Medical Devices: Mammography Quality Standards Act of 1992 and Subsequent Mammography Quality Standards Reauthorization Act and Amendments; Inspection Fees

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The Food and Drug Administration (FDA) is announcing the new fees the agency will assess for inspections of mammography facilities starting October 1, 2003. The Mammography Quality Standards Act of 1992 (the MQSA) requires FDA to assess and collect fees from mammography facilities to cover the costs of annual inspections required by the MQSA. Because these costs have increased since the last increase on February 13, 1998, FDA is raising the fees accordingly. This document explains which facilities are subject to payment of inspection fees, provides information on the costs included in developing inspection fees, and provides information on the inspection billing and collection processes. This is only the second increase in inspection fees under the MQSA since the initial fee was established in 1995.