FDA proposes changes to mammography regulations
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FDA proposes changes to mammography regulations

by Thomas Dworetzky, Contributing Reporter | March 27, 2019
Women's Health
New proposed mammogram policy changes focusing on the treatment of women with dense breast tissue and facility compliance with standards were announced today by the U.S. Food and Drug Administration.

The changes are the first to “modernize” breast screening in over two decades.

“As part of our overall commitment to protecting the health of women, we’re proposing new policies to modernize our oversight of mammography services, by capitalizing on a number of important advances in mammography, like the increased use of 3-D digital screening tools and the need for more uniform breast density reporting,” said FDA Commissioner Dr. Scott Gottlieb in a statement.

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The proposal would amend the Mammography Quality Standards Act of 1992 (MQSA), which authorizes agency oversight over mammography facilities, and would “better position FDA to enforce the MQSA regulations and take action when violations are found,” according to the agency.

The proposed changes would add information about breast density to the letter given patients and reports sent to referring medical professionals. Specifically, three additional categories would be added to assessment codification – including one called “known biopsy proven malignancy,” as well as including detail about the facility as an aid to follow-up conversations.

Dense breasts, which are a cancer risk factor, can also make mammograms tougher to read.

The proposed changes include, the FDA noted:

-Expressly stating that the FDA can directly notify patients and their health care professionals, should facilities be unwilling or unable to do so, that mammography at a facility did not meet quality standards and that reevaluation or repeat of the mammogram at another certified facility may be needed;

-Requiring that only digital accessory components specifically FDA approved or cleared for mammography be used, or that facilities use components that otherwise meet the requirements under the rule;

-Strengthening record-keeping requirements to minimize information loss and improve access to and transfer of patient mammography records.

“Once finalized, these proposed amendments will enhance our oversight of mammography facilities, including in the key area of enforcement and patient communication,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, explaining that, “while the majority of certified mammography facilities are dedicated to providing high levels of patient care, today’s proposed regulations would enhance the FDA’s ability to communicate directly, if needed, with patients and their health care professionals in cases where facilities did not meet our quality standards and are not adequately communicating with patients about their facilities’ deficiencies.”

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