Houn F, Elliott M L, McCrohan J L
Division of Mammography Quality and Radiation Programs, Food and Drug Administration, Rockville, Maryland, USA.
Radiol Clin North Am. 1995 Nov;33(6):1059-65.
The Mammography Quality Standards Act (MQSA) of 1992 established a precedent in the practice of mammography by creating federal quality standards for all parts of the mammography system. Heralded by some as crucial so all US women can reap the full benefits of early detection of breast cancer, MQSA implementation was delegated to the Food and Drug Administration (FDA) on June 2, 1993. In this article the major historical forces that surrounded MQSA's enactment as well as the FDA's philosophy on regulation development, inspections, and compliance under MQSA is summarized.
1992年的《乳腺X线摄影质量标准法案》（MQSA）通过为乳腺X线摄影系统的各个部分制定联邦质量标准，在乳腺X线摄影实践中开创了先例。一些人认为该法案至关重要，这样所有美国女性都能充分受益于乳腺癌的早期检测。1993年6月2日，MQSA的实施被委托给食品药品监督管理局（FDA）。本文总结了围绕MQSA颁布的主要历史因素，以及FDA在MQSA下关于监管制定、检查和合规的理念。
