Guidance for Industry and FDA Staff on the Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #6; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System [numsign]6." This document deals with testing of a mammography unit's Automatic Exposure Control (AEC) component and is intended to provide guidance to mammography facilities and their personnel. It represents FDA's current thinking on this aspect of the final regulations implementing the Mammography Quality Standards Act.