Updates to mammography regulations: What your patients need to know

By Carol Nathan | Medically reviewed by Jeffrey A. Bubis, DO, FACOI, FACP
Published May 4, 2023

Key Takeaways

  • Draft recommendations were issued by the US Preventive Services Task Force advising that women should start getting screening mammograms at the age of 40.

  • The FDA has updated the official mammography regulations, as overseen by the Mammography Quality Standards Act (MQSA).

  • The updates include breast density reporting requirements, FDA oversight of mammography facilities, and helping physicians assess mammograms. 

The US Preventative Task Force, a national health panel independent of the US government, has issued draft recommendations advising women to begin getting screening mammograms at age 40, 10 years earlier than prior recommendations.[] The recommendations also advise women between the ages of 40 and 74 to have screenings every 2 years, applicable to cisgender women and everyone else assigned female at birth.

The FDA has also updated federal mammography regulations, with a special focus on breast density reporting requirements, FDA oversight of mammography facilities, and helping physicians assess mammograms, according to the press release.[]

The updates are intended to improve the communication of mammography information to patients and their physicians in order to provide more informed decision making.

Receive the full benefit of mammography

The official FDA mammography oversight program is called the Mammography Quality Standards Act (MQSA) of 1992. According to a rule by the FDA, published in the Federal Register, the goal of the MQSA is to ensure that patients receive the full benefit of mammography,[] which means:

  • The mammography images need to be high quality 

  • The testing needs to be done by qualified technicians

  • Equipment needs to be properly tested and functioning 

  • Results need to be interpreted by qualified physicians

  • Results need to be communicated clearly and properly to patients and their referring healthcare professionals

Breast cancer statistics 

The FDA updated these requirements based on the high prevalence of breast cancer in the population. Breast cancer is the most common nonskin cancer, and the second leading cause of cancer death after lung cancer.

According to the CDC, as discussed in the FDA rule, more than 254,000 women were diagnosed with breast cancer in 2018, and more than 42,000 women died of the disease. These numbers are projected to have increased since then.

Dense breast tissue 

According to the FDA press release issued March 9, approximately half of women older than 40 years of age have dense breast tissue, which can make cancer more difficult to detect via mammogram. In addition, research shows that having dense breast tissue is a risk factor for developing breast cancer.

The new regulations include specific language that explains how breast density influences the accuracy of mammography, and recommends that patients with dense breast tissue discuss the cancer risks with their physician. 

Amendment details

The MQSA was updated and modernized based on new technology developments and current scientific research, including breast density information, according to the FDA rule. The new update requires the following:

  • The summary of the mammography report be written in lay terms that patients will clearly understand

  • Identifies whether the patient has dense or nondense breast tissue 

  • Includes information on the significance of breast density be included

  • Establishes four categories for reporting breast tissue density 

The new required wording of the four categories of breast density reporting is as follows:

  1. The breasts are almost entirely fatty

  2. There are scattered areas of fibroglandular density

  3. The breasts are heterogeneously dense, which may obscure small masses

  4. The breasts are extremely dense, which lowers the sensitivity of mammography

In addition, the update strengthens the FDA audit and oversight of mammography facilities and creates tools to deal with noncompliant facilities.

For example, it allows the FDA to suspend or revoke mammography facility licenses when necessary, provides processes to follow if the facility failed to receive accreditation after three attempts, and creates new rules for managing personnel records of mammography facility employees.

The FDA oversight of mammography facilities also now includes the FDA’s ability to communicate directly with patients and physicians if a facility did not meet quality standards. The goal is to make sure that any patients who might need a repeat mammogram due to deficiencies at the facility are made aware of this need. This will empower patients to make the best decisions regarding their breast healthcare. The new amendments are required to be implemented within 18 months. 

"[This] action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer."

Hilary Marston, MD, MPH, FDA Chief Medical Officer

“Since 1992, the FDA has worked to ensure patients have access to quality mammography,” Marston said in the press release. “The impact of the Mammography Quality Standards Act on public health has been significant, including a steep decrease in the number of facilities that do not meet quality standards. This means that more women have access to consistent, quality mammography. We remain committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.”

What this means for you 

Your patients will now have more information about their breast density, and you will have more information to discuss with them. You can also be reassured that the facility that conducts your patients’ mammograms is high quality. When referring patients for mammography, it makes sense to make sure that the facility is MQSA certified, which can be confirmed by searching the FDA database.[]

Read Next: My journey with breast cancer—and my healthcare providers

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