[Federal Register Volume 64, Number 53 (Friday, March 19, 1999)]
[Notices]
[Pages 13590-13591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6666]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0697]


Compliance Guidance: The Mammography Quality Standards Act 
FinalRegulations Document #1; 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 ``Compliance Guidance: The 
Mammography Quality Standards Act Final Regulations Document #1.'' The 
final regulations implementing the Mammography Quality Standards Act of 
1992 (the MQSA) will become effective April 28, 1999, and will replace 
the interim regulations which, under the MQSA, currently regulate 
mammography facilities. The guidance is intended to assist facilities 
and their personnel to meet the MQSA final regulations.

DATES:  Written comments may be submitted at any time.

ADDRESSES:  Submit written requests for single copies on a 3.5'' 
diskette of the guidance entitled ``Compliance Guidance: The 
Mammography Quality Standards Act Final Regulations Document #1'' to 
the Division of Small Manufacturers Assistance (HFZ-220), Center for 
Devices and Radiological Health, Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive 
labels to assist that office in processing your request, or fax your 
request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit written comments on ``Compliance Guidance: The Mammography 
Quality Standards Act Final Regulations Document #1'' to the contact 
person listed below.

FOR FURTHER INFORMATION CONTACT: Charles A. Finder, Center for Devices 
and Radiological Health (HFZ-240), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-594-3332.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA published a notice of availability of a draft of this guidance 
for public comment in the Federal Register of August 27, 1998 (63 FR 
45828). The agency discussed the draft guidance

[[Page 13591]]

with a working group of the Conference of Radiation Control Program 
Directors in October 1998 and with the National Mammography Quality 
Assurance Advisory Committee in November 1998. The guidance has been 
modified from the original draft proposal to address public comments 
and to conform to the changes mandated by the Mammography Quality 
Standards Reauthorization Act (MQSRA) of 1998. The major changes 
include:
    1. New guidance for patient communication of results to conform to 
MQSRA,
    2. Reinstatement of the exemption from adverse finding after 
continuing experience requalification for interpreting physicians and 
extension to radiologic technologists,
    3. Modification of the Automatic Exposure Control mode guidance so 
that it applies to those modes used clinically at the facility,
    4. Revision of the repeat analysis guidance to be consistent with 
currently accepted practice,
    5. Inclusion of the fact that FDA has proposed changes to the 
collimation requirements,
    6. Clarification of what constitutes a major change to the film 
processor,
    7. Further clarification as to what constitutes a ``serious 
complaint'',
    8. Raising inspection finding levels for failure to have a standard 
operating procedure for infection control and handling consumer 
complaints, and
    9. Raising inspection finding levels for failure to comply with 
manufacturer's recommendations when performing digital mammography.

II. Significance of Guidance

    This guidance represents the agency's current thinking on the final 
regulations implementing the MQSA. 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 applicable statute, regulations, or both.
    The agency has adopted good guidance practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This guidance is issued as a level 1 guidance consistent with 
GGP's.

III. Electronic Access

    In order to receive ``Compliance Guidance: The Mammography Quality 
Standards Act Final Regulations Document #1'' via your fax machine, 
call the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 301-827-
0111 from a touch-tone telephone. At the first voice prompt press 1 to 
access DSMA Facts, at second voice prompt press 2, and then enter the 
document number (1499) followed by the pound sign (#). Then follow the 
remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the World Wide Web (WWW). CDRH maintains an entry on the WWW 
for easy access to information including text, graphics, and files that 
may be downloaded to a personal computer with access to the WWW. 
Updated on a regular basis, the CDRH home page includes ``Compliance 
Guidance: The Mammography Quality Standards Act Final Regulations 
Document #1'', device safety alerts, Federal Register reprints, 
information on premarket submissions (including lists of approved 
applications and manufacturers' addresses), small manufacturers' 
assistance, information on video conferencing and electronic 
submissions, mammography matters, and other device-oriented 
information. The CDRH home page may be accessed at ``http://
www.fda.gov/cdrh''. The ``Compliance Guidance: The Mammography Quality 
Standards Act Final Regulations Document #1'' will be available at 
``http://www.fda.gov/cdrh/dmqrp.html''.

IV. Comments

    Interested persons may, at any time, submit to the contact person 
(address above) written comments regarding this guidance. Such comments 
will be considered when determining whether to amend the current 
guidance.

    Dated: March 10, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-6666 Filed 3-18-99; 8:45 am]
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