FDA Requires Mammography Reports to Tell Every Patient About Breast Density (2023)
On 10 March 2023 the U.S. Food and Drug Administration published a final rule updating the federal mammography regulations. Its best-known change requires every mammography facility in the United States to tell each patient, in nationally standard wording, whether her breast tissue is dense or not dense. The rule, titled “Mammography Quality Standards Act,” appeared in the Federal Register at 88 FR 15126 (FR Doc. 2023-04550, Docket No. FDA-2013-N-0134). Facilities had 18 months to prepare, and the FDA began enforcing it on 10 September 2024. The test itself is described on the site’s Mammogram page.
This page reports what the FDA documents say: what the agency did and when, the reasons it gave for focusing on breast density, the exact wording patients now receive, the other changes to reports, audits and records, the new tools for dealing with facilities that fall short, what the rule does not do, its status as of 18 October 2026, and how it fits earlier and later FDA steps.
Table of Contents
- What the FDA Did
- Why Breast Density, According to the FDA
- The Four Density Categories on the Report
- The Notice Every Patient Receives
- Assessment Categories and How Fast Results Go Out
- Audits, Records and Other Facility Requirements
- New Tools for Facilities That Fall Short
- What the Rule Does Not Do
- Dates and Legal Status as of 18 October 2026
- How the Rule Fits Earlier and Later FDA Steps
- Primary Documents
- Key Research Papers
- Connections
- Featured Videos
1. What the FDA Did
The FDA issued a final rule — a binding regulation, as opposed to a proposal or guidance — amending the regulations it enforces under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act. The FDA news release of 9 March 2023 describes the MQSA as “a law passed to ensure quality mammography,” under which the FDA oversees mammography facilities, “including their accreditation, certification, annual inspections and enforcement of standards.”
The rule was published in the Federal Register, the U.S. government’s daily journal of rules and notices, on 10 March 2023, filling pages 15126–15171 of volume 88. It is filed under Docket No. FDA-2013-N-0134 (a docket is the public file that holds a rulemaking’s documents and comments) and Regulation Identifier Number 0910-AH04. It changes Part 900 of Title 21 of the Code of Federal Regulations, the part that holds the mammography rules.
The rule’s own summary says the FDA was issuing the updates “to modernize the regulations by incorporating current science and mammography best practices.” It lists the intended effects: “strengthening the communication of healthcare information; allowing for more informed decision making by patients and providers (by requiring facilities to provide them with additional health information); helping to ensure the availability of qualified mammography personnel; bolstering the medical outcomes audit to provide feedback to improve mammography interpretations; modernizing technological aspects of the standards; and adding additional tools to deal with noncompliant facilities.”
The news release summed up the headline change this way: the updates “require mammography facilities to notify patients about the density of their breasts, strengthen the FDA’s oversight and enforcement of facilities and help interpreting physicians better categorize and assess mammograms.” (An interpreting physician is the doctor who reads the mammogram images and writes the report.)
FDA’s Chief Medical Officer at the time said in the release: “Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer.”
2. Why Breast Density, According to the FDA
The FDA news release gives the agency’s reasons for making density information part of every report:
- “Approximately half of women over the age of 40 in the U.S. have dense breast tissue, a description of its appearance on a mammogram.”
- “Dense breast tissue can make cancers more difficult to detect on a mammogram.”
- “Additionally, dense breasts have been identified as a risk factor for developing breast cancer.”
In other words, density is described as a feature of how the breast looks on the X-ray image, not a disease. The release states that the amendments “provide specific language explaining how breast density can influence the accuracy of mammography,” and that they “recommend patients with dense breasts talk to their health care provider about breast density, risks for breast cancer and their individual situation.”
The release also quotes the Centers for Disease Control and Prevention: “about one in eight women will get breast cancer in her life, impacting hundreds of thousands of Americans each year.” It adds the FDA’s statement that “Mammograms continue to be the best tool for breast cancer screening and detection.” The disease itself is covered on the site’s Breast Cancer page.
3. The Four Density Categories on the Report
The rule distinguishes two documents. The mammography report goes to the patient’s healthcare provider. The patient lay summary is a plain-language letter that goes to the patient. According to the FDA’s program page on the final rule, the report must now include “an overall assessment of breast density,” classified in one of four categories:
- “The breasts are almost entirely fatty.”
- “There are scattered areas of fibroglandular density.”
- “The breasts are heterogeneously dense, which may obscure small masses.”
- “The breasts are extremely dense, which lowers the sensitivity of mammography.”
“Fibroglandular” tissue is the glandular and connective tissue of the breast, as opposed to fat. The wording of the last two categories carries its own explanation: heterogeneously dense tissue “may obscure small masses,” and extremely dense tissue “lowers the sensitivity of mammography” — that is, makes the test less able to show a cancer that is there.
The report must also give the name and location of the facility that performed the exam, at a minimum the city, State, ZIP code and telephone number.
4. The Notice Every Patient Receives
Under the rule, the patient lay summary must carry the patient’s name and the name, address and telephone number of the facility, and — depending on whether the report classifies the breasts as dense or not dense — one of two fixed statements. The FDA program page gives them word for word.
If the breast tissue is dense:
“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.”
If the breast tissue is not dense:
“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.”
The two statements are identical except for one sentence: only the “dense” version says that, in some people with dense tissue, “other imaging tests in addition to a mammogram may help find cancers.” The closing sentence about talking to a healthcare provider is the FDA’s mandated wording, and it appears in both versions.
Because the wording is set in the federal regulation, the same two statements apply at every facility subject to the MQSA.
5. Assessment Categories and How Fast Results Go Out
Every report ends with an overall final assessment — the reader’s bottom-line conclusion. The FDA program page lists the categories under the amended rule:
- Negative
- Benign
- Probably Benign
- Suspicious
- Highly Suggestive of Malignancy
- Known Biopsy-Proven Malignancy
- Post-Procedure Mammogram for Marker Placement
The last two were added by the 2023 rule. When no final category can be assigned because the work-up is not finished, the report is to say either “Incomplete: Need additional imaging evaluation” or “Incomplete: Need prior mammograms for comparison.”
Timing. When the final assessment is “Suspicious” or “Highly Suggestive of Malignancy,” the report goes to the healthcare provider and the lay summary goes to the patient within 7 calendar days of the date the mammogram was interpreted. When the assessment is “Incomplete: Need prior mammograms for comparison,” the facility issues a follow-up report with a final overall assessment within 30 calendar days of the initial report, whether or not the comparison images are obtained.
Patients without a doctor. A facility that accepts patients who have no healthcare provider (self-referred patients) must keep a system for referring them to one when clinically indicated, including when their assessment is probably benign, suspicious, or highly suggestive of malignancy.
6. Audits, Records and Other Facility Requirements
The FDA program page describes several further requirements that took effect with the rule:
- Medical outcomes audit. The annual audit now includes the positive predictive value, the cancer detection rate and the recall rate, both for each interpreting physician and for the facility as a whole. In plain terms, these measure how often a reading that flags a problem turns out to be cancer, how many cancers are found per number of exams, and how often patients are called back for more imaging.
- Keeping records. Original mammograms and reports must be kept in the patient’s permanent medical record for the longest of: not less than 5 years; not less than 10 years if the patient has no further mammograms at that facility; or any longer period required by State or local law. The originals must be kept in retrievable form in the format in which they were produced, not made by copying or digitizing hard-copy originals.
- Transferring records. Transfers of mammograms and reports, or release of copies, must take place within 15 calendar days of the request. For digital mammograms or digital breast tomosynthesis sent for final interpretation, the facility must be able to provide the original digital images electronically.
- Closing facilities. Before a facility closes or stops offering mammography, it must arrange for patients and healthcare providers to have access to their records, notify its accreditation body and certification agency in writing, and make reasonable efforts to notify all affected patients.
- Equipment. All devices used in mammography must have met the FDA’s applicable premarket authorization requirements for that type of device and intended use.
- Personnel records. Facilities must keep training and experience records for interpreting physicians, radiologic technologists and medical physicists, keep them for at least 24 months after a person leaves, and provide copies to current staff and, on request within 24 months, to former staff.
- Repeated accreditation failure. If a facility has failed to become accredited after three consecutive attempts, no accreditation body may accept a new application from it for one year from the most recent failure.
The program page notes that its list “is not an exhaustive list of everything contained in the 2023 MQSA Final Rule.”
7. New Tools for Facilities That Fall Short
The news release states that “nearly all certified mammography facilities continue to meet quality standards.” It credits the MQSA with “a steep decrease in the number of facilities that do not meet quality standards” since 1992.
For the cases where a facility does not, the rule gave the FDA a new option. According to the release, the updates “enhance the FDA’s ability to communicate directly, if needed, with patients and their health care providers in cases where a facility did not meet quality standards and is not adequately communicating with patients about its deficiencies.” The stated purpose is to help ensure that “important information that could affect decisions about patient care, such as the potential need for further evaluation or a repeat mammogram, is communicated as completely as possible.”
The FDA program page adds that during a facility’s annual MQSA inspection, inspectors review documentation showing whether the facility meets the requirements, and that “the FDA may take enforcement action for noncompliance with the MQSA regulations, whether observed during an annual inspection or determined by other means.”
8. What the Rule Does Not Do
- It does not require or pay for extra imaging. The rule sets what patients are told. It does not require an ultrasound, MRI or any other additional test for people with dense breasts; the mandated notice says only that other imaging tests “may help find cancers” in some people with dense tissue.
- It does not change screening recommendations. At what age and how often to have a mammogram is set by other bodies, not by this regulation.
- It does not diagnose anything. Density is reported as a description of how the breast tissue appears on the image, alongside the separate final assessment of findings.
- It did not take effect at once. Although published in March 2023, the amendments applied from 10 September 2024, after an 18-month implementation period.
Questions about what a density result means for an individual are, as the notice itself states, for the patient’s healthcare provider.
9. Dates and Legal Status as of 18 October 2026
- Proposed: 28 March 2019 (84 FR 11669, FR Doc. 2019-05803); the comment period closed 26 June 2019.
- Announced: 9 March 2023 (FDA news release).
- Final rule published: 10 March 2023 (88 FR 15126, FR Doc. 2023-04550).
- Small entity compliance guide: availability announced 26 August 2024 (89 FR 68364, FR Doc. 2024-19059).
- Alternative standards updated: 26 August 2024 the FDA announced it was withdrawing two MQSA “alternative standards” and amending a third “due to the updated MQSA regulations,” as of 10 September 2024 (89 FR 68446, FR Doc. 2024-19058).
- Effective and enforced: 10 September 2024. The FDA program page states: “Enforcement of the MQSA regulations as amended by the 2023 MQSA Final Rule began on September 10, 2024. Facilities subject to the MQSA, must now comply with all applicable requirements, including the breast density notification.”
Status as of 18 October 2026: final and in effect since 10 September 2024. A check of the Federal Register through 18 October 2026 for FDA documents on mammography and on Docket FDA-2013-N-0134 found no document amending, staying or withdrawing the breast density requirement. The later documents found were the 2024 compliance guide, the 2024 alternative-standards notice, routine information-collection notices, and a separate 2026 device-classification proposal described in the next section.
10. How the Rule Fits Earlier and Later FDA Steps
A rule four years in the making. The FDA first proposed these updates on 28 March 2019. The proposed rule’s summary used nearly the same words as the final one: it proposed to “modernize the regulations by incorporating current science and mammography best practices” and to require facilities to provide patients and providers “with additional health information.” Both documents sit in the same docket, FDA-2013-N-0134, and carry the same Regulation Identifier Number.
Bringing the 1992 law up to date. The news release describes the amendments as helping to “bring the MQSA into the 21st century,” including “helping empower patients with more information when they are considering important decisions regarding their breast health care.”
Implementation in 2024. In August 2024 the FDA published a small entity compliance guide, which its Federal Register notice says is intended to help small entities comply with the final rule, and which describes the rule as requiring “certain breast density information be provided by mammography facilities to patients and their healthcare providers.” Enforcement followed on 10 September 2024.
A separate 2026 imaging-device proposal. On 10 August 2026 the FDA proposed to reclassify digital breast tomosynthesis (DBT) systems, a type of breast-imaging device, from class III (premarket approval) into class II (special controls), subject to premarket notification (91 FR 51406, Docket No. FDA-2026-N-7630; comments were due 9 October 2026). That proposal concerns how the devices are cleared for sale; it does not change the density notification.
Other FDA oversight of tests. The FDA’s attempt to regulate laboratory-developed tests, proposed in October 2023, is told on FDA Rule Bringing Laboratory-Developed Tests Under Device Law (2024). Other 2023 actions affecting women’s health include the approval of an over-the-counter daily birth control pill and the withdrawal of a preterm-birth drug.
11. Primary Documents
- Food and Drug Administration, HHS (2023). Mammography Quality Standards Act; Final Rule. Federal Register 88:15126–15171, 10 March 2023. Docket No. FDA-2013-N-0134; RIN 0910-AH04; 21 CFR part 900 — FR Doc. 2023-04550 (official PDF, govinfo.gov)
- U.S. Food and Drug Administration (2023). FDA Updates Mammography Regulations to Require Reporting of Breast Density Information and Enhance Facility Oversight. FDA News Release, 9 March 2023 — fda.gov news release
- U.S. Food and Drug Administration. Important Information: Final Rule to Amend the Mammography Quality Standards Act (MQSA). MQSA program page, content current as of 10 September 2024 — fda.gov MQSA final rule page
- Food and Drug Administration, HHS (2019). Mammography Quality Standards Act; Proposed Rule. Federal Register 84:11669, 28 March 2019. Docket No. FDA-2013-N-0134; RIN 0910-AH04 — FR Doc. 2019-05803
- Food and Drug Administration, HHS (2024). Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide; Guidance for Industry and Food and Drug Administration Staff; Availability. Federal Register 89:68364, 26 August 2024. Docket No. FDA-2013-N-0134 — FR Doc. 2024-19059
- Food and Drug Administration, HHS (2024). Withdrawal of Approval and Amending of Mammography Quality Standards Act Alternative Standards. Federal Register 89:68446, 26 August 2024. Docket No. FDA-2013-N-0134 — FR Doc. 2024-19058
- Food and Drug Administration, HHS (2026). Radiology Devices; Reclassification of Digital Breast Tomosynthesis System; Proposed Order. Federal Register 91:51406, 10 August 2026. Docket No. FDA-2026-N-7630 — FR Doc. 2026-16209
- Public docket FDA-2013-N-0134 — regulations.gov FDA-2013-N-0134
Key Research Papers
- Boyd NF, Guo H, Martin LJ, Sun L, Stone J, Fishell E, Jong RA, Hislop G, Chiarelli A, Minkin S, Yaffe MJ (2007). Mammographic density and the risk and detection of breast cancer. New England Journal of Medicine 356(3):227-236 — PubMed PMID: 17229950
- McCormack VA, dos Santos Silva I (2006). Breast density and parenchymal patterns as markers of breast cancer risk: a meta-analysis. Cancer Epidemiology, Biomarkers & Prevention 15(6):1159-1169 — PubMed PMID: 16775176
- Sprague BL, Gangnon RE, Burt V, Trentham-Dietz A, Hampton JM, Wellman RD, Kerlikowske K, Miglioretti DL (2014). Prevalence of mammographically dense breasts in the United States. Journal of the National Cancer Institute 106(10):dju255 — PubMed PMID: 25217577
- Kerlikowske K, Zhu W, Tosteson AN, Sprague BL, Tice JA, Lehman CD, Miglioretti DL, Breast Cancer Surveillance Consortium (2015). Identifying women with dense breasts at high risk for interval cancer: a cohort study. Annals of Internal Medicine 162(10):673-681 — PubMed PMID: 25984843
- Bakker MF, de Lange SV, Pijnappel RM, Mann RM, Peeters PHM, Monninkhof EM, Emaus MJ, Loo CE, Bisschops RHC, Lobbes MBI, de Jong MDF, Duvivier KM, Veltman J, Karssemeijer N, de Koning HJ, van Diest PJ, Mali WPTM, van den Bosch MAAJ, Veldhuis WB, van Gils CH, DENSE Trial Study Group (2019). Supplemental MRI screening for women with extremely dense breast tissue. New England Journal of Medicine 381(22):2091-2102 — PubMed PMID: 31774954
- Huang S, Houssami N, Brennan M, Nickel B (2021). The impact of mandatory mammographic breast density notification on supplemental screening practice in the United States: a systematic review. Breast Cancer Research and Treatment 187(1):11-30 — PubMed PMID: 33774734
The first two papers study how mammographic density relates to breast cancer risk and to detection on a mammogram; the third estimates how common dense breasts are among U.S. women; the fourth looks at which women with dense breasts have cancers found between screens (interval cancers); the fifth is a randomized trial of extra MRI screening for women with extremely dense breasts; the sixth reviews studies of what happened to supplemental screening after U.S. density-notification laws. These papers are listed for background; the FDA documents above are the source for every statement about the rule.