Short, sourced explanations of the terms, rules, and measures behind breast imaging operations. Each one covers what it is, how it works, and why it matters.
The lay summary must contain one of two statements about breast density, chosen by the density category in the mammography report (21 CFR 900.12(c)(2)(iii) and (iv)).
How it works
If the report says the breasts are almost entirely fatty, or that there are scattered areas of fibroglandular density, the summary includes the statement that breast tissue can be dense or not dense, that dense tissue makes cancer harder to find on a mammogram and raises the risk of developing breast cancer, and that the patient's breast tissue is not dense. If the report says heterogeneously dense or extremely dense, the statement says the patient's tissue is dense, adds that other imaging tests in addition to a mammogram may help find cancers in some people with dense tissue, and tells the patient to talk with a healthcare provider. Both end by advising the patient to talk to a healthcare provider about density, risks, and the individual situation.
Why it matters
Four report categories lead to two patient statements. The regulation prescribes the statements, so the safe practice is to insert them exactly as written for each category.
What it means to the patient or the client
For patients: the letter tells you in plain words whether your breast tissue is dense, and that you can talk with your healthcare provider about it. For the practice: the statement depends on the density category in the report, so a template that links the two prevents the wrong statement going out.
Sources
21 CFR §900.12. Quality standards. eCFR. Accessed October 7, 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-I/part-900/subpart-B/section-900.12 View source (accessed October 7, 2026)
21 CFR 900.12(c)(2) sets the minimum content of the lay summary a facility gives each patient.
How it works
At a minimum the summary includes the patient's name, the name, address, and telephone number of the facility that performed the examination, and an assessment of breast density using the statements set out in 21 CFR 900.12(c)(2)(iii) and (iv). It must be written in lay terms.
Why it matters
Missing one of these elements is an easy finding at inspection. A template that fills the facility's name, address, and telephone number and inserts the correct density statement each time keeps every letter compliant.
What it means to the patient or the client
For patients: the letter shows your name and the name, address, and telephone number of the facility, so you know whom to call with questions. For the practice: an inspector can check these elements quickly, so build them into the template once.
Sources
21 CFR §900.12. Quality standards. eCFR. Accessed October 7, 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-I/part-900/subpart-B/section-900.12 View source (accessed October 7, 2026)
Each facility must give every patient a summary of the mammography report written in lay terms (21 CFR 900.12(c)(2)).
How it works
The summary is due within 30 calendar days of the mammographic examination. If the assessment is Suspicious or Highly Suggestive of Malignancy, it is due within 7 calendar days of the final interpretation of the mammograms. A patient who names no healthcare provider also receives the full mammography report, on the same timing.
Why it matters
The two clocks start at different points: 30 days from the examination, and 7 days from the final interpretation. Letter workflows that track both dates avoid late letters for the cases that matter most.
What it means to the patient or the client
For patients: you should receive a plain language summary within 30 days of your exam, and within 7 days of the final interpretation if the result is Suspicious or Highly Suggestive of Malignancy. For the practice: track the two clocks separately so the urgent letters never wait on the 30 day schedule.
Sources
21 CFR §900.12. Quality standards. eCFR. Accessed October 7, 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-I/part-900/subpart-B/section-900.12 View source (accessed October 7, 2026)
When a patient has a referring healthcare provider, or names one, the facility must send that provider the written mammography report (21 CFR 900.12(c)(3)).
How it works
The report, with the items listed for mammography reports, is due as soon as possible and no later than 30 days from the date of the examination. If the assessment is Suspicious or Highly Suggestive of Malignancy, the report is due within 7 calendar days of the final interpretation, to the referring provider or, if unavailable, to a responsible designee of that provider.
Why it matters
The designee provision matters when the referring provider is away. Naming a backup recipient in the referral record helps meet the 7 day deadline.
What it means to the patient or the client
For patients: your provider receives the written report within 30 days, or within 7 days of the final interpretation for a suspicious or highly suggestive result, so your next step can be planned. For the practice: record a backup recipient for each referring provider so the 7 day deadline can be met when the provider is away.
Sources
21 CFR §900.12. Quality standards. eCFR. Accessed October 7, 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-I/part-900/subpart-B/section-900.12 View source (accessed October 7, 2026)
