Quality Mammography Standards: Final Rule Amending 21 CFR Part 900 (FR Doc. 99–9222)
64 FR 18331 · Docket No. 98N-0728 · Effective April 28, 1999
Last Reviewed: August 21, 2026
- Publisher
- U.S. Food and Drug Administration / Federal Register
- Author
- William K. Hubbard, Acting Deputy Commissioner for Policy, FDA
- Edition
- Final Rule — 64 FR 18331, 1999
- Pages
- 3 pages
- Added to library
- Added August 21, 2026
Overview
This Federal Register final rule (Vol. 64, No. 71, April 14, 1999) amends two sections of the MQSA quality standards regulation (21 CFR Part 900) to resolve a design conflict discovered after the comprehensive MQSA final rule was published October 28, 1997 (62 FR 55852). The 1997 rule required that the x-ray field 'extend to or beyond the edges of the image receptor,' a provision that conflicted with existing EPRC performance standards requiring manufacturers to limit collimation so the x-ray field does not extend beyond the nonchest wall edges. Several manufacturers had already designed systems to meet the EPRC standard, meaning those systems would have been non-compliant with the MQSA regulation as written. This 1999 amendment (1) makes it permissible (but no longer mandatory) for the x-ray field to extend to nonchest wall edges, (2) applies the 2% of SID extension limit uniformly to all edges of the image receptor (correcting an omission that applied it only to the chest wall side), and (3) consolidates all alignment requirements into §900.12(e)(5)(vii)(A), removing alignment language from §900.12(b)(5) while preserving the light field illumination requirement.
Key Contents
-Regulatory action: Final rule amending 21 CFR Part 900 | Docket No. 98N-0728 | FR Doc. 99–9222
-Published: Federal Register Vol. 64, No. 71 (April 14, 1999), pages 18331–18333
-Effective date: April 28, 1999 (same effective date as the main MQSA final rule, 62 FR 55852)
-Signed by: William K. Hubbard, Acting Deputy Commissioner for Policy, April 7, 1999
-Sections amended:
• §900.12(b)(5) Light fields: retained illumination standard (160 lux at 100 cm or max SID); alignment language removed and consolidated below
• §900.12(e)(5)(vii)(A) Beam-limiting devices: revised to require (a) chest wall edge of x-ray field reaches chest wall edge of image receptor AND (b) x-ray field does not extend beyond ANY edge of image receptor by more than 2% of SID
-Two problems corrected:
1. Collimation conflict: The 1997 rule required the x-ray field to extend to or beyond image receptor edges, but EPRC standards required manufacturers to limit collimation below those edges. Amended rule makes reaching the nonchest wall edges permissible, not mandatory.
2. SID limit omission: The 2% of SID extension limit had been applied only to the chest wall side. Corrected to apply to all edges of the image receptor.
-Background: MQSA enacted October 27, 1992 (Pub. L. 102–539); interim rules 58 FR 67558 and 58 FR 67565 (December 21, 1993); comprehensive final rule 62 FR 55852 (October 28, 1997)
-Proposed amendment published November 5, 1998 (63 FR 59750); two public comments received, both supportive
-Economic impact: No significant negative impact on small entities; no Unfunded Mandates Reform Act threshold triggered
-No Paperwork Reduction Act burden: no new information collections
-Contact: Roger L. Burkhart, CDRH (HFZ-240), FDA, 1350 Piccard Dr., Rockville, MD 20850 | 301–594–3332
How This Applies to Your Practice
This amendment established and codified the operative 21 CFR § 900.12(e)(5)(vii)(A) language that MQSA inspectors use today when evaluating beam-limiting device and collimation compliance. The corrected two-part requirement, (a) the x-ray field must reach the chest wall edge of the image receptor AND (b) the x-ray field must not extend beyond any edge of the image receptor by more than 2% of the SID, is a standard quality control test item in the medical physicist's annual survey and the technologist's routine QC checklist. When facilities or physicists reference the operative text of 21 CFR Part 900 on beam-limiting device collimation, they are relying on language as amended April 28, 1999, not the original 1997 final rule text at 62 FR 55852. This distinction matters if a facility contests an inspection finding related to x-ray field alignment: the applicable citation is § 900.12(e)(5)(vii)(A) as amended by this rule, and the pre-amendment language requiring the x-ray field to 'extend to or beyond the edges of the image receptor' was explicitly superseded. QC manuals, physicist annual survey reports, and compliance documentation that cite collimation standards should confirm they reflect the post-amendment requirement.
Practitioner Implications
Medical physicists conducting MQSA annual surveys must apply the two-part collimation standard from § 900.12(e)(5)(vii)(A) as amended: (1) the x-ray field must reach the chest wall edge of the image receptor, and (2) the x-ray field must not extend beyond any edge by more than 2% of the SID. The 2% limit applies to all four edges of the image receptor, not only the chest wall side; this was the specific omission corrected by this 1999 rule. Technologists performing routine QC should confirm that any collimation-related test in the facility's QC manual reflects both conditions. If a QC manual references only the chest wall alignment requirement without the all-edges 2%-of-SID limit, it predates this amendment and needs updating. Facilities that have received past inspection findings related to x-ray field alignment should verify that the inspector cited the post-April 28, 1999 text. The pre-amendment version of § 900.12(e)(5)(vii)(A), which required the field to 'extend to or beyond the edges of the image receptor', was superseded by this rule and should not appear in current compliance documentation, QC manuals, or physicist survey reports.
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