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.
21 CFR 900.12(f)(1) requires a facility to run a system that follows up on positive mammographic assessments and correlates pathology results with the interpreting physician's findings.
How it works
The facility must establish a system to collect and review outcome data for all mammographic examinations performed. That includes follow-up on the disposition of all positive mammograms and correlation of pathology results with the interpreting physician's mammography report. The data feeds the medical outcomes audit, which is analyzed for each interpreting physician and for the facility together.
Why it matters
The rule requires follow-up on every positive mammogram, not a sample. A positive mammogram with no recorded disposition is a gap in the audit.
What it means to the patient or the client
For patients: this is why a facility keeps track of what happened after an abnormal mammogram. For the client: every positive result needs a recorded outcome, including results from outside facilities and pathology labs.
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(f)(1) has a rule for cases of breast cancer among a facility's patients that the facility learns about afterward.
How it works
When breast cancer among patients imaged at the facility subsequently becomes known to the facility, the facility must promptly initiate follow-up on surgical and pathology results. It must also review the mammographic examinations taken before the diagnosis of the malignancy.
Why it matters
The review of earlier mammograms is part of the audit loop: it shows how the facility's interpretations related to the cancer that was later found.
What it means to the patient or the client
For the client: set up a way for outside diagnoses to reach your audit, assign the follow-up on surgical and pathology results, and record the review of the earlier mammograms.
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)
