Contains Nonbinding Recommendations 
Guidance for Industry, MQSA 
Inspectors, and FDA  
 
The Mammography Quality 
Standards Act Final Regulations: 
Modifications and Additions to 
Policy Guidance Help System #12  
 
Document issued on: February 2, 2007 
 
This document modifies and updates guidance appearing in the Policy 
Guidance Help System 
 
 
 
For questions regarding this document contact Charles Finder at 301-796-5710 or by email at 
charles.finder@fda.hhs.gov.  
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug 
Administration 
Center for Devices and Radiological Health 
Division of Mammography Quality and Radiation Programs 
Office of Communication, Education, and Radiation Programs 
  1 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.   
 
Note: Questions and answers that are currently in the PGHS and are not being modified are not 
included in this document. 
 
Additional Copies 
 
Additional copies are available from the Internet at: http://www.fda.gov/cdrh/mammography.  
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 (1623) to identify the guidance you are requesting.   
 
  2 Contains Nonbinding Recommendations 
 
Guidance for Industry, MQSA Inspectors, 
and FDA Staff  
 
The Mammography Quality Standards Act 
Final Regulations: Modifications and 
Additions to Policy Guidance Help System 
#12  
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking 
on this topic.  It does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public.  You can use an alternative approach if the approach 
satisfies the requirements of the applicable statutes and regulations.  If you want to discuss 
an alternative approach, contact the FDA staff responsible for implementing this 
guidance.  If you cannot identify the appropriate FDA staff, call the appropriate number 
listed on the title page of this guidance.  
 
Introduction 
This document is intended to provide guidance to mammography facilities and their 
personnel.  It represents the Food and Drug Administrations (FDA) current thinking on the 
final regulations implementing the Mammography Quality Standards Act (MQSA) (Public 
Law 102-539).  This guidance document updates previous guidance and deals with the issues 
of: 
1.  reducing the annual facility reporting requirements to accreditation bodies 
2.  quality control testing of infrequently used laser printers used for full field digital 
mammography 
3.  clarifying the information that needs to be supplied to the certificate extension 
program for computed radiography digital mammography systems. 
 
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. 
 
  3 Contains Nonbinding Recommendations 
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, in order to lawfully provide mammography 
services after October 1, 1994, all facilities, except facilities of the Department of Veterans 
Affairs, must be accredited by an approved accreditation body and certified by the Secretary 
of Health and Human Services (the Secretary) or by an approved State certification body 
(section 354(b) of the MQSA; 42 USC 263b(b)).  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 final regulations implementing the 
MQSA in the Federal Register (21 CFR Part 900).   
 
In November 1998, FDA compiled all final FDA guidances related to MQSA and put them 
into a computerized searchable database called the Policy Guidance Help System (PGHS).  
The PGHS is available on the Internet at: 
www.fda.gov/cdrh/mammography/robohelp/start.htm
 
FDA periodically updates the information in the PGHS and this document serves as a further 
update.  Individuals wishing to receive automatic notification of future updates may 
subscribe to our E-mail ListServ by visiting 
http://service.govdelivery.com/service/subscribe.html?code=USFDACDRH_17 and 
following the directions there. 
 
The following question and answer is being added to Accreditation and 
Certification/Accreditation Body Regulations 
 
Background: 
The MQSA interim regulations, published on December 21, 1993, required facilities to 
submit to their accreditation body on an annual basis the results of their annual physics 
  4 Contains Nonbinding Recommendations 
survey.  The MQSA final regulations, published on October 28, 1997, has a similar 
requirement (see below).  The purpose of this regulation was for the accreditation body to 
evaluate these surveys as part of accreditation oversight and to serve as a check on the review 
done as part of the facilitys annual MQSA inspection.  However, accreditation bodies have 
been reviewing these surveys since 1994 and the need for an annual review has come into 
question.  This matter was discussed with the National Mammography Quality Assurance 
Advisory Committee (NMQAAC) on September 28, 2006. It was the committees consensus 
that annual reporting of the physics survey was no longer necessary.  The Institute of 
Medicine also recommended that this requirement be deleted from the regulations.  These 
groups concluded that having the accreditation body review the physics survey at the time of 
reaccreditation (once every three years) provides adequate oversight.  Until such time as 
FDA can proceed with the notice and comment process for deleting this regulation, FDA 
intends to exercise enforcement discretion as to this requirement as of July 1, 2007.  The 
purpose of this document is to inform the mammography community and make the necessary 
changes to the Policy Guidance Help System. 
 
Citation: 
900.4(e)(2) The accreditation body shall require that all facilities undergo an annual survey 
to ensure continued compliance with the standards referenced in paragraph (b) of this 
section and to provide continued oversight of facilities quality control programs as they 
relate to such standards. The accreditation body shall require for all facilities that: 
    (i) Such surveys be conducted annually; 
    (ii) Facilities take reasonable steps to ensure that they receive reports of such surveys 
within 30 days of survey completion; and 
    (iii) Facilities submit the results of such surveys and any other information that the body 
may require to the body at least annually. 
 
Question 1: Must a facility submit the results of its annual medical physicist survey to 
its accreditation body on an annual basis? 
No.  Due to recommendations from the National Mammography Quality Assurance Advisory 
Committee and the Institute of Medicine, FDA intends to propose deleting the requirement 
for annual submission of physicist surveys and in the interim, intends to exercise 
enforcement discretion as to this requirement as of July 1, 2007.  Facilities are reminded that 
even after that date, they must continue to have the physicist survey performed annually and 
to submit the results of the physicist survey as part of the initial and reaccreditation process 
(21 CFR 900.4(e)(1)). Facilities must also follow their accreditation bodys procedures for 
updating the body when significant changes take place in the facility (section 354(e)(3) of the 
MQSA). 
 
The following question and answer is being added to Quality Assurance/Equipment/ 
Other Modalities Quality Control Tests 
 
Background: 
When FFDM systems were first approved by the FDA, they were approved only for hard 
copy final interpretation (laser film).  After FDA approved FFDM for soft copy (monitor) 
  5 Contains Nonbinding Recommendations 
final interpretation, facilities started using both methods for interpretation.  However, the 
majority of facilities now use only soft copy for final interpretation. 
 
MQSA regulations require that all facilities transfer the original mammograms upon patient 
request (21 CFR 900.12(c)(4)).  Whether or not the facility is using hard copy for final 
interpretation, it needs to be able to produce final interpretation quality hard copy images for 
those patients, their representatives, and health-care providers who request hard copy transfer 
of the mammogram.  In order to conform to this requirement, all facilities need access to a 
printer. In addition, if the facility is retaining the mammogram in hard copy rather than 
electronic form, the hard copy image must be of final interpretation quality. 
 
This matter was discussed with the National Mammography Quality Assurance Advisory 
Committee (NMQAAC) on September 29, 2006. It was the committees consensus that 
facilities need to be performing quality control testing on laser printers in order for the 
facility to produce hard copy images of final interpretation quality. 
 
Citation: 
900.12(e)(6):  Quality Control tests  other modalities.  For systems with image receptor 
modalities other than screen-film, the quality assurance program shall be substantially the 
same as the quality assurance program recommended by the image receptor manufacturer, 
except that the maximum allowable dose shall not exceed the maximum allowable dose for 
screen-film systems in paragraph (e)(5)(vi) of this section.  
 
Question 4: Must a facility perform all the required QC testing on a laser printer even 
if the facility is using only soft copy for final interpretation and is using the printer only 
to provide final interpretation quality hard copy images to patients, their 
representatives, and health-care providers or for retention purposes?  If not, is the 
facility subject to citation during an MQSA inspection?  
Yes to both questions. Even if a facility is using the printer only for these purposes and never 
actually provides a final interpretation report based on the hard copy images, it still must 
perform all the required printer QC tests at their appropriate frequencies or, prior to printing 
clinical images for patients and health-care providers or for retention, whichever is less.   
 
Because of a misunderstanding in the professional community regarding QC testing in these 
situations, we have not universally enforced this requirement.  However, this guidance serves 
to clarify this matter and those facilities that fail to perform the required QC testing after July 
1, 2007 will be subject to citation. 
 
The following questions and answers are being added to Accreditation and 
Certification/ Full Field Digital Mammography (FFDM) Certification Extension 
Program 
 
Background: 
FDA has used the certificate extension program to allow facilities to legally use Full Field 
Digital Mammography (FFDM) systems that have been approved for commercial use by 
FDAs Office of Device Evaluation (ODE) but do not yet have an approved accreditation 
  6 Contains Nonbinding Recommendations 
body to accredit the system.  With ODEs approval of computed radiography systems for 
mammographic use, additional guidance to facilities is needed to address the physical 
differences between these systems and earlier approved FFDM units. 
 
Question 14: FDA has approved a Computed Radiography (CR) system for 
mammography use. From an MQSA standpoint, are there any differences between a 
CR system and a full field digital mammography (FFDM) system?  
While the systems have significant physical differences, FDA treats them the same from an 
MQSA regulatory standpoint. CR systems are considered part of the mammographic 
modality known as FFDM. This means that facilities wishing to use a CR system must meet 
all applicable MQSA requirements (21 CFR Part 900), including those specific to FFDM 
units. For example, all personnel using a CR system must have completed at least 8 hours of 
training specific to digital mammography prior to using the new CR system on patients (21 
CFR 900.12(a)(1)(ii)(C), (a)(2)(iii)(E), (a)(3)(iii)(C)). However, because CR systems are part 
of the FFDM mammographic modality, personnel who have already obtained 8 hours of 
training in FFDM do not have to obtain another 8 hours in CR prior to use on patients.  
 
Question 15: Under the Certification Extension Program, does a facility wishing to add 
a CR system to a screen film (S-F) unit need to keep accreditation for an existing unit?  
Yes, the facility will need to maintain accreditation with an FDA-approved accreditation 
body (AB) for at least one unit other than the CR system. This means the facility must either 
keep accreditation for the S-F unit, with which the CR system shares the cassette holder, or 
another S-F unit or an FFDM unit. Once the FDA approves an AB to accredit CR systems, 
the facility will have to apply to that AB for accreditation of the CR system. Once it gets 
accreditation from the AB for the CR system, the facility will not need to maintain the 
additional accreditation unless it wishes to continue using the other units.  
Note: Your facility is also required to undergo an annual onsite MQSA inspection of the CR 
unit(s) during the inspection of S-F and/or FFDM accredited unit(s) (section 354 of the 
MQSA).  
 
Question 16: If we have multiple S-F units and plan to use CR with all of them, do we 
need approval to extend our accreditation and certification to add CR to all of them?  
Yes. Since FDA grants accreditation and certification extension for the use of a CR system 
only with a specific mammography unit, the additional units are not covered even if they are 
the same make and model.  
 
Question 17: What inspection costs are associated with CR certification?  
FDA will treat an S-F unit that is equipped with a CR system as two separate units (one S-F; 
one FFDM). Therefore, inspectors will inspect a single physical unit that is used to perform 
S-F mammography and CR mammography as two separate units, and FDA will bill the 
facility for two units. Once FDA approves an accreditation body to accredit CR systems, a 
facility may begin the accreditation process for the CR unit and drop the S-F accreditation, 
thereby reducing their unit inspection and accreditation costs.  
 
Question 18: How will an inspector inspect a CR unit?  
  7 Contains Nonbinding Recommendations 
Using his/her laptop computer, the inspector will download for inspection the record for a 
mammography unit(s) that uses CR in the same manner as any other FFDM unit, and then 
open the applicable inspection procedure screens. If a unit(s) is being used for both S-F and 
CR on the same physical unit(s), the inspector will need to download a separate S-F record, 
as well.  
If an inspector determines that CR is being used on an S-F unit(s) for which there is no 
certificate extension approval, the inspector will: 
  1. add a new record for the CR unit(s) into the database (e.g., with the same model, 
description, and serial number as the S-F unit(s) but with an image receptor type of 
CR);  
  2. mark it as unaccredited (resulting in a Level 1 or 2 inspection observation);  
  3. answer the mammography equipment evaluation (MEE) question and all of the 
applicable questions in the QC records and Survey Report sections accordingly; and,  
  4. instruct the facility that it should stop using the unit(s) until it applies to FDA for 
certificate extension on the unit(s) and has obtained certificate extension for the 
unit(s).  
 
If a facility is performing both S-F and CR mammography using the same physical unit(s), 
the inspector will treat the inspection as 2 separate units and the facility will be billed 
accordingly.  
 
 
  8