Medical Devices: Draft Guidance for Industry and FDA; The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #6; Availability

Samenvatting

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System [numsign]6; Draft Guidance for Industry and FDA." The draft guidance document is intended to assist facilities and their personnel in meeting the MQSA final regulations. This document deals with requirements related to testing of the automatic exposure control (AEC) component of mammography units.