Must mammography units that are used exclusively for stereotactic breast biopsy be certified under MQSA?
A. No, not at this time. Although these procedures do involve radiography of the breast, stereotactic breast biopsy is currently exempt from MQSA regulations; however, any mammography unit or personnel involved, even occasionally, in routine screening or diagnostic mammograms must meet MQSA quality standards. These units must be included in the accreditation process and will be covered under the MQSA certificate. See the FDA Policy Guidance Help System for more information.
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