Zdrowie i gospodarka · 26/01/1995

Draft Proposed Regulations on Quality Standards and Certification Requirements for Mammography Facilities; Availability

The Food and Drug Administration (FDA) is announcing the availability of draft proposed regulations prepared by the Center for Devices and Radiological Health (CDRH) to implement the Mammography Quality Standards Act of 1992 (MQSA). The drafts contain minimum quality standards for mammography facilities in the following areas: Personnel standards, medical outcomes audits, medical records and mammography reports, quality assurance, mobile mammography, accreditation bodies, implant imaging, mammography equipment, variances, consumer complaint mechanism, and quality control.