GuidanceU.S. Department of Health and Human Services / Federal Register · 1998 · 1 pp.
This 1-page Federal Register notice (63 FR 9555, February 25, 1998, FR Doc. 98-4723) is Secretary Donna E. Shalala's formal delegation of all MQSA authority to the Commissioner of Food and Drugs, a foundational administrative act establishing FDA's legal standing to administer the entire MQSA inspection, certification, and accreditation program. Effective February 11, 1998, the delegation supersedes the original June 1, 1993 delegation from the Acting Assistant Secretary for Health and retroactively affirms all MQSA actions taken by FDA or its subordinates prior to that date, formally validating nearly five years of MQSA implementation activity.
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Read document →GuidanceU.S. Food and Drug Administration / Federal Register · 2007 · 3 pp.
This 3-page Federal Register notice (72 FR 37027, July 6, 2007, Docket No. 2007N-0238) announces FDA's updated MQSA inspection fee schedule effective October 1, 2007, the first increase since the 2003 fee notice (68 FR 5289). Driven by a resource review showing recoverable inspection costs had grown to an estimated $15.77 million for FY2008, FDA raised the annual inspection fee for a one-unit facility from $1,749 to $2,150, using a $1,900 base facility charge plus $250 per mammography unit, and raised the follow-up inspection fee to $1,144. The notice also adds a critical clarification absent from prior fee notices: Medicare/Medicaid provider status alone does not qualify a facility as a governmental entity exempt from inspection fees.
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Read document →GuidanceU.S. Food and Drug Administration / Federal Register · 1998 · 4 pp.
This 4-page Federal Register notice (63 FR 2245, January 14, 1998, Docket No. 94N-0335) announces the first increase in MQSA inspection fees since the program's inception in January 1995. Effective February 13, 1998, FDA raised the annual inspection fee for a one-unit facility from $1,178 to $1,549 and set the follow-up inspection fee at $878 flat, to recover the estimated $12.8 million in aggregate FY1998 inspection program costs. The notice details which facilities are subject to the fee, how the per-facility-plus-per-unit methodology works, the billing and collection process, and the governmental entity exemption criteria under 42 U.S.C. 263b(r).
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Read document →GuidanceU.S. Food and Drug Administration / Federal Register · 2010 · 54 pp.
This 54-page Federal Register notice (75 FR 48180, August 9, 2010, Docket No. FDA-1998-N-0050) is FDA's comprehensive registry of all guidance documents active across every Center and Office within the agency as of April 2010, published under Good Guidance Practices (GGPs) at 21 CFR 10.115. For MQSA facilities, the Center for Devices and Radiological Health (CDRH) section identifies which mammography quality standards guidance documents were operative, recently added, or withdrawn in the five-year period preceding publication, establishing a historical benchmark for tracing how the regulatory guidance landscape evolved toward current MQSA compliance requirements.
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Read document →GuidanceU.S. Food and Drug Administration / Federal Register · 2026 · 11 pp.
FDA proposed rule published August 10, 2026, proposing to reclassify digital breast tomosynthesis (DBT) systems (product code OTE) from class III (premarket approval) to class II (special controls), subject to premarket notification (510(k)). Proposes a new device classification regulation at 21 CFR §892.1717 with special controls addressing performance testing, clinical image evaluation, software verification, biocompatibility, and labeling. Comments due October 9, 2026. DBT is a mammographic modality under MQSA; facilities performing DBT screening remain subject to all MQSA requirements regardless of the device's regulatory classification.
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Read document →GuidanceU.S. Food and Drug Administration / Federal Register · 1995 · 22 pp.
1995 FDA final rule creating 21 CFR Part 17: the comprehensive hearing procedures governing all FDA administrative civil money penalty proceedings. Implements the civil money penalty authority granted by five statutes including the Mammography Quality Standards Act of 1992 (MQSA), establishing the procedural framework used when FDA proposes to impose CMP sanctions on mammography facilities for failure to obtain a certificate, failure to comply with established standards, or other MQSA violations.
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Read document →GuidanceU.S. Food and Drug Administration / Federal Register · 1995 · 3 pp.
1995 FDA final rule amending 21 CFR §5.85 to redelegate the Commissioner's authority under the Mammography Quality Standards Act (MQSA, Pub. L. 102-539) to three CDRH officials: Director and Deputy Director for Regulations and Policy; Director of the Office of Health and Industry Programs; and Director of the Division of Mammography Quality and Radiation Programs. Establishes the organizational legal foundation for all CDRH actions to certify facilities, approve accreditation bodies, conduct inspections, impose sanctions, and suspend or revoke certificates.
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Read document →GuidanceU.S. Food and Drug Administration / Federal Register · 1998 · 5 pp.
FDA correcting amendment to 21 CFR Part 900 published October 22, 1998, fixing 12 typographical and substantive errors in the comprehensive MQSA final rule (62 FR 55852, October 28, 1997). Corrections span personnel qualification requirements, the compression force limit (corrected from 209 to 200 newtons / 45 lbs), quality assurance records, the medical outcome audit reviewing physician obligation, and the list of tests requiring corrective action before further clinical use.
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Read document →GuidanceU.S. Food and Drug Administration / Federal Register · 1999 · 3 pp.
1999 FDA final rule amending 21 CFR Part 900 §900.12 to resolve a conflict between MQSA mammography facility regulations and FDA's Electronic Product Radiation Control (EPRC) performance standards for x-ray equipment. Corrects x-ray field collimation and beam-limiting device alignment requirements so that facilities using EPRC-compliant equipment are not inadvertently placed out of MQSA compliance.
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Read document →GuidanceU.S. Food and Drug Administration / Federal Register · 2021 · 4 pp.
FDA's consolidated Notice of Availability (NOA) for four COVID-19 Public Health Emergency guidance documents issued in late 2020, published January 4, 2021 (Federal Register Vol. 86, No. 1). The document of primary interest to mammography facilities is the CDRH guidance: 'Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act [MQSA] During the COVID-19 Public Health Emergency (December 2020),' which established temporary compliance flexibilities for facilities facing pandemic-related disruptions to inspections and medical physicist surveys.
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Read document →GuidanceU.S. Food and Drug Administration / Federal Register · 2025 · 1 pp.
FDA notice announcing that effective October 1, 2025, the Agency will no longer accept paper-based payment methods (checks, bank drafts, or money orders) for any federal payments or collections. All transactions must be conducted electronically via ACH, credit card, wire transfer, or Pay.gov, except where a statutory exemption or waiver applies. This change affects all FDA user fee programs, including MQSA.
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Read document →GuidanceU.S. Food and Drug Administration / Federal Register · 2024 · 2 pp.
The FDA's official announcement that the Small Entity Compliance Guide (SECG) for the 2024 MQSA Final Rule is available. Published August 26, 2024, this Federal Register notice confirms the SECG as an FDA Level 2 guidance document (non-binding but representing the Agency's current thinking) intended to help mammography facilities, accreditation bodies, and certifying agencies comply with the MQSA regulations effective September 10, 2024.
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Read document →GuidanceU.S. Food and Drug Administration / Federal Register · 2023 · 46 pp.
The FDA's landmark 2024 update to MQSA regulations: the most significant revision in over 20 years. Published March 10, 2023 and effective September 10, 2024, this final rule mandates breast density notification in patient lay summaries, standardizes four BI-RADS density categories in mammography reports, strengthens the medical outcomes audit, and adds new enforcement tools for noncompliant facilities.
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Read document →ManualDoctrinaEdge Publishing · 2025 · 30 pp.
A practical manual guiding mammography facilities through the 2024 MQSA requirements effective September 10, 2024. Covers personnel qualifications, equipment QC, EQUIP, medical outcomes audits, patient communications including density notifications, recordkeeping, and a detailed inspection checklist. Emphasizes continuous readiness over one-time preparation.
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