Zdrowie i gospodarka · 03/04/1996

Quality Mammography Standards; General Preamble and Proposed Alternative Approaches

The Food and Drug Administration (FDA) is proposing to amend its interim regulations issued under the Mammography Quality Standards Act of 1992 (the MQSA). In addition, FDA is also setting forth ideas for the application of alternative performance and outcome-based standards to ensure quality mammography. FDA is soliciting comments on these alternatives as possible ways of meeting the objectives of Executive Order 12866, which requires Federal agencies to, where feasible, specify performance objectives, rather than specifying the behavior and manner of compliance and to avoid duplicative regulations. Elsewhere in this issue of the Federal Register, FDA is proposing amendments to the requirements for accreditation bodies, procedures for facility certification and quality standards for mammography personnel, equipment and practices, including quality assurance. These actions are being taken to ensure adequate and consistent evaluation of mammography facilities on a nationwide basis.