[Federal Register Volume 63, Number 216 (Monday, November 9, 1998)]
[Notices]
[Page 60352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29751]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0633]
Approval of an Alternative Requirement of the Mammography Quality
Standards Act; 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 a document entitled ``Approval of an Alternative
Requirement of the Mammography Quality Standards Act'' (the MQSA). The
MQSA final regulations require that the collimation of the mammography
unit permit the x-ray field to extend to or beyond the edges of the
image receptor. FDA has approved a request from General Electric (GE)
Medical Systems for an alternative to the MQSA requirement to apply to
GE Senographe mammographic systems.
ADDRESSES: Submit written requests for single copies of the ``Approval
of an Alternative Requirement of the Mammography Quality Standards
Act'' document to the Division of Mammography Quality and Radiation
Programs, Center for Devices and Radiological Health (HFZ-240), 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 301-594-3306. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the alternative requirement.
FOR FURTHER INFORMATION CONTACT: Roger L. Burkhart, 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
The MQSA final regulations in 21 CFR part 900 will become effective
on April 28, 1999. Under Sec. 900.12(e)(5)(vii)(A) (21 CFR
900.12(e)(5)(vii)(A)), the regulations will require that the
collimation of a mammography unit permit the x-ray field to extend to
or beyond the edges of the image receptor. This provision was made
because some facilities stressed the importance of blackening the x-ray
film to the edges. These facilities stated that this would help
eliminate the effect of view box light passing through the unexposed
edges of the film on accuracy of interpretation. However, the current
Electronic Product Radiation Control (EPRC) performance standards
require that mammography units be manufactured to ensure that the x-ray
field does not extend beyond the nonchest wall edges of the image
receptor.
Although it is possible for a mammography unit to meet both of
these sets of standards, it has come to the agency's attention that
certain GE models were designed to prevent the x-ray field from
reaching the nonchest wall edges of the image receptor. These models,
which make up a large proportion of the mammography units currently in
use in facilities, were designed to meet the EPRC standard. GE
requested that an alternative requirement be approved that would allow,
but not require, the x-ray field to extend to or beyond the edge of the
image receptor, permitting continued use of the presently installed
units without modification.
Under the provisions of 21 CFR 900.18, the agency granted the
request for an alternative requirement. The alternative requirement
applies to all GE Senographe mammographic systems including models
500T, 600T, 700T, 800T, and DMR.
II. Electronic Access
In order to receive a copy of the ``Approval of an Alternative
Requirement of the Mammography Quality Standards Act'' to
Sec. 900.12(e)(5)(vii)(A) via your fax machine, call the CDRH Facts-On-
Demand system at 800-899-0381 or 301-827-0111 from the touch-tone
telephone. At the first voice prompt press 1 to access the Division of
Small Manufacturers Assistance Facts, at second voice prompt press 2,
and then enter the document number 2249 followed by the pound sign (#).
Then follow the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the alternative
requirement may also do so using the World Wide Web (WWW). The Center
for Devices and Radiological Health (CDRH) maintains an entry on the
WWW for easy access to information including text graphic, 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 the ``Approval
of an Alternative Requirement of the Mammography Quality Standards
Act'' to Sec. 900.12(e)(5)(vii)(A), 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''. ``Approval of an Alternative Requirement of the
Mammography Quality Standards Act'' to Sec. 900.12(e)(5)(vii)(A) will
be available at ``http://www.fda.gov/cdrh/dmqrp.html''.
Dated: October 28, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health
[FR Doc. 98-29751 Filed 11-6-98; 8:45 am]
BILLING CODE 4160-01-F
