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Three women stand together with magnifying glasses being held up to their breasts.

Breast Cancer Screening: FDA Proposes Amendments to Key Regulations

For the first time in 20 years, on March 27, 2019, the U.S. Food and Drug Administration (FDA) proposed new regulations to help modernize breast cancer screening. The rules would also help the FDA oversee quality standards in breast cancer screening and inpatient communications about mammogram results.

The proposed new regulations would update current standards that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). The goal is to improve the quality of patient care by incorporating current science and best practices in breast cancer screening.1,2

Opportunity to comment

The proposed changes are listed in the Federal Register for 90 days after they are published. Members of the public are invited to comment on the proposed rules during the 90-day comment period.

Impact of breast cancer

According to the National Cancer Institute, breast cancer is the second most common cancer for women, after skin cancer. The Institute reports that more than 12% of all women will get a breast cancer diagnosis at some point in their life. In 2018, more than 260,000 women were diagnosed with the disease and nearly 41,000 women died from it.1

Adding information on breast density

One of the key changes the FDA is proposing includes adding information on breast tissue density to the mammogram results given to patients and their healthcare providers.

When a radiologist reads a mammogram, he or she assigns a level of density, based on an established scale called the Breast Imaging Reporting and Data System (BI-RADS). The scale includes four levels of density. About half of women have dense or extremely dense breasts.

Dense breasts (which have relatively more fibrous tissue and less fatty tissue) are harder to evaluate on a mammogram and dense tissue can sometimes make it difficult to detect breast cancer.3

The proposed new regulations would add information for patients explaining how breast density can affect the accuracy of a mammogram. Women with denser breasts would be advised to talk to their health care provider and potentially to seek additional screening methods, to be sure their breasts can be imaged accurately.1,2

Additional rules about communication

The FDA is also proposing to add several additional rules that govern communication of mammogram results. For example, the FDA wants to include deadlines for results to be given to patients and their health care providers. Mammography results will also need to include specific identifying information about the facility that did the tests.2

New assessment categories

To enhance clear communication, the FDA proposed adding three new assessment categories to classify mammogram results. One of the new categories is “known biopsy-proven malignancy,” which would help health care providers recognize where cancer has already been identified.1,2

Incorporating regulations of new technology

Additional regulations would require that facilities use components and accessories that have been FDA approved specifically for mammography. This is especially important for digital equipment like monitors.2

Rules about recordkeeping

Some of the proposed rules would help patients keep better track of their medical records. For example, before a facility closes, the FDA would require that the center makes plans to transfer its medical records to the affected patients and their health care providers.1,2

Rules about quality care

The FDA is also proposing rules that would make it easier to enforce safety and quality standards. For example, the FDA itself would be able to communicate directly with patients and health care providers if a mammography facility was found not to comply with the required quality of care. In such a case, it could be important for a patient to get screened at a different facility.1,2

  1. FDA advances landmark policy changes to modernize mammography services and improve their quality. U.S. Food & Drug Administration. March 27, 2019. Available at: https://www.fda.gov/news-events/press-announcements/fda-advances-landmark-policy-changes-modernize-mammography-services-and-improve-their-quality Accessed May 8, 2019.
  2. Mammography Quality Standards Act. Federal Register. March 28, 2019. Available at: https://www.federalregister.gov/documents/2019/03/28/2019-05803/mammography-quality-standards-act Accessed May 8, 2019.
  3. Cancer Stat Facts: Female Breast Cancer. National Cancer Institute. Available at: https://seer.cancer.gov/statfacts/html/breast.html Accessed May 8, 2019.
  4. Dense breast tissue: What it means to have dense breasts. Mayo Clinic. March 23, 2018. Available at: https://www.mayoclinic.org/tests-procedures/mammogram/in-depth/dense-breast-tissue/art-20123968 Accessed May 7, 2019.

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