FDA readies new MQSA audits

The U.S. Food and Drug Administration (FDA) said that on June 23 it will begin an audit of certified mammography facilities that claim a Government Entity (GE) exemption under the Mammography Quality Standards Act (MQSA).

MQSA requires that mammography facilities submit an annual self-certification form to have the annual mammography inspection fee waived. To verify these claims, the FDA will audit a randomly selected sample of 100 mammography facilities currently claiming GE status from dates ranging between October 1, 2012, and December 31, 2013.

The FDA said it will contact these facilities to advise them of the steps they need to take to verify their GE exemption status.