Draft Proposed Regulations on Mammography X-ray Equipment Standards and on Medical Physicists Standards; Availability

요약

The Food and Drug Administration (FDA) is announcing the availability of two draft proposed regulations prepared by the Center for Devices and Radiological Health (CDRH). One draft contains standards for mammography x-ray equipment and the other draft contains medical physicists standards. The draft documents are intended to implement the Mammography Quality Standards Act of 1992 (the MQSA). The MQSA requires the establishment of a Federal certification and inspection program for mammography facilities, regulations and standards for accrediting bodies for mammography facilities, and standards for mammography equipment, personnel, and practices, including quality assurance. Prior to publishing the proposed regulations, FDA is making available two draft regulations concerning personnel qualifications for medical physicists and the quality standards for mammography equipment in order to receive additional information about these subjects.