This article originally appeared in the March 1994 FDA Consumer . No news is good news, the maxim goes, and when a woman is told that her mammogram shows no evidence of cancer, that's good news indeed. Undetected, and thus untreated, the cancer advances. Last December, the Food and Drug Administration published in the Federal Register interim final regulations intended to ensure that all mammography done in the United States is safe and reliable. In June 1993, the assistant secretary for health delegated to FDA responsibility for implementing and enforcing the new law.
Breast cancer is the second leading cause of cancer deaths in American women.
It can find 85 to 90 percent of breast cancers in women over 50 and can discover a tumor up to two years before a lump can be felt. This striking statistic underscores the need for accurate mammography. The x-ray images must be of high quality, they must be read by physicians proficient in interpreting them, and the results must be reported promptly. All will be subject to federal inspection and certification. After initial certification, facilities must pass annual inspections by approved federal or state inspectors.