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Updates to mammography rules

USFDA | Updated on March 29, 2019 Published on March 29, 2019

Mammograms continue to be the best primary tool for breast cancer screening. The United States Food and Drug Administration (USFDA) certifies facilities to perform mammography and it clears and approves new mammography devices for sale in the US.

Congress enacted the Mammography Quality Standards Act (MQSA) in 1992 to ensure all women have access to quality mammography for the detection of breast cancer in its early, most treatable stages. Always look for the MQSA certificate at the mammography facility, which is required to be displayed, and indicates that the facility met the national baseline standards for mammography. To continue to protect women's health, the FDA is proposing updates to the mammography regulations to reflect advances in mammography technology and processes since the current regulations were published.

A mammogram is a series of low-dose X-ray pictures of the breasts. Getting a regular mammogram is the best way to find breast cancer early, because it can show growths in the breast or other signs of breast cancer when they are too small for you or your healthcare provider to feel them. Regular screenings are important, and the risk of breast cancers varies from person to person, so it's a good idea to ask your healthcare provider when and how often you should schedule a mammogram.

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If you’re worried about how the procedure feels, you should know that most women do not find it painful. Some women may find the pressure on the breast uncomfortable, but it lasts for only a few seconds.

FDA regulations already require that facilities provide patients a summary, in easy-to-understand language, of their mammography results within 30 days after the mammogram, and that they make reasonable attempts to communicate the results as soon as possible if indications of potential cancer are found. The proposed changes attempt to give more information to the individual and healthcare provider to make an informed decision.

Source: USFDA

Published on March 29, 2019

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