[Federal Register: February 19, 2003 (Volume 68, Number 33)]
[Notices]               
[Page 8030-8031]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19fe03-84]                         


-----------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES


Food and Drug Administration


[Docket No. 03D-0025]


 
Medical Devices: Draft Guidance for Industry and FDA; The 
Mammography Quality Standards Act Final Regulations Modifications and 
Additions to Policy Guidance Help System [numsign]6; Availability


AGENCY:  Food and Drug Administration, HHS.


ACTION:  Notice.


-----------------------------------------------------------------------


SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``The Mammography Quality 
Standards Act Final Regulations Modifications and Additions to Policy 
Guidance Help System [numsign]6; Draft Guidance for Industry and FDA.'' 
The draft guidance document is intended to assist facilities and their 
personnel in meeting the MQSA final regulations. This document deals 
with requirements related to testing of the automatic exposure control 
(AEC) component of mammography units.


DATES:  Submit written or electronic comments on the draft guidance by 
May 20, 2003. General comments on agency guidance documents are welcome 
at any time.


ADDRESSES:  Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled ``The Mammography 
Quality Standards Act Final Regulations Modifications and Additions to 
Policy Guidance Help System [numsign]6; Draft Guidance for Industry and 
FDA'' to the Division of Small Manufacturers, International, and 
Consumer 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


[[Page 8031]]


assist that office in processing your request, or fax your request to 
301-443-8818. Submit written comments on the draft guidance to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.


FOR FURTHER INFORMATION CONTACT: Charles 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


    The draft guidance serves to clarify and update previously issued 
guidance on testing the AEC component of mammography units. Due to the 
use of increasingly sophisticated mammography units, previously issued 
guidance on this matter does not adequately address the issue. This 
draft guidance was developed with input from the National Mammography 
Quality Assurance Advisory Committee during a meeting held on August 
26, 2002. Once finalized, this guidance will supersede the AEC guidance 
that currently appears in the July 18, 2002, version of the MQSA Policy 
Guidance Help System (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/mammography/robohelp/START.HTM
).
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance 
represents the agency's current thinking on testing of the AEC 
component of mammography units. 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.


II. Comments


    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the draft guidance. Submit 
a single copy of electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Two hard copies of any mailed comments are to be submitted, 
except that individuals may submit one hard copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments are available for public examination 
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.


III. Electronic Access


    To receive ``The Mammography Quality Standards Act Final 
Regulations Modifications and Additions to Policy Guidance Help System 
[numsign]6; Draft Guidance for Industry and FDA'' by fax machine, call 
the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a 
touch-tone telephone. Press 1 to enter the system. At the second voice 
prompt, press 1 to order a document. Enter the document number (1435) 
followed by the pound sign ([numsign]). Follow the remaining voice 
prompts to complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so by using the Internet. CDRH maintains an entry on the 
Internet for easy access to information including text, graphics, and 
files that may be downloaded to a personal computer with Internet 
access. Updated on a regular basis, the CDRH home page includes device 
safety alerts, Federal Register reprints, information on premarket 
submissions (including lists of approved applications and 
manufacturers' addresses), small manufacturer's assistance, information 
on video conferencing and electronic submissions, Mammography Matters, 
and other device-oriented information. The CDRH Web site may be 
accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh. A search capability for all CDRH 
guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html.
 Guidance documents are also available on the Dockets 
Management Branch Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.


    Dated: February 3, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-3874 Filed 2-18-03; 8:45 am]

BILLING CODE 4160-01-S