FDA's mammography facility quality assurance program.

Abstract

To summarize, the key features of the MQSA program are: To operate lawfully after October 1, 1994, a mammography facility must be certified by FDA as providing quality mammography services. For a facility to be certified, it must be accredited by a federally-approved private nonprofit or state accreditation body. To be accredited, the facility must undergo periodic review of its clinical images and meet federally-developed quality standards for personnel qualifications, quality assurance programs, and recordkeeping and reporting. To maintain its certification, the facility must pass an annual inspection conducted by federal or state personnel. If congress grants FDA authority, the agency will establish interim standards initially but will eventually replace them with more comprehensive final standards. After October 1, 1994, mammography facilities unable to comply with the quality standards in effect at a given time will not be permitted to continue in operation. FDA believes that once the comprehensive standards and inspection program are in place, the goal of assuring all women access to quality mammography will soon be reached.