2020 Governmental Entity Audit
On August 17, 2020, the U.S. Food and Drug Administration (FDA) will begin its Governmental Entity (GE) audit of certified mammography facilities who claim this exemption under the Mammography Quality Standards Act (MQSA). The MQSA requires that mammography facilities submit an annual self-certification form (Form FDA 3422) to have the annual mammography inspection fee waived.
To verify these claims, the FDA has randomly selected a sample of 90 mammography facilities currently claiming GE status, between the dates of October 1, 2018 through December 31, 2019, to participate in this audit. The FDA will contact these facilities to advise them of the steps they need to take to verify their GE exemption status.