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21 CFR § 900.1 - Scope.

---
identifier: "/us/cfr/t21/s900.1"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 900.1 - Scope."
title_number: 21
title_name: "Food and Drugs"
section_number: "900.1"
section_name: "Scope."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "I"
subchapter_name: "MAMMOGRAPHY QUALITY STANDARDS ACT"
part_number: "900"
part_name: "MAMMOGRAPHY"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b."
regulatory_source: "62 FR 55976, Oct. 28, 1997, unless otherwise noted. Republished and corrected at 62 FR 60614, Nov. 10, 1997."
cfr_part: "900"
---

# 900.1 Scope.

The regulations set forth in this part implement the Mammography Quality Standards Act (MQSA) (42 U.S.C. 263b). Subpart A of this part establishes procedures whereby an entity can apply to become a Food and Drug Administration (FDA)-approved accreditation body to accredit facilities to be eligible to perform screening or diagnostic mammography services. Subpart A further establishes requirements and standards for accreditation bodies to ensure that all mammography facilities under the jurisdiction of the United States are adequately and consistently evaluated for compliance with national quality standards for mammography. Subpart B of this part establishes minimum national quality standards for mammography facilities to ensure safe, reliable, and accurate mammography. The regulations set forth in this part do not apply to facilities of the Department of Veterans Affairs.