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for mammography facility personnel, inspectors, and consumers about the implementation of the Mammography Quality Standards Act of 1992 (MQSA) |
PERFORMANCE EVALUATION OF ACCREDITATION BODIES UNDER THE MAMMOGRAPHY QUALITY STANDARDS ACT OF 1992 as amended by the MAMMOGRAPHY QUALITY STANDARDS REAUTHORIZATION ACT OF 1998 |
January 1, 2005 through December 31, 2005
Executive Summary
The goal of the Mammography Quality Standards Act (MQSA) of 1992, as amended by the Mammography Quality Standards Reauthorization Acts of 1998 and 2004, is to assure that facilities meet standards for performing high quality mammography. The Food and Drug Administration (FDA) administers MQSA. Among other things, MQSA provides for FDA-approved accreditation bodies (ABs) to evaluate and accredit mammography facilities based upon quality standards. Based on successful completion of this process, the FDA (or state certifying agency) then issues certificates to facilities so that they can legally operate. MQSA requires annual reports to Congress on AB performance. This tenth annual report covers the period from January 1, 2005, through December 31, 2005.
To implement the MQSA (Section 354q of the Public Health Service Act, (42 U.S.C. 263b)), the FDA issued final regulations that became effective on April 28, 1999 (21 CFR Part 900). The final regulations (21 CFR 900.5) state that the FDA’s evaluation of ABs shall include a(n):
(a) | Assessment of the reports of FDA or State inspections of facilities accredited by the body as well as any additional information deemed relevant by FDA that has been provided by the accreditation body or other sources or has been required by FDA as part of its oversight initiatives; |
(b) | Determination of whether there are major deficiencies in the AB’s performance that, if not corrected, would warrant withdrawal of the approval of the AB under the provisions of Section 900.6. |
Status of Accreditation Bodies
The FDA approved the American College of Radiology, a private, nonprofit organization, as well as the States of Arkansas, Iowa, and Texas as ABs under the MQSA and the final regulations. Since the term of approval is for a period of seven years, each AB’s approval was set to expire on April 28, 2006. Thus, each AB (per regulation) began the renewal process in the fall of 2005. By the end of 2005, the FDA approved each AB’s renewal application. Although the expiration for renewal is April 28, 2013, the FDA will continue to annually review each AB’s performance to determine its compliance with the final regulations.
Evaluation of Accreditation Bodies
To assess overall performance, the FDA evaluates the AB’s in the following areas:
The FDA evaluates AB performance in the areas listed above through:
Findings from CY 2005 AB Performance Evaluations
The following items are the highlights of the FDA’s calendar year 2005 Report to Congress:
The FDA and the ABs, working in partnership with the certified mammography facilities in the United States, as well as the states participating in inspections and other MQSA activities, are ensuring quality mammography across the Nation.
Updated December 1, 2006
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