Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled "Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide." The Mammography Quality Standards Act of 1992 (MQSA) final rule amended FDA's regulations to address, among other things, standards for accreditation bodies, certifying agencies, mammography equipment, quality assurance testing, and clinical image quality, as well as to require certain breast density information be provided by mammography facilities to patients and their healthcare providers. The small entity compliance guide (SECG) is intended to help small entities comply with the MQSA final rule.