Requirements for accrediting bodies of 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 (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 procedures for application to FDA for approval as an accrediting body and requirements and responsibilities of such bodies. This action is being taken to assure adequate and consistent evaluation of mammography facilities on a nationwide level and to help assure their compliance with quality standards. The agency requests comments on the contents of this document.
D000068:Accreditation / Q000191:economics / Q000331:legislation & jurisprudence*; D000554:Ambulatory Care Facilities / Q000331:legislation & jurisprudence / Q000592:standards*; D001943:Breast Neoplasms / Q000175:diagnosis; 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*; D011787:Quality of Health Care / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration