standard mammography (moly/moly) mode at any SID where the system is designed 
to operate and when measured by a detector with its center located 4.5 cm above 
the breast support surface with the compression paddle in place between the source 
and the detector.  After October 28, 2002, the system, under the same measuring 
conditions shall be capable of producing a minimum output of 7.0 mGy air kerma 
per second (800 mR per second) when operating at 28 kVp in the standard 
(moly/moly) mammography mode at any SID where the system is designed to 
operate. 
  (B)   The system shall be capable of maintaining the required minimum radiation output 
averaged over a 3.0 second period. 
(xi)  Decompression.  If the system is equipped with a provision for automatic decompression 
after completion of an exposure or interruption of power to the system, the system shall 
be tested to confirm that it provides: 
  (A)   An override capability to allow maintenance of compression; 
  (B)   A continuous display of the override status; and 
  (C)   A manual emergency compression release that can be activated in the event of power  
       or automatic release failure. 
21 CFR 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. 
21 CFR 900.12(e)(7) 
Mobile Units.  The facility shall verify that mammography units used to produce mammograms 
at more than one location meet the requirements in paragraphs (e)(1) through (e)(6) of this 
section.  In addition, at each examination location, before any examinations are conducted, the 
facility shall verify satisfactory performance of such units using a test method that establishes the 
adequacy of the image quality produced by the unit. 
21 CFR 900.12(e)(8) 
Use of test results. 
(i)   After completion of the tests specified in paragraphs (e)(1) through (e)(7) of this section, the 
facility shall compare the test results to the corresponding specified action limits; or, for 
nonscreen-film modalities, to the manufacturer's recommended action limits; or, for post-
  29  Contains Nonbinding Recommendations 
 
move, preexamination testing of mobile units, to the limits established in the test method 
used by the facility. 
(ii)  If the test results fall outside of the action limits, the source of the problem shall be 
identified and corrective actions shall be taken: 
(A) Before any further examinations are performed or any films are processed using the 
component of the mammography system that failed the test, if the failed test was that 
described in paragraphs (e)(1), (e)(2), (e)(4)(i), (e)(4)(ii), (e)(4)(iii), (e)(5)(vi), (e)(6), or 
(e)(7) of this section; 
(B) Within 30 days of the test date for all other tests described in paragraph (e) of this 
section. 
  30  Contains Nonbinding Recommendations 
 
Attachment C 
MQSA Personnel Requirements For Medical Physicists 
21 CFR 900.12(a)(3) 
All medical physicists conducting surveys of mammography facilities and providing oversight of 
the facility quality assurance program under paragraph (e) of this section shall meet the 
following: 
21 CFR 900.12(a)(3)(i) 
Initial Qualifications 
(A)  Be State licensed or approved or have certification in an appropriate specialty area by one 
of the bodies determined by FDA to have procedures and requirements to ensure that 
medical physicists certified by the body are competent to perform physics survey; and  
(B)  (1)  Have a masters degree or higher in a physical science from an accredited institution, 
with no less than 20 semester hours or equivalent (e.g., 30 quarter hours) of college 
undergraduate or graduate level physics. 
 (2)  Have 20 contact hours of documented specialized training in conducting surveys of 
mammography facilities. 
  (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; or 
21 CFR 900.12(a)(3)(ii)  Alternative Initial Qualifications 
(A)  Have qualified as a medical physicist under paragraph (a)(3) of this section of FDAs 
interim regulations and retained that qualification by maintenance of the active status of 
any licensure, approval, or certification required under the interim regulations; and 
(B)  Prior to the April 28, 1999, have: 
  (1)  A bachelors degree or higher in a physical science from an accredited institution with 
no less than 10 semester hours or equivalent of college undergraduate or graduate 
level physics, 
  (2) Forty contact hours of documented specialized training in conducting surveys of 
mammography facilities, and 
  (3) Have the experience of conducting surveys of at least 1 mammography facility and a 
total of at least 20 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. The training and experience requirements must be met after fulfilling the 
degree requirement. 
  31  Contains Nonbinding Recommendations 
 
21 CFR 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 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 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. 
21 CFR 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 paragraph (a)(3)(i) or (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 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 the total mammography unit survey requirement. 
(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. 
21 CFR 900.12(a)(3)(iv) Reestablishing qualifications. 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. 
(B) Medical physicists who fail to meet the continuing experience requirement of paragraph 
(a)(3)(iii)(B) of this section shall complete a sufficient number of surveys under the direct 
supervision of a medical physicist who meets the qualifications of paragraphs (a)(3)(i) and 
(a)(3)(iii) of this section to bring their total surveys up to the required two facilities and six 
units in the previous 24 months. 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. 
  32  Contains Nonbinding Recommendations 
 
Attachment D 
ATTESTATION FORM 
Regarding Requirements of the Mammography Quality Standards Act 
Please include as much of the following information as possible:   
Name of the institution/facility where the applicable training or mammography 
reading/interpreting, or other activity, took place; name of the course(s) or training (where 
applicable); the attendance, reading/interpreting, or other activity dates; and the 
supervising/responsible person (where applicable) for the institution/facility.  
Please provide these details in the space below.  Attach additional sheets if necessary. 
I, ________________________, attest that, to the best of my knowledge and my belief, the 
following information provided in this declaration is true and correct. I understand that 
FDA may request additional information to substantiate the statements made in this 
declaration:   
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
______________ 
                                            
I understand that knowingly providing false information in a matter within the 
jurisdiction of an agency of the United States could result in criminal liability, punishable 
by up to $10,000 fine and imprisonment of up to five years, or civil liability under the 
MQSA, or both. 
____________________________________________________________________________
Attester's Signature and Title 
_____________________ 
Date signed 
   
Facility Name and Address (if applicable) including zip code: 
___________________________________ 
___________________________________ 
___________________________________ 
Facility ID Number (if applicable) from the Facility's MQSA certificate 
  33