The Mammography Quality 

Standards Act Final Regulations: 

Preparing for MQSA Inspections; 

Final Guidance for Industry and 

FDA 

Document issued on November 5, 2001

This document supersedes Preparing for MQSA Inspections issued on 

May 5, 1999. 

U.S. Department Of Health and Human Services 

Food and Drug Administration 

Center for Devices and Radiological Health 

Inspection Support Branch 

Division of Mammography Quality 

and Radiation Programs 

Office of Health and Industry Programs 
Preface

Public Comment

Comments and suggestions may be submitted at any time for Agency consideration to Dockets 

Management Branch, Division of Management Systems and Policy, Office of Human Resources 

and Management Services, 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. 

For questions regarding the use or interpretation of this guidance contact Charles Gunzburg at 

301-796-5898 or email charles.gunzburg@fda.hhs.gov. 

Additional Copies 

Additional copies are available from the Internet at: http://www.fda.gov/downloads/MedicalDevices/

DeviceRegulationandGuidance/GuidanceDocuments/ucm094441.pdf, 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 (6400) to identify the 

guidance you are requesting.

The Mammography Quality Standards Act 

Final Regulations: Preparing for MQSA 

Inspections 

This document is intended to provide guidance. It represents the Agency’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 Food and Drug Administration (FDA) or the public. An 

alternative approach may be used if such approach satisfies the requirements of the 

applicable statute and regulations. 
TABLE OF CONTENTS

Background ...................................................................................................................... 1

Introduction ...................................................................................................................... 2 

Preparing for MQSA Inspections......................................................................................3 
1 

Background 

The Mammography Quality Standards Act was passed 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). The authority to approve accreditation 

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 final regulations, 

under which mammography facilities are currently regulated, became effective April 28, 1999. 

The FDA compiled all final guidance referable to MQSA into a computerized searchable Policy 

Guidance Help System in November 1998. The Policy Guidance Help System is available on 

the Internet at: www.fda.gov/cdrh/mammography/guidance-rev.html

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/cgibin/wa?SUBED1=mammography_cdrh-l&A=1 and following the directions there. 
2 

Introduction 

This document is intended to provide guidance to mammography facilities and their personnel. 

It represents the Food and Drug Administration’s (FDA) current thinking on the final regulations 

implementing the Mammography Quality Standards Act (MQSA) (Pub. L. 102-539). The FDA 

uses mandatory language, such as shall, must, and require, when referring to statutory or 

regulatory requirements. The FDA uses non-mandatory language, such as should, may, can, and 

recommend when referring to guidance. It is the responsibility of the facility to read, understand, 

and follow the final regulations. 

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 the State or 

local authorities regarding their requirements. 
3 

PREPARING FOR MQSA INSPECTIONS

This document contains an overview of the annual inspection process and is intended to help 

facilities prepare for MQSA inspections under the final regulations. It supersedes guidance 

previously issued on May 5, 1999. This guidance describes facility responsibilities and 

recommends actions that a facility may take, before an inspection, to minimize both facility 

disruption and inspection time. In large part the material has been excerpted from the Policy 

Guidance Help System provided on the internet site mentioned above which you may consult for 

more detailed information regarding the regulations. 

MQSA requires each facility conducting mammography in the United States (except those of the 

Department of Veterans Affairs) to: 

• meet quality standards for personnel, equipment, maximum allowable radiation dose, 

quality assurance, medical audit and outcome analysis, medical recordkeeping and 

reporting requirements; 

• be accredited by a Food and Drug Administration (FDA)-approved accreditation body 

(AB) (currently, the American College of Radiology [ACR] and the States of Arkansas, 

California, Iowa, and Texas); 

• be certified to perform mammography by the FDA, or an FDA approved State 

certification body (each certified facility must prominently display its certificate where it 

can be viewed by mammography patients); and 

• maintain its certified status by: 

- maintaining its accreditation, 

- having an annual survey performed by a qualified medical physicist, 

- undergoing an annual inspection conducted by an MQSA inspector , 

- paying an inspection fee (and, where applicable, re-inspection fees), and 

- correcting any deficiencies found during these processes. 

NOTE: The Centers for Medicare and Medicaid Services accepts MQSA certification as 

evidence of compliance with mammography quality standards. Only facilities with a current 

MQSA certificate will be eligible to receive Medicare/Medicaid payment for screening and 

diagnostic mammography. 

SCOPE OF THE MQSA FACILITY INSPECTION

During each inspection, MQSA inspectors assess a facility's compliance with MQSA quality 

standards. Facilities must correct all deficiencies found. Inspections will not cover any new 

regulation before its effective date. To reduce the inspection time, the scope of the standard 

inspection questions has been limited to items that FDA believes have the most direct bearing on 

facility performance and mammographic quality. However, the facility remains responsible for 

meeting all requirements of the regulations, not only those specifically listed in the inspection 

procedures. Concurrent with the MQSA inspection, States may inspect for some items that are 

required by their laws and regulations. However, these items will not affect the facility's 

compliance with MQSA or the associated MQSA inspection fee. 

Under MQSA, each facility location will be inspected at least annually for the following: 
4 

• Equipment performance 

• Quality Assurance (QA) records 

• Quality Control (QC) records and tests 

- Technologist tests 

- Medical physicist's annual survey report 

- Mammography equipment evaluations, if any 

• Personnel qualification records 

• Medical records (mammography reports and films) and lay summaries 

• Medical audit and outcome analysis records 

Mobile mammography facilities may provide services at multiple locations under the same 

certificate. Each location is recognized by FDA as a part of that facility. Each such site may be 

inspected. The scope of inspections at sites where mobile mammography activities are conducted 

will vary depending on the type of mammography services provided at each location, with or 

without the mobile x-ray system being at that location. The facility representative may request 

details regarding tests and record requirements for scheduled inspections of such sites from the 

inspector during the prior notification and scheduling process discussed below. 

PRIOR NOTIFICATION

Normally, the inspector will provide the facility with an advance notice of at least five business 

days, before an inspection. The inspector will work with the facility in scheduling the inspection 

to minimize any inconvenience to the facility. 

INSPECTION DURATION

Based on our experience, the average on-site inspection of a facility with a single x-ray unit/film 

processor combination takes between five and six hours. Approximately one hour will be 

required to evaluate the equipment with the remainder being spent reviewing facility procedures 

and records. To minimize any interference with patient care, FDA suggests that the facility 

schedule a block of time for the testing of each x-ray unit and film processor combination. To 

help minimize disruption to the facility's activities, as well as to reduce the inspection time, FDA 

recommends that the facility organize and consolidate all records the inspector will need and 

have them readily available on the day of the inspection (such records are described more fully 

below). Facility personnel may conduct their usual duties during the inspection, but should be 

available if the inspector has questions or needs assistance. 

INSPECTION PROCESS

The inspector will first meet with facility-designated representatives to verify preliminary facility 

information and to briefly outline the proposed inspection agenda. At this time, the facility staff 

should request any special sequencing of the testing and records reviews so that the facility's 

normal schedule is interrupted as little as possible. A standard annual inspection will include the 

tests and records review outlined below. After inspection, the inspector will again meet with 

facility representatives for an exit interview. 
5 

SPECIFIC INSPECTION ITEMS 

The equipment and QA/QC requirements listed in items 2 and 4 below relate to screen-film 

mammography systems. Systems using other mammographic imaging modalities are required to 

follow a quality assurance program essentially the same as that recommended by the equipment 

manufacturer. During the inspection, the inspector will verify that this requirement is met.

1. Certificate Display

Since October 1, 1994, no facility may legally perform mammography services unless it has a 

valid certificate issued under the MQSA regulations. Additionally, as described above, each such 

facility must prominently display that certificate in the facility. If a facility operates multiple 

locations under one certificate number, it may make copies of the original certificate or obtain 

additional originals from the certification authority for display at each location. 

2. Equipment Tests

FDA will inspect each x-ray system used by the facility for regulated mammography activities. 

This inspection includes equipment being leased by, loaned to, or evaluated for purchase, as well 

as equipment owned by the facility. For several of these tests, the inspector will use the facility's 

film and cassettes to ensure the applicability of the results to the facility. The inspector will also 

require assistance from facility personnel in setting up technique factors normally used by the 

facility for an average breast examination and operating the equipment, as well as any other 

preparatory work needed for each of the following elements: 

a) Determination that the equipment has been designed specifically for mammography. The 

x-ray unit satisfies this requirement as long as it meets all of the applicable MQSA 

requirements and is designated by the manufacturer and accepted by the FDA as 

appropriate for mammography. Equipment designed specifically for mammography, 

because of its unique characteristics, may also be useful for non-mammography 

procedures and such use is permitted. 

b) Determination that the system contains image receptors, moving grids, and compression 

paddles for both 18 x 24 cm and 24 x 30 cm image receptors. 

c) Confirmation that the x-ray system has a functioning post-exposure display of the actual 

x-ray focal spot and the target material used during each exposure. The display must be 

clear, legible, and visible to the operator at the unit or the operator control location. The 

actual mechanism can be achieved in any manner that provides the required information 

in an unambiguous fashion. 

d) Collimation assessment. 

e) Exposure reproducibility. 

f) Beam quality or half-value layer (HVL) measurement. 

g) Dose calculation for a cranio-caudal view of a standard breast. 

h) Processor evaluation. The regulations require that the facility set up and maintain the 

processor according to the specifications of the film manufacturer. Conformance with this 

requirement will be evaluated using the FDA's "Sensitometric Technique for Evaluation 

of Processing" (STEP) test to assess the processor performance. 
6 

i) Darkroom fog. 

j) Phantom image quality evaluation. 

NOTE: To meet item b, the facility must have at least one of each of the listed items for each 

mammography x-ray unit in the facility. There is no requirement that image receptor sizes other 

than the 18 X 24 and 24 X 30 be available for each unit in the facility. However, if a facility uses 

additional (not required by the regulations) image receptor sizes, the facility must have at least 

one moving grid and compression paddle for each such additional size. It is not necessary to 

have these items for each x-ray unit. 

3. Records Inspection

Facilities should maintain specific records regarding each regulated mammography system. 

These records cover: 

• X-ray unit accreditation status 

• Mammography equipment evaluation for new/repaired equipment 

• Annual physics survey reports (both the most recent and the previous one) 

• Evidence of post-move performance testing for mobile units 

• QC test records 

• Evidence of any corrective actions taken and subsequent verification testing 

The facility should have documentation showing that each x-ray unit has been accredited by the 

accreditation body. For a new unit, the facility must show that it has passed a mammography 

equipment evaluation prior to use on patients and that the application for accreditation of the unit 

has been submitted. For very new units (within five working days of installation), simply having 

the mammography equipment evaluation (see discussion below) and demonstrating that the 

application for accreditation is under preparation will be adequate to establish compliance. 

There are three cases where a unit in use may not need to be accredited: 

a) The unit is a "loaner," while repairs to the facility's unit are taking place, or awaiting 

delivery of a replacement unit (limited to 30 days without extenuating documentation 

from the service or dealer organization showing reasons for delay in replacement or 

repair); 

b) The unit is installed in the facility for evaluation before purchasing (limited to 90 days 

maximum without accreditation); and 

c) The unit is an experimental one, installed and used under an FDA investigative device 

exemption or other FDA-authorized research protocol. 

Note: Under both a) and b) above, the unit still must have passed a mammography equipment 

evaluation before use on patients. The above time frames and allowances are permitted under 

MQSA. Under State or local regulations and accreditation body policies, all such use may 

require registration or accreditation. Be sure to verify the requirements with these sources. 

4. Quality Assurance and Quality Control Programs

The QA program includes the designation of appropriate, qualified personnel to implement and 

oversee the QA process. These personnel must include a lead interpreting physician, medical 

physicist, and quality control technologist. The inspector will check to establish that qualified 
7 

personnel have been designated for each of these duties and that the facility has established a QA 

program, as required by the regulations, to "ensure the safety, reliability, clarity, and accuracy of 

the mammography services provided at the facility." 

Evaluation of the QA program includes the review of QA procedures and records for all of the 

requirements outlined in 21 CFR 900.12(d) and (e). Facilities are required to retain the written 

QC records for each test specified by the regulations until the next annual MQSA inspection has 

established that the facility is in compliance with the QA requirements, or until the test has been 

performed two additional times at the required frequency, whichever is longer. The time periods 

for retaining sensitometric film strips and other films produced during the tests vary and are 

described below under the individual tests. Although these records must be maintained and be 

available for review, not all records will always be evaluated during each inspection. However, 

the inspector will always seek the QA/QC information listed below: 

• Daily Processor Quality Control 

- Including actual sensitometric film strips for the previous 30 days of mammographic 

film processing and charting of the strips for the period specified above 

• Weekly Phantom Images 

- Including phantom images for the previous 90 days, and records covering the 

remainder of the retention period specified above 

• Quarterly Analysis of Fixer Retention in Film 

• Quarterly Repeat Analysis 

- Conducted quarterly, regardless of the number of films obtained in the quarter, and 

should include all repeated and rejected clinical films obtained in the quarter. Large 

volume facilities may limit the analysis to those films collected after a minimum of 

250 patient examinations. 

• Semiannual Darkroom Fog 

- QC records and test strips must be retained for the period specified above 

• Semiannual Screen-Film Contact 

- QC records and images from screen-film contact for the retention period specified 

above 

• Semiannual Compression 

• Personnel responsibilities and procedures for QA/QC testing. Records must be kept 

indefinitely. 

• Other QA-related written policies, procedures, and records required by the regulations 

such as those relating to infection control, breast implants, and consumer complaints. 

Records must be kept indefinitely. 

• Mammographic technique charts, and information pertinent to optimizing 

mammographic quality should also be available for inspection. Records should be kept 

indefinitely. 

In general, the facility's QC records should show that all MQSA required tests were: 

• conducted at the frequencies specified in the regulations (as a minimum), and 

• followed by timely and effective corrective actions that were shown to be necessary 

(documentation of any corrective action is required). 

Note regarding the Interpretation of Test Frequencies: In the past, some facilities have 

interpreted the words "weekly," "quarterly," and "semi-annually" in ways different from that 
8 

intended by FDA. Since October 1, 1999, FDA has interpreted the regulatory requirements for 

test frequencies as follows: 

• Weekly Phantom Image Test: Must be performed each week in which mammograms are 

performed. However, the test need not be performed on the same day each week. 

• Quarterly Tests: Must be performed 4 times a year or at a minimum once in each 3 month 

period in which mammograms are performed. The 4 months that are chosen must be 

spaced 3 months apart (such as February, May, August, and November.) However, for 

any of the 4 selected months, each test may be performed on any day (not necessarily the 

same day) in the month. 

• Semi-annual Tests: Must be performed 2 times a year or at a minimum once in each 6 

month period in which mammograms are performed. The 2 months that are chosen must 

be spaced 6 months apart (such as January and July). However, for any of the 2 selected 

months, each test may be performed on any day (not necessarily the same day) in the 

month. 

For listing of the required QC test items, required frequencies, and examples of acceptable 

documentation, see Attachments 2 and 3. The items appearing in Attachment 2 must be 

performed more frequently than the annual tests in Attachment 3 and will normally fall under the 

responsibility of the quality control technologist. Although the annual tests may be conducted 

more frequently than annually, they must be conducted by a MQSA-qualified medical physicist 

(or someone in training under his or her direct supervision) when performed as part of the annual 

survey or a mammography equipment evaluation. The results of the annual tests and any 

recommendations for corrective actions must be stated in the medical physicist's survey report. 

5. Medical Physicist's Survey Report

Each facility must undergo “at least once each year” a survey performed by a medical physicist. 

For various reasons it is often impractical for these annual surveys to be conducted exactly on the 

anniversary of the previous survey, therefore FDA will accept a range of 10 to 14 months since 

the previous survey as being adequate to satisfy the “at least once each year” requirement stated 

in the regulations. The facility must have available for the inspector the two most recent annual 

physicist survey reports. The reports must document the physicist's tests, the results, the 

evaluation of the technologist's QC testing, and include recommendations for any corrective 

actions resulting from the tests or review. The facility should also have evidence of its actions 

concerning each recommendation. 

6. Mammography Equipment Evaluation

When a new or an existing mammography facility obtains new mammographic equipment or 

processors, it must pass a mammography equipment evaluation conducted by a qualified medical 

physicist before such equipment is placed into service. In this context, "new" means new to the 

facility and may be previously used equipment. In addition, a medical physicist must perform a 

mammography equipment evaluation whenever such equipment is disassembled and then 

reassembled, either at the same or a new location, or whenever a major component is changed or 

repaired. The inspector will verify that appropriate records are available to document compliance 

with this requirement. 
9 

The medical physicist must provide the facility with sufficient documentation to clarify the 

testing performed and the results of the testing. All problems must be corrected, and the 

corrections documented, before the new or changed equipment is put into clinical service. 

7. Personnel Qualifications

The facility is required to maintain records documenting initial and continuing qualifications of 

all personnel who have performed or are performing the duties of interpreting physician, 

radiological technologist, or medical physicist, and all employees assigned to quality assurance 

tasks for the facility. Facilities are to ensure that new mammography personnel meet all 

applicable requirements prior to allowing them to provide mammography services. This 

requirement covers records for individuals who provide or have provided temporary and/or 

contract services for the facility, including personnel who may provide services offsite. Once an 

employee leaves, the facility is not expected to continue tracking their status. If personnel leave, 

the facility is expected to maintain their records until the next annual MQSA inspection has been 

completed and FDA has determined that the facility complies with all MQSA personnel 

requirements. 

Facilities should be aware that their State(s) might have more stringent recordkeeping 

requirements. Check with your State(s) before making any final decisions regarding the 

disposition of any records. 

The required personnel information is listed below and must be available for the inspector's 

review during the inspection. 

Interpreting Physicians

Interpreting physicians initially qualifying on or after the April 28, 1999 effective date of the 

final regulations, must meet all of the following requirements. Physicians who qualified under 

FDA's interim regulations (prior to April 28,1999) are considered to have met the initial 

requirements listed in items 2 through 4 below. They may continue to interpret mammograms if 

they continue to meet the licensure requirement in item 1, the new modality training requirement 

for item 5 (if applicable), and the continuing experience and continuing education requirements 

for items 6 and 7. 

1. Licensure: Be licensed to practice medicine in a State. 

AND

2. a. Board Certification: Be certified in radiology or diagnostic radiology by any of the 

following bodies: 

• The American Board of Radiology (ABR) 

• The American Osteopathic Board of Radiology (AOBR) 

• The Royal College of Physicians and Surgeons of Canada (RCPSC) 

OR

b. Initial Training: Have had at least 3 months of documented formal training in the 

interpretation of mammograms and in topics related to mammography (to include 
10 

instruction in radiation physics, including radiation physics specific to mammography, 

radiation effects, and radiation protection). 

AND

3. Initial Category I Education: Have a minimum of 60 hours of documented category I 

medical education in mammography (including instruction in the interpretation of 

mammograms and education in basic breast anatomy, pathology, physiology, technical 

aspects of mammography, and quality assurance and quality control in mammography). 

At least 15 of the required 60 hours must have been acquired within the 3 years 

immediately before the physician's initial qualification date. These 60 hours may be 

included in the 3 months of training specified in 2.b above. Hours received in residency 

training are considered equivalent to category I. 

AND

4. Initial Experience: Have interpreted or multi-read, under direct supervision of a 

qualified interpreting physician, at least 240 mammographic examinations within the 6-

month period immediately before the date that the physician qualifies as an interpreting 

physician (or in any 6-month period during the last 2 years of a diagnostic radiology 

residency for physicians who become appropriately board certified at the first allowable 

time, as defined by the board). 

AND

5. New Mammographic Modality: Before an interpreting physician may begin 

independently interpreting mammograms produced by any mammographic modality in 

which the interpreting physician was not previously trained (e.g., xeromammography, 

digital mammography, screen-film mammography), the physician must have at least 8 

hours of training in that mammographic modality. 

AND

6. Continuing Experience: Have interpreted or multi-read at least 960 mammographic 

examinations 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 beginning date for meeting the continuing experience requirement is the later of 

October 1, 1994, or the individual's actual starting date (the date on which an individual 

met all applicable requirement to begin independently providing mammography 

services). Failure to meet the continuing experience requirement will not be considered a 

noncompliance until at least 24 months after the individual's starting date.

AND

7. Continuing Education: Have taught or completed at least 15 category I continuing 

medical education (CME) credits in 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. CME credits 

earned through teaching a course can be counted only once toward meeting the 15 credits 

required in any 36-month period. Such training shall include at least 6 credits of category 

I CME in each mammographic modality used by the interpreting physician. 
11 

The beginning date for meeting the continuing education requirement is the later of 

October 1, 1994, or the individual's actual starting date (the date on which an individual 

met all applicable requirement to begin independently providing mammography 

services). Failure to meet the continuing education requirement will not be considered a 

noncompliance until at least 36 months after the individual's starting date.

FDA permits multi-reading/interpreting of mammograms and summing of 

readings/interpretations from different facilities in calculating the total mammographic 

examinations for items 4 and 6 above. Multi-reading is defined as two or more physicians, at 

least one of whom is a fully qualified interpreting physician, interpreting the same mammogram. 

Multi-reading includes reading comparison mammograms not previously read by the physician. 

So that facilities are aware of potential problems, FDA recommends that facilities update 

education and experience records at least quarterly. 

Specific information on acceptable documentation for the interpreting physician's qualifications 

is listed in Attachment 4. 

Radiologic Technologist

Radiologic technologists initially qualifying on or after the April 28,1999 effective date of the 

final regulations must meet all of the following requirements. Radiologic technologists, who 

qualified under FDA's interim regulations (before April 28,1999) are considered to have met the 

initial training requirements listed in item 2 below. They may continue to perform mammograms 

if they continue to meet the licensure or certification requirements of item 1, any applicable new 

modality training requirement from item 3, and the continuing experience and education 

requirements of items 4 and 5. 

1. a. Licensure: Have a general/full license to perform radiographic procedures issued by 

a State. 

OR

b. Board Certification: Be certified by either of the following bodies: 

• The American Registry of Radiologic Technologists (ARRT) 

• The American Registry of Clinical Radiography Technologists (ARCRT) 

AND

2. Initial Training in Mammography: Have at least 40 contact hours of mammography 

training, including breast anatomy, physiology, positioning, compression, quality 

assurance/quality control techniques, imaging of patients with breast implants, and the 

performance of 25 supervised examinations. The actual time spent performing supervised 

examinations may be included in the 40 hour total. As guidance, however, no more than 

12.5 hours of the required 40 should come from the performance of examinations. 

AND

3. New Mammographic Modality: Before a radiologic technologist may independently 

perform mammographic examinations using any mammographic modality in which the 

radiologic technologist was not previously trained (e.g., xeromammography, digital 
12 

mammography, screen-film mammography), the radiologic technologist must have at 

least 8 hours of training in the modality. 

AND

4. Continuing Experience: Have performed a minimum of 200 mammography 

examinations 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 beginning date for meeting this requirement is April 28, 1999, or the individual’s 

actual starting date (date on which the individual initially qualifies to work 

independently), whichever is later. Failure to meet the technologist's continuing 

experience requirement will not be considered a noncompliance until the later of July 1, 

2001, or at least 24 months after the technologist's starting date.

AND

5. Continuing Education: Have taught or completed at least 15 continuing education units 

in 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. At least 6 of these CEUs must be in each of the 

mammographic modalities used by the technologist. CEUs earned through teaching a 

course can be counted only once towards meeting the units required in any 36-month 

period. 

The beginning date for meeting the continuing education requirements is the later of 

October 1, 1994, or the individual’s actual starting date (date on which the individual 

initially qualifies to work independently), whichever is later. Failure to meet the 

continuing education requirements will not be considered a noncompliance until at least 

36 months after the technologist's starting date.

As with the physicians, FDA recommends that the facilities update the education and experience 

records at least quarterly. 

Specific information on acceptable documentation for the technologist's qualifications is listed in 

Attachment 5. 

Medical Physicist

There are no "grandparenting" provisions in the final MQSA regulations covering the medical 

physicist, and ALL physicists qualified prior to April 28, 1999, have additional criteria for 

qualification under the final regulations. 

The qualifications for the medical physicist are relatively complicated. 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 "master's 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 
13 

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 "master's 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 at least a master's degree or higher in a physical science with at 

least 20 semester hours (30 quarter hours) of graduate or undergraduate 

physics. 

AND

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 1 

mammography facility and 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 have 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) 

i. The American Board of Medical Physics (ABMP) 

AND
14 

2. Education, training, and experience: 

a. Degree: Have a bachelor's 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

c. Initial Experience: Have the experience of conducting surveys of at least 1 

mammography facility and 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 mammography 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

2. Continuing Experience: The physicist must have conducted a minimum of two 

mammography facility surveys and a total of six mammography unit surveys (or

mammography 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 beginning date for this requirement is April 28, 1999 or the individual’s 

actual starting date (date on which the physicist initially qualifies to work 

independently), whichever is later. Failure to meet the physicist's continuing 

experience requirement will not be considered a noncompliance until the later of 

July 1, 2001 or at least 24 months after the physicist's 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. The continuing education must include more than 1 unit in each 

mammographic modality evaluated by the medical physicist. CEUs earned 

through teaching a course can be counted only once toward meeting the 15 units 

required in any 36-month period. 
15 

The beginning date for this requirement is October 1, 1994, or the individual’s 

actual starting date (date on which the physicist initially qualifies to work 

independently), whichever is later. Failure to meet the physicist's continuing 

education requirement will not be considered a noncompliance until at least 36 

months after the physicist's 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 

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. 

Specific information on acceptable documentation for the physicist's qualifications is listed in 

Attachment 6. 

All Personnel - Attestation

FDA allows personnel to attest to certain training, education, or experience earned before 

October 1, 1994. Physician initial 2 or 3 months training and medical physicist degree 

requirements, including the required number of hours in physics, cannot be attested to at any 

time. In general, FDA does not intend to accept attestation for training, education, or experience 

obtained after October 1, 1994. However, FDA will accept a limited form of attestation for 

CME/CEUs earned after October 1, 1994, if a continuing education provider does not 

specifically document the number of hours earned in mammography. Such attestation will be 

acceptable if it includes documentation showing both the total number of CME/CEUs earned in 

the program and the total number of CME/CEUs specific to mammography that were available. 

If the meeting or other educational opportunity is limited to mammography, then only 

documentation from the provider of the number of CME/CEUs earned is needed (no attestation 

is required in this instance). 

In certain situations, attestation will also be accepted for meeting the “new mammographic 

modality” requirement. Specifically, personnel who worked with investigational full field digital 

mammography systems prior to April 28, 1999, may attest to that experience. In addition, 

personnel who received mammography modality specific training prior to October 1, 1994 may 

attest to that training. All attestations must be in the proper format. (An attestation form is 

included as Attachment 1.) 

8. Medical Records

Patient Permanent Records

Medical records must contain certain required types of information. To ensure that both the 

mammographic images and reports are being retained as required, and to verify they contain the 

information outlined below, the inspector will randomly select records for review. In general, the 

inspector will request reports from those examinations performed since the last MQSA 

inspection, or since the facility's certification, whichever is the most recent. However, inspectors 

may examine records from other time frames. The inspector will not attempt to assess the 

correctness of these reports, but will determine that the records are being generated, properly 
16 

maintained, and identify the interpreting physician who originally interpreted the mammograms. 

For those mammography medical reports created on or after April 28, 1999, the inspector will 

also verify that one of the following assessment categories appears in each: "Negative," 

"Benign," "Probably Benign," "Suspicious," "Highly suggestive of malignancy," or "Incomplete: 

Need additional imaging evaluation." 

The facility is required to communicate the results, within 30 days of the examination, to the 

referring health care provider and to the patient (lay summary). In the case of self-referred 

patients, if a health care provider (or a responsible designee) is not named or is unavailable, then 

the report must be provided to the patient. Communications to the patient, if there is no health 

care provider, must include 1) the complete report of findings referenced above and 2) the 

summary written in lay terms that is required for all patients. When the assessment is 

"Suspicious" or "Highly suggestive of malignancy," the facility is required to communicate the 

results, as soon as possible, to the referring health care provider and to the patient (lay summary) 

and depending on health care provider availability, may need to send the complete report to the 

patient). Facility personnel should be prepared to explain the facility's procedure for 

communicating results to referring physicians and to patients and their mechanism for providing 

quick response for cases requiring such action. 

FDA's concern is not the details of the communication system but rather: 

• that one has been established by the facility, 

• that it is in place, and 

• that it meets the requirements of the regulations. 

The inspector will verify that the communication system meets these criteria and that lay 

summaries are available. If patient records are stored in an electronic format, the inspector will 

ask the facility to assist in the selection and retrieval of the records to be inspected. 

9. Mammography Medical Audit and Outcomes Analysis

Each facility must establish and maintain a system to track positive mammographic findings and 

to correlate such findings with the biopsy results the facility obtains on an annual basis. 

At a minimum, the system must track "positive mammographic findings," which refers to 

mammograms interpreted as "Suspicious" or " Highly suggestive of malignancy." MQSA leaves 

it up to each facility to use a tracking system that works best for it. This system must include a 

set of procedures to track mammograms, determine whether biopsies were done on the patient, 

determine (at a minimum) whether the biopsy specimen was benign or malignant, and report this 

information back to the interpreting physician. The system may be manual or computerized. 

Facilities must also include in their audit any patients that they become aware of who were 

subsequently found to have cancer that was not detected through their mammogram. The audit 

analysis must be initiated within 12 months after the date the facility becomes certified. The 

audit analysis must then be completed within an additional 12 months with subsequent audit 

analyses to be conducted at least once every 12 months. The analyses are to be reviewed by an 

"audit interpreting physician" appointed by the facility. The "audit interpreting physician" has 

multiple responsibilities listed in 900.12(f)(3) that must be covered in the facility's audit 

program. 
17 

The inspector will examine the audit system for the inclusion of the above items, ascertain how 

biopsy results are obtained, and request to see examples of biopsy results that the facility has 

obtained. If biopsies were recommended but no results were obtained, the facility must provide 

documentation of attempts to get this information. 

REPEAT FINDINGS

If a facility inspection finds "repeat" problems (deficiencies of the same type, either recurring or 

never corrected, found during the previous inspection), the post-inspection report provided to the 

facility will identify which findings have been repeated. Depending on their seriousness, these 

repeat deficiencies could result in the requirement of a written response from the facility, a 

follow-up inspection, and/or sanctions against the facility. 

MOBILE MAMMOGRAPHY

The QC for x-ray units used for mobile mammographic purposes must meet all of the 

requirements applicable to stationary mammography x-ray units plus the additional requirement 

of post-move, pre-clinical use performance testing. This additional test is to ensure the 

satisfactory performance of the unit after each move and before patients are imaged. The 

following are examples of acceptable tests: 

• A phantom image can be taken in the AEC mode (or the mode used clinically) after the 

move but prior to patient examination. This image is then either processed and evaluated 

at the mobile unit site (if possible), or processed off-site and evaluated to verify 

performance prior to examining patients. A passing score for this phantom image verifies 

that the unit is performing adequately after moving and before patient examination. 

• Another example is to (1) for a given kVp, record the mAs resulting from a phantom 

exposure (in the AEC mode under typical clinical conditions or the mode used clinically); 

(2) compare that mAs to a standard mAs value previously established as ensuring output 

consistency; and (3) if the two readings are within +/- 10%, proceed with clinical 

examinations; otherwise take corrective actions to bring the two values within this limit 

before proceeding with clinical examinations. A crucial follow-up to this test by the 

facility is to process (using a processor in control) and score the phantom image taken in 

step (1) at the earliest time available and before batch processing any of the clinical 

images. If this phantom fails because of any processing problems, the problems should 

be corrected prior to processing any of the clinical images. If the phantom image fails 

due to a non-processor problem, the mobile facility should still process all the films. 

Each clinical exam should be evaluated individually to determine whether any of the 

patients have to be recalled to have their images repeated. The entire imaging chain must 

be checked and adjusted or repaired prior to further clinical use. 

• If the facility takes a phantom image as part of its post-move/pre-examination testing, it 

must document the phantom image score. The facility must keep the written records of 

post-move/pre-examination tests for the last 12 months or since the last inspection, 

whichever is longer, and the phantom images for the last 30 days. 

• Other tests designed by qualified personnel (the medical physicist should be consulted) 

could be acceptable but may have to be evaluated by the inspector on a case-by-case 

basis. If a facility has any questions regarding the acceptability of such alternative 
18 

measures, they should obtain a ruling from FDA on the alternative before relying on such 

testing. 

EXIT INTERVIEW 

During the exit interview with facility personnel, the inspector will review the results of the 

inspection and either leave a summary of findings or mail this summary to the facility within two 

weeks. 

If major deficiencies are found, the facility will receive a letter, addressed to the facility's 

"Responsible Person," concerning these issues. The facility's "Responsible Person" is a person 

the facility has identified as having the authority to make vital operational and financial decisions 

concerning corrective actions that are required to bring the facility into compliance. All 

deficiencies should be corrected as soon as possible. Depending on the level of the severity of 

the problems, specific regulatory mandated time frames will be included in the letter. The 

facility is required [21 CFR 900.12(e)(8)(ii)(A)] to correct problems found with the 

following areas of the QC program "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 - 900.12(e)(1), 

- base plus fog 

- mid-density 

- density difference 

• Weekly QC tests - 900.12(e)(2) 

- phantom image quality 

• Semiannual QC tests - 900.12(e)(4) 

- Darkroom fog - 900.12(e)(4)(i) 

- Screen-film contact - 900.12 (e)(4)(ii) 

- Compression device performance - 900.12 (e)(4)(iii)

• Annual QC tests - 900.12(e)(5) 

- Dose - 900.12(e)(5)(vi)

• Other modalities - 900.12(e)(6) 

• Mobile units - 900.12(e)(7) 

For violations related to the quality control (QC) tests described in paragraph 900.12(e)(8)(ii)(B), 

the facility must complete repairs within 30 days of discovering the problem. Facilities 

continuing to operate under deficient conditions could be subject to sanctions. Such sanctions 

could include a directed plan of correction, civil money penalties, or certificate suspension or 

revocation. Certain findings could also require a follow-up inspection to verify correction. 

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. 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. 
19 

Attachment 1 

ATTESTATION FORM 

Regarding Requirements of the Mammography Quality Standards Act 

Attestation must 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. 

____________________________________________________________________________ 

Attestor'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) 
20 

Attachment 2 

Quality Control Tests Other than Annual 

Test & 

Frequency 

Requirements for 

Acceptable Operation 

Guidance for Acceptable 

Documentation Retention* 

Timing of Required 

Corrective Action ** 

Processor 

QCDaily 

Established operating level 

for B+F, + up to 0.03 OD. 

QC records (&charts) for the last 12 

months or since the last inspection, 

whichever is longer. 

QC test films for the last 30 days. 

Before any further clinical 

films are processed. 

" Established operating level 

for MD, ± 0.15 OD. 

" " 

" Established operating level 

for DD, ± 0.15 OD. 

" " 

Phantom QCWeekly Established operating level 

for OD at center of image 

≥1.2 ± 0.20, but the 

minimum OD must be ≥ 1.2 

at any time. 

QC records for the last 12 months or 

since the last inspection, whichever 

is longer. Phantom images for the 

last 90 days. 

Before any further 

examinations are performed 

using the x-ray machine. 

" Established operating level 

for contrast, ± 0.05 OD 

" " 

" Minimum score of 4 fibers, 3 

speck groups, 3 masses. 

" " 

Fixer retention in 

filmQuarterly 

< 5 micrograms per square 

cm of residual fixer. 

QC Records since the last 

inspection or for the past three tests, 

whichever is longer. 

Within 30 days of the date of 

the test. 

Repeat AnalysisQuarterly Operating level for repeat or 

reject rate is < 2% change (up 

or down) from previous rate. 

" " 

Darkroom FogSemi-annually 

OD ≤ 0.05. QC Records since last inspection or 

for the past three tests, whichever is 

longer. Fog QC films from the 

previous three tests. 

Before any further clinical 

films are processed. 

Screen-Film 

ContactSemi-annually 

All mammography cassettes 

used must be tested with a 

40-mesh copper screen. 

QC records since last inspection or 

for the past three tests, whichever is 

longer. S-F contact QC films from 

the previous three tests. 

Before any further 

examinations are performed 

using the cassettes. 

Compression 

Device 

Semi-annually 

Compression force ≥ 111 

newtons (25 pounds). 

Effective 10/28/2002, initial 

power drive maximum 

compression force between 

111 and 200 newtons (25 and 

45 pounds). 

QC records since last inspection or 

for the past three tests, whichever is 

longer. 

Before examinations are 

performed using the 

compression device. 

* Guidance regarding the length of time for which the facility is required to keep QC records was given earlier under 

900.12(d)(2). 

** Refer to 900.12(e)(8)(ii)(A) or (B) as applicable.
21 

Attachment 3 

Annual Quality Control Tests 

Test Scope Regulatory Action Levels Timing of required 

corrective action* 

AEC 

Performance 

Capability 

All x-ray units. 

Thickness tracking (2-6 cm, 

appropriate kVp’s). 

kVp Tracking (clinic. range). 

OD exceeds the mean by more than 

± 0.30 (over 2-6 cm thickness range) 

[± 0.15 after 10/28/2002]. 

Phantom image OD at center < 1.20. 

Within 30 days after test 

failure. 

kVp Accuracy & 

Reproducibility 

All x-ray units. kVp accuracy outside ± 5% of 

indicated /selected kVp. 

Reproducibility COV > 0.02. 

“ 

Focal 

spot/System 

Resolution 

All x-ray units, all clinically used 

target materials and focal spots 

1) Spot size measurement until 

10/28/02 @ the most used SID 

2) Resolution measurement 

Same as 1) but if mag mode is 

used, then test at SID w/mag 

value closest to 1.5 obtainable 

(used clinically or not) & for all 

clinically used mag screen-film 

combinations 

See focal spot table in the regs. 

11 cycles/mm with bars 

perpendicular to anode-cathode axis. 

13 cycles/mm with bars parallel to 

anode-cathode axis. 

“ 

HVL All x-ray units. 

All clinically used target/filter 

combinations. 

See HVL table in regulations. “ 

Air Kerma & 

AEC 

Reproducibility 

All x-ray units. Reproducibility COV for each 

exceeds 0.05. 

“ 

Dose All x-ray units. 

All targets/filter combos used for 

the Standard Breast. 

Exceeds 3.0 mGy (0.3 rad) per 

exposure (for the Standard Breast). 

Before any further 

examinations are 

performed. 

Phantom 

Image** 

All x-ray units < 4 fibers, 3 speck groups, 3 masses “ 

X-ray field/light 

field 

X-ray field/IR 

Compression 

device/IR 

All x-ray units. 

All combinations of collimators, 

image receptor sizes, targets & 

focal spots clinically used in full 

field imaging of the breast. 

X-ray/light field: > 2% SID 

X-ray field/IR: Outside IR: > 2% 

SID (all sides.) Inside IR: less than 

full coverage at cw. Comp. 

device/IR: Outside IR:>1%SID 

Inside IR: Paddle visible on image 

Within 30 days of the 

date of discovery. 

Screen Speed 

Uniformity 

All cassettes – sub-grouping 

allowed. 

O.D. variation exceeds 0.30 from 

highest to lowest. 

" 

System Artifacts All x-ray units and processors, 

all cassette sizes, all clinically 

used focal spots & target/filter 

combinations. 

Determined by physicist. " 

Radiation Output All x-ray units. Output < 4.5 mGy/sec (513 mR/sec), 

and < (7 & 800) after 10/28/2002 

" 

Decompression All x-ray units (if auto 

decompression is provided). 

Failure of override mechanism, 

manual release, or status indicator. 

" 

Any applicable 

annual new 

modality tests 

All x-ray units. Depends on test. Before clinical use. 

* Refer to 900.12(e)(8)(ii)(A) or (B) as applicable. 

** This is the same as the weekly phantom image test but it must also be performed annually by the medical physicist.
22 

Attachment 4 

Acceptable Documents For Interpreting Physicians

Requirement Obtained Prior to 10/1/94 Obtained 10/1/94-4/28/99 Obtained after 4/28/99 

State License 1. State license/copy with 

expiration date 

2. Confirming letter from 

State licensing board 

3. Pocket card/copy of license 

1. State license/copy with 

expiration date 

2. Confirming letter from 

State licensing board 

3. Pocket card/copy of license 

1. State license/copy with 

expiration date 

2. Confirming letter from State 

licensing board 

3. Pocket card/copy of license 

Board Certification 

(ABR, AOBR, or RCPSC) 

1. Original/copy of certificate 

2. Confirming letter from 

certifying board 

3. Confirming letter from 

ACR 

4. Listing in ABMS directory 

1. Original/copy of certificate 

2. Confirming letter from 

certifying board 

3. Confirming letter from 

ACR 

4. Listing in ABMS directory 

1. Original/copy of certificate 

2. Confirming letter from 

certifying board 

3. Confirming letter from 

ACR 

4. Listing in ABMS directory 

Formal Training 

(2 months-interim regs) 

(3 months-final regs) 

1. Letters or other documents 

from US or Canadian 

residency programs 

2. Documentation of formal 

mammography training 

courses 

3. Category I CME certificates 

1. Letters or other documents 

from US or Canadian 

residency programs 

2. Documentation of formal 

mammography training 

courses 

3. Category I CME certificates 

1. Letters or other documents 

from US or Canadian 

residency programs 

2. Documentation of formal 

mammography training 

courses 

3. Category I CME certificates 

Initial Medical Education 

(40 hours-interim regs) 

(60 hours/15 in last 3 yearsfinal regs) 

1. Attestation 

2. Letter from residency 

program 

3. CME certificates 

4. Letter or other document 

confirming in-house or 

formal training 

1. Letter from residency 

program 

2. CME certificates 

3. Letter or other document 

confirming in-house or 

formal training 

1. Letter from residency 

program 

2. CME certificates 

3. Letter or other document 

confirming in-house or 

formal training (Category I) 

Initial Experience (240) 

(any 6 month period-interim 

regs) 

(last 6 month vs 6 month in last 

2 years of residency-final 

regs) 

1. Attestation 

2. Letter or other document 

from residency or training 

program or mammography 

facility 

1. Letter or other document 

from residency or training 

program or mammography 

facility – done under direct 

supervision 

1. Letter or other document 

from residency or training 

program or mammography 

facility – done under direct 

supervision 

Initial Mammographic 

Modality Specific Training8 hours-final regs 

1. Attestation for training or 

experience with 

investigational units 

2. Mammography Modality 

Specific CME certificates 

(Category I or II) 

3. CME certificates (Category 

I or II) plus agenda, course 

outline or syllabus 

4. Confirming letters from 

CME granting 

organizations 

5. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 

6. Letter from facility where 

experience was obtained 

documenting experience in 

the new mammographic 

modality 

1. Attestation for experience 

with investigational units 

2. Mammography Modality 

Specific CME certificates 

(Category I or II) 

3. CME certificates (Category 

I or II) plus agenda, course 

outline or syllabus 

4. Confirming letters from 

CME granting organizations 

5. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 

6. Letter from facility where 

experience was obtained 

documenting experience in 

the new mammographic 

modality 

1. Mammography Modality 

Specific CME certificates 

(Category I or II) 

2. CME certificates (Category 

I or II) plus agenda, course 

outline or syllabus 

3. Confirming letters from 

CME granting 

organizations 

4. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 
23 

Continuing Experience (960/24 

months) 

N/A 1. Letter, table, facility logs or 

other documentation from 

residency or training 

program or mammography 

facility 

1. Letter, table, facility logs or 

other documentation from 

residency or training 

program or mammography 

facility 

Continuing Education (15 

CME/36 months-interim 

regs) 

(15 Category I CME/36 

months-final regs) 

N/A 1. CME certificates (Category 

I or II) 

2. Confirming letters from 

CME granting 

organizations 

3. Letters, certificates or other 

documents from 

manufacturers’ training 

courses 

1. CME certificates (Category 

I) 

2. Confirming letters from 

CME granting 

organizations 

Continuing Mammographic 

Modality Specific 

Education-final regs 

N/A 1. Mammography Modality 

Specific CME certificates 

(Category I or II) 

2. CME certificates (Category 

I or II) plus agenda, course 

outline or syllabus 

3. Confirming letters from 

CME granting 

organizations 

4. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 

1. Mammography Modality 

Specific CME certificates 

(Category I) 

2. CME certificates (Category 

I) plus agenda, course 

outline or syllabus 

3. Confirming letters from 

CME granting 

organizations 

Requalification-Experience–

done under direct 

supervision 

N/A 1. Letter, table, facility logs or 

other documentation from 

residency or training 

program or mammography 

facility 

1. Letter, table, facility logs or 

other documentation from 

residency or training 

program or mammography 

facility 

Requalification- Education N/A 1. CME certificates (Category 

I or II) 

2. Confirming letters from 

CME granting 

organizations 

1. CME certificates (Category 

I) 

2. Confirming letters from 

CME granting 

organizations 
24 

Attachment 5 

Acceptable Documents For Radiologic Technologists 

Requirement Obtained Prior to 10/1/94 Obtained 10/1/94-4/28/99 Obtained after 4/28/99 

State Licensure 1. State license/copy with 

expiration date 

2. Confirming letter from State 

licensing board 

3. Pocket card/copy of license 

1. State license/copy with 

expiration date 

2. Confirming letter from State 

licensing board 

3. Pocket card/copy of license 

1. State license/copy with 

expiration date 

2. Confirming letter from State 

licensing board 

3. Pocket card/copy of license 

Board Certification 

(ARRT or ARCRT) 

1. Original/copy of current 

certificate 

2. Confirming letter from 

certifying board 

3. Pocket card/copy of 

certificate 

1. Original/copy of current 

certificate 

2. Confirming letter from 

certifying board 

3. Pocket card/copy of 

certificate 

1. Original/copy of current 

certificate 

2. Confirming letter from 

certifying board 

3. Pocket card/copy of 

certificate 

Initial Training 

(~40 hours-interim regs) 

(40 hours-25 supervised 

exams-final regs) 

1. Attestation 

2. Letter or other document 

from training program 

3. CEU certificates 

4. Letter or other document 

confirming in-house or 

formal training 

5. ARRT(M) Mammography 

certificate 

6. California Mammography 

certificate 

7. Arizona Mammography 

certificate 

8. Nevada Mammography 

certificate 

1. Letter or other document 

from training program 

2. CEU certificates 

3. Letter or other document 

confirming in-house or 

formal training 

4. Approved RT training 

courses 

5. ARRT(M) Mammography 

certificate 

6. California Mammography 

certificate 

7. Arizona Mammography 

certificate 

8. Nevada Mammography 

certificate

1. Letter or other document 

from training program 

2. CEU certificates 

3. Letter or other document 

confirming in-house or 

formal training 

Initial Mammography Modality 

Specific training-8 hoursfinal regs 

1. Attestation for training or 

experience with 

investigational units 

2. Mammography Modality 

Specific CEU certificates 

3. CEU certificates plus 

agenda, course outline or 

syllabus 

4. Confirming letters from 

CEU granting organizations 

5. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 

6. Letter from facility where 

experience was obtained 

documenting experience in 

the new mammographic 

modality 

1. Attestation for experience 

with investigational units 

2. Mammography Modality 

Specific CEU certificates 

3. CEU certificates plus 

agenda, course outline or 

syllabus 

4. Confirming letters from 

CEU granting organizations 

5. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 

6. Letter from facility where 

experience was obtained 

documenting experience in 

the new mammographic 

modality 

1. Mammography Modality 

Specific CEU certificates 

2. CEU certificates plus 

agenda, course outline or 

syllabus 

3. Confirming letters from 

CEU granting organizations 

4. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 

Continuing Experience 

(200/24 months-final regs) 

N/A N/A 1. Letter, table, facility logs or 

other documentation from 

training program or 

mammography facility 
25 

Continuing Education (15 

CME/36 months) 

N/A 1. CEU certificates 

2. Confirming letters from 

CEU granting organizations 

3. Formal training courses 

4. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 

1. CEU certificates 

2. Confirming letters from 

CEU granting organizations 

3. Formal training courses 

4. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 

Continuing Mammographic 

Modality Specific 

Education-final regs 

N/A 1. Mammography Modality 

Specific CEU certificates 

2. CEU certificates (plus 

agenda, course outline or 

syllabus 

3. Confirming letters from 

CEU granting organizations 

4. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 

1. Mammography Modality 

Specific CEU certificates 

2. CEU certificates (plus 

agenda, course outline or 

syllabus 

3. Confirming letters from 

CEU granting organizations 

4. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 

Requalification-Experience–

final regs–done under direct 

supervision 

N/A N/A 1. Letter, table, facility logs or 

other documentation from 

training program or 

mammography facility 

(done under direct 

supervision) 

Requalification- Education N/A 1. CEU certificates 

2. Confirming letters from 

CEU granting organizations 

3. Letter or other document 

confirming in-house or 

formal training 

4. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 

1. CEU certificates 

2. Confirming letters from 

CEU granting organizations 

3. Letter or other document 

confirming in-house or 

formal training 

4. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 
26 

Attachment 6 

Acceptable Documents For Medical Physicists

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 expiration date 

2. Confirming letter from State 

licensing board 

3. FDA Approval Letter 

1. State license or approval/copy 

with expiration date 

2. Confirming letter from State 

licensing board 

3. FDA Approval Letter 

1. State license or approval/copy 

with expiration date 

2. Confirming letter from State 

licensing board 

3. FDA Approval Letter 

Board Certification 

(ABR or ABMP) 

1. Original/copy of certificate 

2. Confirming letter from 

certifying board 

3. Pocket card/copy of certificate 

4. Confirming letter from ACR 

5. FDA Approval Letter 

1. Original/copy of certificate 

2. Confirming letter from 

certifying board 

3. Pocket card/copy of 

certificate 

4. Confirming letter from ACR 

5. FDA Approval Letter 

1. Original/copy of certificate 

2. Confirming letter from 

certifying board 

3. Pocket card/copy of 

certificate 

4. Confirming letter from ACR 

5. FDA Approval Letter 

Degree in a physical sciencefinal regs 

(Master’s pathway) 

(Bachelor’s pathway) 

1. Original/copy of diploma 

2. Confirming letter from college 

or university 

3. FDA Approval Letter 

1. Original/copy of diploma 

2. Confirming letter from 

college or university 

3. FDA Approval Letter 

1. Original/copy of diploma 

2. Confirming letter from 

college or university 

3. FDA Approval Letter 

Initial physics education-final 

regs 

(20 semester hours-Master) 

(10 semester hours-Bachelor) 

1. College or university transcripts 

2. Confirming letter from college 

or university 

3. Master or Bachelor degree

specifically in physics 

4. FDA Approval Letter 

1. College or university 

transcripts 

2. Confirming letter from 

college or university 

3. Master or Bachelor degree

specifically in physics 

4. FDA Approval Letter 

1. College or university 

transcripts 

2. Confirming letter from 

college or university 

3. Master or Bachelor degree

specifically in physics 

4. FDA Approval Letter 

Survey Training-final regs 

(20 contact hours-Master) 

(40 contact hours-Bachelor) 

1. Attestation 

2. Letter or other document from 

training program 

3. CME/CEU certificates 

4. Letter or other document 

confirming in-house or formal 

training 

5. Training gained performing 

surveys 

6. FDA Approval Letter 

1. Letter or other document from 

training program 

2. CME/CEU certificates 

3. Letter or other document 

confirming in-house or formal 

training 

4. Training gained performing 

surveys 

5. FDA Approval Letter 

1. Letter or other document 

from training program 

2. CME/CEU certificates 

3. Letter or other document 

confirming in-house or 

formal training 

4. Training gained performing 

surveys 

5. FDA Approval Letter 

Initial Experience-final regs

(1 facility-10 units-Master) 

(1 facility-20 units-Bachelor) 

1. Attestation 

2. Copy or coversheet of survey 

3. Letter from facility or listing 

from company providing the 

physics survey services 

documenting performance of 

survey done 

4. FDA Approval Letter 

1. Copy or coversheet of survey 

2. Letter from facility or listing 

from company providing the 

physics survey services 

documenting performance of 

survey done 

3. FDA Approval Letter 

1. Copy or coversheet of survey 

done under direct supervision 

2. Letter from facility or listing 

from company providing the 

physics survey services 

documenting performance of 

survey done under direct 

supervision 

3. FDA Approval Letter 
27 

Initial Mammography 

Modality Specific training8 hours-final regs 

1. Attestation for training or 

experience with investigational 

units 

2. Mammography Modality 

Specific CME/CEU certificates 

3. CME/CEU certificates plus 

agenda, course outline or 

syllabus 

4. Confirming letters from 

CME/CEU granting 

organizations 

5. Letters, certificates or other 

documents from manufacturers’ 

or other formal training courses 

6. Letter from facility where 

experience was obtained 

documenting experience in the 

new mammographic modality 

1. Attestation for experience 

with investigational units 

2. Mammography Modality 

Specific CME/CEU 

certificates 

3. CME/CEU certificates plus 

agenda, course outline or 

syllabus 

4. Confirming letters from 

CME/CEU granting 

organizations 

5. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 

 6. Letter from facility where 

experience was obtained 

documenting experience in 

the new mammographic 

modality 

1. Mammography Modality 

Specific CME/CEU 

certificates 

2. CME/CEU certificates plus 

agenda, course outline or 

syllabus 

3. Confirming letters from 

CME/CEU granting 

organizations 

4. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 

Continuing Experience 

(2 facilities-6 units/24 

months-final regs)

N/A N/A 1. Copy or coversheet of survey 

2. Letter from facility or listing 

from company providing the 

physics survey services 

documenting performance of 

survey done 

Continuing Education (15 

CME/36 months) 

N/A 1. CME/CEU certificates 

2. Confirming letters from 

CME/CEU granting 

organizations 

3. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 

1. CME/CEU certificates 

2. Confirming letters from 

CME/CEU granting 

organizations 

3. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 

Continuing Mammographic 

Modality Specific 

Education-final regs 

N/A 1. Mammography Modality 

Specific CME/CEU 

certificates 

2. CME/CEU certificates (plus 

agenda, course outline or 

syllabus 

3. Confirming letters from 

CME/CEU granting 

organizations 

4. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 

1. Mammography Modality 

Specific CME/CEU 

certificates 

2. CME/CEU certificates (plus 

agenda, course outline or 

syllabus 

3. Confirming letters from 

CME/CEU granting 

organizations 

4. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 

Requalification-Experience–

final regs–done under 

direct supervision 

N/A N/A 1. Copy or coversheet of survey 

done under direct 

supervision 

2. Letter from facility or listing 

from company providing the 

physics survey services 

documenting performance of 

survey done under direct 

supervision 

Requalification- Education N/A 1. CME/CEU certificates 

2. Confirming letters from 

CME/CEU granting 

organizations 

3. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses 

1. CME/CEU certificates 

2. Confirming letters from 

CME/CEU granting 

organizations 

3. Letters, certificates or other 

documents from 

manufacturers’ or other 

formal training courses