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

Riepilogo

The Food and Drug Administration (FDA) is announcing the increased fees the agency will assess for inspections of mammography facilities starting October 1, 2007. 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, FDA is raising the fees to ensure the program is able to meet its objective of ensuring that high quality mammography remains available to women. 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.