Radiation-Emitting Products

MQSA Alternative Standard #11: Modifications in the Assessment Categories Used in Medical Reports

FDA approved two alternative requirements dealing with the content of the medical report on August 29, 2003. They became effective on that date. They do not have a time limit. One of these adds a new assessment category for use in the reports of the mammography examinations and also adds clarifying language to the existing assessment categories. The second adds a reference to the possible need to obtain prior mammograms in order to make a final assessment.

The original standards are 21 CFR 900.12(c)(1)(iv) and (v), which state:

21 CFR 900.12(c)(1): Medical records and mammography reports …..

(iv) Overall assessment of findings, classified in one of the following categories:
(A) "Negative:" Nothing to comment upon (if the interpreting physician is aware of clinical findings or symptoms, despite the negative assessment, these shall be explained)";
(B) "Benign:" Also a negative assessment;
(C) "Probably Benign:" Finding(s) has a high probability of being benign;
(D) "Suspicious:" Finding(s) without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant;
(E) "Highly suggestive of malignancy:" Finding(s) has a high probability of being malignant:
(v) In cases where no final assessment category can be assigned due to incomplete work-up, "Incomplete: Need additional imaging evaluation" shall be assigned as an assessment and reasons why no assessment can be made shall be stated by the interpreting physician; and...

The approved alternatives are:

21 CFR 900.12(c)(1): Medical records and mammography reports…..

(iv) Overall assessment of findings, classified in one of the following categories:
(A) "Negative:" Nothing to comment upon (if the interpreting physician is aware of clinical findings or symptoms, despite the negative assessment, these shall be explained)";
(B) "Benign Finding(s):" Also a negative assessment;
(C) "Probably Benign Finding(s):" Initial short-interval follow-up suggested. Finding(s) has a high probability of being benign;
(D) "Suspicious Abnormality:" Biopsy should be considered. Finding(s) without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant;
(E) "Highly suggestive of malignancy:" Appropriate action should be taken. Finding(s) has a high probability of being malignant:
(F) "Known Biopsy Proven Malignancy:" Appropriate action should be taken.
(v) In cases where no final assessment category can be assigned due to incomplete work-up, "Incomplete: Need additional imaging evaluation and/or prior mammograms for comparison" shall be assigned as an assessment and reasons why no assessment can be made shall be stated by the interpreting physician; and...

As was the case with the original standard, only the words in quotation marks are required to be included in the medical report when giving the assessment category or indicating that no final category can be assigned at the present time. The remaining language is intended to provide explanations of the categories in order to promote their consistent use. It is not required to be included in the medical report, although the interpreting physician may do so if he or she wishes.

Back to Alternative Standards (MQSA)

Page Last Updated: 09/25/2014
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