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# FDA Proposing Mammography Amendments
- URL: https://www.fdaweb.com/fda-proposing-mammography-amendments/
- Published: 2019-03-27T12:00:00.000Z
- Updated: 2026-09-15T01:15:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143712

For the first time in over 20 years of regulating mammography facilities, FDA is proposing amendments to regulations to help improve the quality of mammography services. An agency [news release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634509.htm?utm%5Fcampaign=032719%5FPR%5FMQSA&utm%5Fmedium=email&utm%5Fsource=Eloqua) says the changes would “expand the information mammography facilities must provide to patients and healthcare professionals, allowing for more informed medical decision-making. It would also modernize mammography quality standards and better position FDA to enforce regulations that apply to the safety and quality of mammography services.”

Among the proposed amendments to improve communication and medical decision-making is the addition of breast density information to the mammography lay summary letter provided to patients and the medical report provided to their referring healthcare professionals. The amendments also want to enhance information provided to healthcare professionals by proposing to codify three additional categories for assessing mammograms, including adding an important category titled “known biopsy proven malignancy,” which would help identify for healthcare professionals those cases where cancer being mammographically evaluated for therapy are already known and identified. Also, both healthcare professionals and patients would receive in their reports and lay summary letters more detailed identifying information about the mammography facility to aid in post-exam communications.