Quality standards and certification requirements for mammography facilities--FDA. Interim rule with request for comments.
The Food and Drug Administration (FDA) is issuing regulations to implement the Mammography Quality Standards Act of 1992 (the MQSA), which 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. This rule establishes requirements for certification of mammography facilities, including quality standards for mammography. This action is being taken to assure safe, accurate, and reliable mammography on a nationwide basis. The agency requests comments on the contents of this document.
D000554:Ambulatory Care Facilities / Q000331:legislation & jurisprudence / Q000592:standards*; D001943:Breast Neoplasms / Q000175:diagnosis; D002568:Certification / Q000191:economics / Q000331:legislation & jurisprudence*; D003365:Costs and Cost Analysis / Q000706:statistics & numerical data; D003625:Data Collection; D005161:Facility Regulation and Control / Q000331:legislation & jurisprudence / Q000592:standards; D005260:Female; D006801:Humans; D008327:Mammography / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000191:economics / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration