Policy Guidance Help System

The Policy Guidance Help System was last updated December 1, 2010 

Welcome to the Policy Guidance Help System (PGHS).

The Policy Guidance Help System (PGHS) is intended to provide useful information to mammography facilities and their personnel. It represents the Food and Drug Administration’s (FDA) current thinking on the final regulations implementing the Mammography Quality Standards Act (MQSA) (Pub. L.102-539). The FDA uses mandatory language, such as shall, must, and require, when referring to statutory or regulatory requirements. The FDA uses non-mandatory language, such as should, may, can, and recommend when referring to guidance. It is the responsibility of the facility to read, understand, and follow the final regulations.

Under its own authority, a State may impose more stringent requirements beyond those specified under MQSA and its implementing regulations. A facility may want to check with its State or local authorities regarding their requirements.

The system is organized as a series of main topics (Table of Contents). To see the contents of a topic, simply click on its title.

The Key Word Listing consists of a list of keywords associated with appropriate topics. To see topics associated with a specific keyword, click on it and the relevant topics will appear.

Many of the pages begin with the regulatory citation related to the selected topic, followed by a discussion and/or a series of questions and answers offering guidance about how FDA implements the regulations.

The topics conclude with a list of key words and related topics. 

If you have comments or questions about the Policy Guidance Help System, please submit them via e-mail to MQSAhotline@hcmsllc.com.