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(c)(2) has two rules for patients who do not name a healthcare provider to receive the mammography report.
How it works
The patient receives the full mammography report, as well as the written lay summary of the results, within 30 days. If the assessment is Suspicious or Highly Suggestive of Malignancy, the report goes to the patient within 7 calendar days of the final interpretation of the mammograms. Each facility that accepts patients without a healthcare provider must also maintain a system for referring them to a healthcare provider when clinically indicated, which must include cases where the assessment is Probably Benign, Suspicious, or Highly Suggestive of Malignancy.
Why it matters
For these patients the facility is the only recipient of the result, so the report timing and the referral system are the safety net.
What it means to the patient or the client
For patients: if you have no healthcare provider, the facility must still send you your results and help connect you with a provider when your result calls for it. For the client: document your referral process and test it for the three assessment categories.
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)
