August 8, 2016 — The U.S. Food and Drug Administration’s (FDA) National Mammography Quality Assurance Advisory Committee is considering new measures to improve breast imaging quality and how breast density impacts exams. The panel will discuss these and other items at its next meeting Thursday, Sept. 15, 2016, in Gaithersburg, Md.
The committee provides advice and recommendations to the FDA on agency’s regulatory issues.
The committee will discuss and make recommendations on compliance analysis, focusing on the Mammography Quality Standards Act (MQSA) current compliance trends. The discussion will include trends seen in the analysis, why the trends may be occurring and possible actions that should be sought.
The panel will also discuss the Inspection Enhancement Project, which is proposes to use the inspection program to enhance breast image quality. FDA is seeking committee input on anticipated facility questions related to the proposal. The approved alternative standard American College of Radiology Full Field Digital Mammography Quality Control Manual contents will be explained and FDA will ask the committee's advice on facility roll-out strategies.
The committee will also address issues related to breast density (fibroglandular densities). A presentation will examine the current issues, followed by a committee discussion on how these issues might effect a possible MQSA requirement for reporting breast density. Future challenges for MQSA include the role of synthesized 2-D images created from 3-D tomosynthesis mammography datasets. The FDA is seeking committee input on this challenge, as well as what future challenges MQSA might encounter.
For more informtion: www.fda.gov/AdvisoryCommittees/Calendar/ucm515098.htm