The National Mammography Quality Assurance Advisory Committee (NMQAAC) advised the U.S. Food and Drug Administration (FDA) to lift the current exemption of stereotactic breast biopsy from the MQSA regulations at a meeting held Nov. 5 in Rockville, Md.

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.

D. David Dershaw, M.D., of the ACR Breast Imaging Government Relations Committee, and Carol H. Lee, M.D., president of the SBI and chair of the ACR Breast Imaging Commission, urged the FDA to include stereotactic breast biopsy under the MQSA regulations, so they will apply to all physicians performing the procedure and quality can be ensured for all women.

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 on the hearing, go to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=685

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