R 333.5668 Quality assurance - mammography medical outcomes audit; mammographic procedure and techniques for mammography of patients with breast implants; consumer complaint mechanism; clinical image quality.

Rule 668. 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).