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of the Commonwealth of Pennsylvania

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    The Mammography Quality Standards Act of 1992 (MQSA), was signed into law on Oct. 27, 1992. The intent of the MQSA is to ensure the public receives high-quality mammography for early breast cancer detection by requiring the establishment of a federal certification and inspection program for mammography facilities. The Act authorizes the U.S. Food and Drug Administration (FDA) to obtain state and local assistance in enforcing the MQSA requirements, including annual inspections of all certified mammography facilities. On Oct. 28, 1997, the FDA published final MQSA regulations in the Federal Register. These regulations took effect on April 28, 1999

    DEP, under contract with the federal government's FDA, conducts inspections of each of the state's more than 300 facilities that perform mammographic X-ray procedures. These inspections, performed by DEP's Bureau of Radiation Protection personnel, are conducted on a schedule prescribed by the FDA. This schedule calls for a facility to be inspected once every 12 months, with a two-month grace period either way.

    To perform mammography a facility must be FDA certified. There are over 9,000 FDA certified facilities nationwide.

    A search for MQSA certified mammography facilities can be done by zip code, city, state, or facility name.

    New Rule on Breast Density Statement

    The FDA is requiring a breast density statement to be included in all lay letters as of 9/10/24. The new Federal rule requires specific language be included in the patient lay summary letter for each mammography procedure. In an effort to streamline the patient’s letter and to avoid further confusion, the Department has concluded that the FDA language meets the intent of the BREAST DENSITY NOTIFICATION ACT – 2013.

    The FDA requires one of the following statements to be included in the patient letter:

    Not Dense 900.12(c)(2)(iii)

    Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer.  Your breast tissue is not dense. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.​

    Dense 900.12(c)(2)(iv)

    Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer.  Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.​​​