The American College of Radiology (ACR) submitted comments in response to a Food and Drug Administration (FDA) Notice of Proposed Rulemaking (NPRM) that proposes to amend current Mammography Quality Standards Act (MQSA) regulations.
The ACR’s comments were developed with input from a broad representation of relevant ACR commissions, committees and interested members. Among the issues addressed in ACR’s comments were retention and provision of facility personnel records, breast density reporting, equipment and quality control, mammographic assessment categories, mammography medical outcomes audits and other issues.
The U.S. Food and Drug Administration will consider the comments received in response to the NPRM and will likely make significant changes to the proposed rule before publishing it in its final form. That process is expected to take several months. The ACR will continue to provide updates on this issue as new information becomes available.
For more information, contact Gloria Romanelli, JD, ACR senior director of legislative and regulatory affairs.