Quality Mammography Standards: Correcting Amendment to 21 CFR Part 900 (FR Doc. 98-28148)
63 FR 56555 · Docket No. 95N-0192 · Effective April 28, 1999
Last Reviewed: August 21, 2026
- Publisher
- U.S. Food and Drug Administration / Federal Register
- Author
- William K. Hubbard, Associate Commissioner for Policy Coordination, FDA
- Edition
- Final Rule — 63 FR 56555, 1998
- Pages
- 5 pages
- Added to library
- Added August 21, 2026
Overview
This five-page Federal Register final rule (Vol. 63, No. 204, October 22, 1998) is the definitive correcting amendment to the comprehensive MQSA quality standards rule published October 28, 1997 (62 FR 55852), itself partly corrected in a republication of November 10, 1997 (62 FR 60614) that introduced additional errors. The 1998 correcting amendment addresses 12 distinct problems across eight sections of 21 CFR Part 900: definitions (§900.2(d)), personnel qualifications (§900.12(a)(2)(ii), (a)(2)(iv)(A), (a)(3)(iii)(B)), records (§900.12(c)(4)(i), (c)(4)(ii), (d)(2)), equipment QC (§900.12(e)(1), (e)(4)(iii)(B), (e)(8)(ii)(A), (e)(10)), and the medical outcome audit (§900.12(f)(3)). Effective April 28, 1999 for most provisions, with §900.12(e)(4)(iii)(B) (compression force limit) effective October 28, 2002. Signed by William K. Hubbard, Associate Commissioner for Policy Coordination, October 6, 1998.
Key Contents
-Regulatory action: Final rule; correcting amendment | Docket No. 95N-0192 | FR Doc. 98-28148 | RIN 0910-AA24
-Published: Federal Register Vol. 63, No. 204 (October 22, 1998), pages 56555–56559
-Effective date: April 28, 1999 (except §900.12(e)(4)(iii)(B): October 28, 2002)
-Signed: William K. Hubbard, Associate Commissioner for Policy Coordination, October 6, 1998
-Contact: Roger L. Burkhart, CDRH (HFZ-240), FDA, 1350 Piccard Dr., Rockville, MD 20850 | 301-594-3332
-12 corrections across 8 sections:
A. §900.2(d): Air kerma definition
Fixed editorial error conflating 'rad' with 'radian'; clarified that in air, 1 Gy of absorbed dose is delivered by 114 roentgens (R) of exposure.
B. §900.12(a)(2)(ii): Technologist mammography requirements (grandparenting provision)
Added 'of FDA's interim regulations' to eliminate ambiguous cross-reference to paragraph (a)(2), clarifying that grandparenting applies to interim (not final) regulations.
C. §900.12(a)(2)(iv)(A): Technologist continuing experience
Date changed from October 28, 1997 (publication date) to April 28, 1999 (effective date) to prevent retroactive application; 'preceding the inspection' added to the calendar quarter reference. Compliance checking begins after June 30, 2001.
D. §900.12(a)(3)(iii)(B): Medical physicist continuing experience
'on' corrected to 'or' in the survey requirement; 'the total mammography units survey' replaced with 'this'; date corrected from October 28, 1997 to April 28, 1999; 'preceding the inspection' added.
OPERATIVE TEXT: Physicist must survey ≥2 facilities and ≥6 total units in the 24 months preceding annual MQSA inspection. No more than one survey of a specific facility within 10 months, or a specific unit within 60 days, may count.
E. §900.12(c)(4)(i): Maintenance of records
Cross-reference corrected from '(c)(3)(ii)' to '(c)(4)(ii)': a citation error with significant compliance consequences.
F. §900.12(c)(4)(ii): Transfer of records
'by' moved to correct position; facility must transfer mammograms 'on behalf of' the patient, not the previous garbled phrasing.
G. §900.12(d)(2): Quality assurance records
'Employee qualifications to meet assigned quality assurance tasks' moved to last position in the records list (was first, creating two possible interpretations). 'These' changed to 'the' in the second sentence.
H. §900.12(e)(1): Daily quality control tests
'Examinations' → 'films' and 'performed' → 'processed' completed for second occurrence in paragraph (first set had been corrected in November 1997 republication).
I. §900.12(e)(4)(iii)(B): Compression force (effective October 28, 2002)
CRITICAL: Upper limit corrected from 209 newtons (47 lbs) to 200 newtons (45 lbs). The maximum compression force from the initial power drive must be between 111 newtons (25 lbs) and 200 newtons (45 lbs).
J. §900.12(e)(8)(ii)(A): Tests requiring corrective action before further clinical use
Section citations corrected. Tests triggering mandatory pre-use corrective action: §900.12(e)(1), (e)(2), (e)(4)(i), (e)(4)(ii), (e)(4)(iii), (e)(5)(vi), (e)(6), or (e)(7).
K. §900.12(e)(10): Mammography equipment evaluations
'Dissembled' corrected to 'disassembled.'
L. §900.12(f)(3): Reviewing interpreting physician (medical outcome audit)
Comma replaced with 'and for': corrects incomplete sentence. Reviewing physician is responsible for: (1) documenting the results AND (2) notifying other interpreting physicians of their results and facility aggregate results.
How This Applies to Your Practice
This correcting amendment contains several provisions with direct, ongoing compliance implications that MQSA inspectors still evaluate. The compression force correction (correction I), 200 newtons / 45 lbs maximum from the power drive, remains the active regulatory standard and is a routine QC test item. The medical physicist continuing experience correction (correction D) defines the operative language governing physicist qualification: ≥2 facilities, ≥6 units, 24 months preceding the annual MQSA inspection. The records transfer correction (correction F) governs how facilities must respond to patient mammogram requests. The medical outcome audit correction (correction L) established the reviewing interpreting physician's obligation to notify other physicians of their individual results: an inspection-verified requirement. Facilities and MammoComply users should note that the version of 21 CFR Part 900 they reference must incorporate these 1998 corrections, as errors in the 1997 original text created compliance traps.
Practitioner Implications
Key active compliance items corrected by this document: (1) Maximum compression force from power drive is 200 newtons (45 lbs), not 209 newtons; (2) Medical physicist must survey ≥2 facilities and ≥6 units in 24 months preceding the annual MQSA inspection, no more than one survey of a specific facility in 10 months or a specific unit in 60 days; (3) Reviewing interpreting physician must both document medical outcome audit results AND notify other interpreting physicians of their individual and aggregate results; (4) Records transfer citation in §900.12(c)(4)(i) correctly references §900.12(c)(4)(ii). Facilities and physicists using the original October 28, 1997 final rule text without these corrections are working from an erroneous regulatory source.
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