Stereotactic breast biopsy now included in MQSA regulations

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The National Mammography Quality Assurance Advisory Committee advised the FDA to lift the current exemption of stereotactic breast biopsy from the Mammography Quality Standards Act (MQSA) regulations at a hearing held Nov. 5 in Rockville, Md.

The committee voted (9-5) in favor of regulating stereotactic breast biopsy facilities, citing current variable quality, lack of voluntary participation in existing accreditation programs and dose concerns, according to the FDA. Those voting against the proposal cited access issues, no scientifically documented need, and that MQSA did not intend to address interventional procedures.

The panel openly discussed their views and heard testimony from the ACR, the Society of Breast Imaging, the American College of Surgeons, the American Society of Breast Surgeons, the Medical Imaging and Technology Alliance, radiologists and consumer advocates before casting their vote.

All speakers and committee members agreed that regulations should not be written to effectively exclude any specialties. The FDA said they will take this advice under consideration as they draft revisions to their mammography regulations.