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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Separate Assessment of Findings for Each Breast

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FDA approved this alternative standard July 3, 2003 for an indefinite period. It allows the interpreting physician to provide a separate assessment of findings for each breast in the medical report, without the need to also provide an overall assessment of findings. Therefore, the interpreting physician can choose between providing separate assessments under this alternative or providing an overall assessment for the examination under the original standard.

The original standard is 21 CFR 900.12(c)(1)(iv), which states:

21 CFR 900.12(c)(1): Medical records and mammography reports (iv) Overall final assessment of findings, classified in one of the following categories:

The approved alternative is:

21 CFR 900.12(c)(1): Medical records and mammography reports (iv) A separate assessment findings for each breast, classified in one of the following categories:

When this alternative is used, the following conditions apply.

  • A single medical report covering the assessment of both breasts will be sent to the referring physician (or to the patient if there is no referring physician;
  • A single lay report will be sent to the patient, containing information based on the overall assessment for both breasts; and
  • Even though separate assessments are made for each breast, the interpretation will count as only one examination towards meeting the MQSA experience requirements and will be billed as a single examination.