[Federal Register: August 19, 2003 (Volume 68, Number 160)]
[Notices]               
[Page 49781-49782]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19au03-64]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0025]

 
Guidance for Industry and FDA Staff on 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.

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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 [numsign]6.'' This document deals with testing of 
a mammography unit's Automatic Exposure Control (AEC) component and is 
intended to provide guidance to mammography facilities and their 
personnel. It represents FDA's current thinking on this aspect of the 
final regulations implementing the Mammography Quality Standards Act.

DATES: Submit written or electronic comments on this guidance at any 
time. 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 guidance document entitled ``The Mammography Quality 
Standards Act Final Regulations Modifications and Additions to Policy 
Guidance Help System [numsign]6'' to the Division of Small 
Manufacturers, International, and Consumer Assistance (HFZ-220), Center 
for Devices and Radiological Health (CDRH), 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 concerning this guidance to the Divison of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. 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 (HFZ-240), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-827-0009.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 19, 2003 (68 FR 8030), FDA 
published a document entitled ``Medical Devices: Draft Guidance for 
Industry and FDA;

[[Page 49782]]

The Mammography Quality Standards Act Final Regulations Modifications 
and Additions to Policy Guidance Help System [numsign]6; Availability'' 
for public comment. Before the public comment period closed on May 20, 
2003, 2 respondents submitted a total of 14 comments. In addition, the 
National Mammography Quality Assurance Advisory Committee reviewed the 
draft guidance during its April 28, 2003, meeting and provided 
additional comments. In response to those comments, FDA has modified 
the guidance as follows by:
    1. Further clarifying the term ``equipment configuration,''
    2. Adding different image receptor sizes as separate equipment 
configurations,
    3. Not recommending that target-filter combinations be tested as 
separate equipment configurations, and
    4. Emphasizing the need to minimize non-AEC component variability 
when conducting the AEC performance test.

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 on testing of a mammography unit's AEC 
component. 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

    To receive ``The Mammography Quality Standards Act Final 
Regulations Modifications and Additions to Policy Guidance Help System 
[numsign]6'' by FAX, 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 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://www.fda.gov/cdrh. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/cdrh/guidance.html. 
Guidance documents are also available on the Division of Dockets 
Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Comments

    Interested persons may submit written or electronic comments to the 
Division of Dockets Management (see ADDRESSES) at any time. Submit a 
single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one copy. Comments are to 
be identified
with the docket number found in brackets in the heading of this 
document. Comments received may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 4, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-21114 Filed 8-18-03; 8:45 am]

BILLING CODE 4160-01-S