The U.S. Food and Drug Administration issued a proposed rule on March 27 that would make amendments to the regulations issued under the Mammography Quality Standards Act (MQSA) of 1992 that seek to improve the quality of mammography services. The proposed rule would expand the information mammography facilities are required to provide to patients and healthcare professionals to allow for more informed medical decision-making, the agency said in a statement. It also modernizes mammography quality stands and strengthens the FDA’s ability to enforce regulations that apply to the safety and quality of mammography services.
Under the proposed rule, breast density information would be added to the mammography lay summary letter provided to patients and to the medical report provided to their referring healthcare professionals.
The amendments would also expand the information provided to healthcare professionals by proposing to codify three additional categories for the assessments of mammograms, including adding an important category titled “known biopsy proven malignancy,” which would help identify for healthcare professionals those cases where cancer being mammographically evaluated for therapy are already known and identified.
Under the proposed regulations, both healthcare professionals and patients would receive in their reports and lay summary letters more detailed identifying information about the mammography facility to aid in post-exam communications, the agency said.
The proposed rule will be open for public comment for 90 days after publication.
Read the FDA press release.
View the proposed rule.
Posted 3/27/2019
