Draft Guidance for Industry and Food and Drug Administration Staff; the Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System 13." This document is intended to provide guidance to mammography facilities and their personnel. It represents FDA's current thinking on the final regulations implementing the Mammography Quality Standards Act of 1992 (MQSA). This guidance document updates previous guidance. This draft guidance is not final nor is it in effect at this time.