Section 325.5668. Quality assurance - mammography medical outcomes audit; mammographic procedure and techniques for mammography of patients with breast implants; consumer complaint mechanism; and clinical image quality.  


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  • A mammography facility shall comply with 21 C.F.R. 900.12 (f), “Quality assurance mammography medical outcomes audit” (2000); 21 C.F.R. 900.12 (g), “Mammographic procedure and techniques for mammography of patients with breast implants” (2000); 21 C.F.R. 900.12 (h), “Consumer complaint mechanism” (2000) and 21 C.F.R. 900.12 (i), “Clinical image quality”  (2000).

History: 2013 AACS.