Highlights of the 2023 Amendments to the MQSA Implementing Regulations.

Abstract

The Mammography Quality Standards Act (MQSA) of 1992 is intended to ensure that mammography practice nationwide meets consistent baseline quality standards. Amendments to the MQSA implementing regulations ("Amendments") were published on March 10, 2023, and are effective on September 10, 2024. The Amendments address various aspects of the program, including mammography technology, enforcement, the retention and transfer of personnel records and medical records, the medical outcomes audit, and mammography reporting, including (but not limited to) reporting of breast tissue density. The amended regulations are available online, and the Food and Drug Admininstration (FDA) offers several resources for mammography facilities and other stakeholders to receive additional information, including a facility hotline, a summary document distributed to all certified mammography facilities, and a Small Entity Compliance Guide (or SECG) written in question-and-answer format, which the FDA intends to be helpful to facilities of any size.