03-21114. Guidance for Industry and FDA Staff on the Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #6; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 #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 #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In the Federal Register of February 19, 2003 (68 FR 8030), FDA published a document entitled “Medical Devices: Draft Guidance for Industry and FDA; The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #6; Availability” for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 #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 (#). 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.