21 CFR Part 900: Mammography
Source: eCFR · Current as of October 1, 2026
Last Reviewed: October 5, 2026
- Publisher
- Electronic Code of Federal Regulations (eCFR), National Archives and Records Administration and U.S. Government Publishing Office
- Author
- U.S. Food and Drug Administration
- Edition
- eCFR, current as of October 1, 2026. Checked against the official CFR annual edition revised April 1, 2025., 2026
- Added to library
- Added October 5, 2026
Overview
Part 900 is the operative rule book for every FDA-certified mammography facility. Subpart A (sections 900.1 to 900.7) sets out how accreditation bodies are approved, evaluated, and withdrawn. Subpart B (sections 900.10 to 900.18) sets the requirements for certification and the quality standards facilities must meet, with section 900.12 carrying most of the day-to-day obligations: personnel qualifications, equipment, medical records and mammography reports, quality assurance, the medical outcomes audit, the consumer complaint mechanism, clinical image quality, and additional mammography review and notification. Subpart C (sections 900.20 to 900.25) covers States that act as certifiers. The complete text is held in the MammoLibrary for search and citation, and this page describes how Part 900 is organized. It is not an interpretation of the regulation. Read the text itself on the eCFR at https://www.ecfr.gov/current/title-21/part-900.
Key Contents
-Source: Electronic Code of Federal Regulations (eCFR), Title 21, Part 900 (Mammography)
-Read the full text: https://www.ecfr.gov/current/title-21/part-900
-Official edition: Code of Federal Regulations, Title 21, annual edition revised April 1, 2025 (govinfo.gov). The 2026 annual edition was not yet published when this item was prepared.
-Checked against the official 2025 edition word for word: the wording matches. Differences are typographic only (quotation mark style, small capitals, and one page range hyphen), plus the layout of the two tables in section 900.12(e), whose numbers match.
-Current as of: October 1, 2026 (eCFR reported Title 21 up to date as of that date)
-Most recent amendment to a Part 900 section shown in the eCFR version history: September 10, 2024
-Authority: 21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b
-Original source: 62 FR 55976, October 28, 1997, republished and corrected at 62 FR 60614, November 10, 1997
-Subpart A, Accreditation: 900.1 Scope; 900.2 Definitions; 900.3 Application for approval as an accreditation body; 900.4 Standards for accreditation bodies; 900.5 Evaluation; 900.6 Withdrawal of approval; 900.7 Hearings
-Subpart B, Quality Standards and Certification: 900.10 Applicability; 900.11 Requirements for certification; 900.12 Quality standards; 900.13 Revocation of accreditation; 900.14 Suspension or revocation of certificates; 900.15 Appeals of adverse accreditation or reaccreditation decisions; 900.16 Appeals of denials of certification; 900.18 Alternative requirements for 900.12 quality standards
-Subpart C, States as Certifiers: 900.20 Scope; 900.21 Application for approval as a certification agency; 900.22 Standards for certification agencies; 900.23 Evaluation; 900.24 Withdrawal of approval; 900.25 Hearings and appeals
-Section 900.12 paragraph headings: (a) Personnel; (b) Equipment; (c) Medical records and mammography reports; (d) Quality assurance, general; (e) Quality assurance, equipment; (f) Quality assurance, mammography medical outcomes audit; (g) Mammographic procedure and techniques for mammography of patients with breast implants; (h) Consumer complaint mechanism; (i) Clinical image quality; (j) Additional mammography review and patient and referring provider notification
-Sections 900.8, 900.9, and 900.17 are reserved
-Cite by section, for example 21 CFR 900.12(f)
How This Applies to Your Practice
Mammologix supports facilities with the work that Part 900 requires of them, including medical outcomes audit support under section 900.12(f), lay letter and report timeliness under section 900.12(c), and inspection readiness. This item gives readers and the Mammologix library the regulation text itself, so that articles, policies, and answers can point to the exact section rather than to a summary of it. The 2023 final rule (88 FR 15126), also in the MammoLibrary, is the amending document that took full effect on September 10, 2024. Part 900 as shown here is the consolidated result.
Practitioner Implications
Treat this item as a reference copy, not as legal advice or an interpretation. The text is from the eCFR, current as of the date shown, and was checked against the official 2025 annual edition of the Code of Federal Regulations (revised April 1, 2025). The official legal text is the Code of Federal Regulations on govinfo.gov and the Federal Register. The eCFR is updated continuously, so before relying on a requirement for a facility decision, check the live eCFR and the FDA MQSA program pages for later changes, and consult the facility's accreditation body, state agency, or counsel where the answer matters. Mammologix articles and tools that cite a section of Part 900 should name the section and the current-as-of date shown here.
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