The Mammography Quality Standards Act. An overview of the regulations and guidance

Abstract

The MQSA has imposed a set of federal regulations on every facility and radiologist that performs or interprets mammograms. Because annual inspections and paperwork are somewhat burdensome, many hope that in the future the process of FDA inspections might be streamlined for facilities with good track records and few, if any, findings at inspection. This would serve to reduce facility inconvenience and the costs of regulatory compliance without compromising patient care and outcomes. Currently, however, although not all personnel are required to be familiar with the regulations, key individuals should be conversant with the rules, FDA guidance, and methods that the facility has devised to comply with the regulations.