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Guidance for Industry, Mammography Quality Standards Act Inspectors, and Food and Drug Administration Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13; Availability

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13.” This document is intended to assist mammography facilities and their personnel in meeting the requirements of the Mammography Quality Standards Act (MQSA) regulations.


Submit either electronic or written comments on this guidance at any time. General comments on Agency Start Printed Page 70012guidance documents are welcome at any time.


Submit written requests for single copies of the guidance document entitled “The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13” to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit electronic comments on the guidance to Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document.

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Charles Finder, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4646, Silver Spring, MD 20993-0002, 301-796-5710.

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I. Background

MQSA (Pub. L. 102-539) was signed into law on October 27, 1992, to establish national quality standards for mammography. It is codified at 42 U.S.C. 263b. The MQSA requires that, in order to lawfully provide mammography services after October 1, 1994, all facilities, except facilities of the Department of Veterans Affairs, must be accredited by an approved accreditation body and certified by the Secretary of Health and Human Services (the Secretary) or by an approved State certification Agency (section 354(b) of the MQSA, (42 U.S.C. 263b(b))). In June 1993, the authority to approve accreditation bodies and State certification agencies and to certify facilities was delegated by the Secretary to FDA (June 10, 1993, 58 FR 32543). On October 28, 1997, FDA first published final regulations implementing the MQSA in the Federal Register (part 900 (21 CFR part 900)). The MQSA has twice been amended since its enactment, through the Mammography Quality Standards Reauthorization Acts of 1998 and 2004 (Pub. L. 105-248 and 108-365).

This guidance updates the Policy Guidance Help System (PGHS) and addresses or contains the following:

1. Updated contact information for accreditation bodies and certification agencies;

2. General guidance regarding Additional Mammography Reviews;

3. Previously approved alternative standards;

4. Centers for Medicare and Medicaid Services reimbursement;

5. Mechanisms to inform physicians and patients of mammography results;

6. Mammographic modality and its impact on personnel requirements;

7. Clarification of the personnel 6-month exemption period;

8. Information on calibrating the air kerma measuring instrument;

9. Medical physicist involvement as it applies to cassette replacement;

10. Full Field Digital Mammography (FFDM) and use of single-use cushion pads;

11. Quality control testing of computer controlled compression devices;

12. Mammography equipment evaluations of laser printers;

13. Quality control testing of monitors and laser printers;

14. Mammography equipment evaluations of new FFDM units; and

15. Mammography equipment evaluations of off-site laser printers and monitors.

The draft of this guidance was made available in the Federal Register of October 9, 2009 (74 FR 52242). The comment period closed on January 7, 2010. During the public comment period, 4 respondents submitted a total of 14 comments. In addition, the National Mammography Quality Assurance Advisory Committee reviewed the draft guidance during its January 25, 2010, meeting and provided additional comments. FDA reviewed and considered all the comments and in response FDA has modified the draft guidance as follows by:

1. Providing the most current accreditation body and certification Agency contact information;

2. Clarifying that original or lossless compressed digital image files may be acceptable for record transfer;

3. Clarifying the conditions under which an Additional Mammography Review conducted by an outside entity would be acceptable to FDA;

4. Deleting the question and answer dealing with image labeling;

5. Modifying the section on the use of attestation to include attesting to the specific mammographic modality included in personnel's initial training;

6. Clarifying the guidance on the use of non-invasive kilovolts peak (kVp) meters; and

7. Recommending the inclusion of cushion pad(s) when performing automatic exposure control testing.

In November 1998, FDA compiled all to-date final FDA guidances related to MQSA and put them into a computerized searchable database called the PGHS. The PGHS is available on the Internet at:​Radiation-EmittingProducts/​MammographyQualityStandardsActandProgram/​Guidance/​PolicyGuidanceHelpSystem/​default.htm.

FDA periodically updates the information in the PGHS and this document serves as a further update. Individuals wishing to receive automatic notification of future updates may subscribe to our E-mail ListServ by visiting​service/​subscribe.html?​code=​USFDA_​45 and following the directions.

II. Significance of Guidance

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

III. Electronic Access

Persons interested in obtaining a copy of the guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​default.htm. Guidance documents are also available at To receive “The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13,” you may either send an e-mail request to to receive an electronic copy of the document or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number 1695 to identify the guidance you are requesting.

IV. Paperwork Reduction Act

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Start Printed Page 70013Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 900 have been approved under OMB control number 0910-0309.

V. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES), either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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Dated: November 10, 2010.

Nancy K. Stade,

Deputy Director for Policy, Center for Devices and Radiological Health.

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[FR Doc. 2010-28762 Filed 11-15-10; 8:45 am]