Advisory Committee Votes to Include Stereotactic Breast Biopsy under MQSA Regulations

November 9, 2007 - The National Mammography Quality Assurance Advisory Committee advised that the FDA lift the current exemption of stereotactic breast biopsy from the MQSA regulations at a meeting held Nov. 5.

Nine out of 14 members of the committee voted in favor of regulating stereotactic breast biopsy facilities, citing current variable quality, lack of voluntary participation in existing accreditation programs, and dose concerns. Those voting against the proposal cited access issues, no scientifically documented need, and that MQSA did not intend to address interventional procedures.

After testimony from the ACR, the Society of Breast Imaging (SBI), the American College of Surgeons, the American Society of Breast Surgeons, the Medical Imaging and Technology Alliance, radiologists and consumer advocates, the panel openly discussed their views before voting.

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

For more information: www.fda.gov