Document ID: FDA-2009-D-0448-0007
Agency: fda
Document Type: Notice
Title: Guidance for Industry, Mammography Quality Standards Act Inspectors, and Staff; Availability: Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13
Posted Date: 2010-11-16T05:00Z

[Federal Register Volume 75, Number 220 (Tuesday, November 16, 2010)]
[Notices]
[Pages 70011-70013]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28762]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0448]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency

[[Page 70012]]

guidance documents are welcome at any time.

ADDRESSES: 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 http://www.regulations.gov. 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.

FOR FURTHER INFORMATION CONTACT: 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.

SUPPLEMENTARY INFORMATION:

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: http://www.fda.gov/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 http://service.govdelivery.com/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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. 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 
dsmica@fda.hhs.gov 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

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Reduction 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.

    Dated: November 10, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-28762 Filed 11-15-10; 8:45 am]
BILLING CODE 4160-01-P