Quality standards and certification requirements for mammography facilities--FDA. Interim rule; opportunity for public comment.
The Food and Drug Administration (FDA) is issuing regulations to implement the Mammography Quality Standards Act of 1992 (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. This regulation, which amends two previously published interim rules, modifies and adds to the definitions previously set forth. In addition, the interim rule provides a mechanism to request permission to meet alternative requirements, other than those previously set forth, if the proposed alternative requirement is at least as effective as the existing quality standards in achieving quality mammography services for women.
D000554:Ambulatory Care Facilities / Q000592:standards*; D002568:Certification / Q000331:legislation & jurisprudence*; 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