This manual was last updated December 3, 2007.
We recommend that you download the Policy Guidance Help System to run on your own computer. However, it is important to remember that the guidance is updated on a regular basis, so you should check FDA's Mammography website to make sure that you have the most current information. Individuals wishing to get automatic notification of such updates may subscribe to our E-mail Listserv by visiting GovDelivery and following the directions there.
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance by sending your inquiry to: MQSAhotline@hcmsllc.com.
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 books or main topics (see the Contents tab to the left). To view the list of topic titles in a specific book click on the "+" symbol or double-click on the book icon. To see the contents of a topic, simply click on its title.
The Index consists of a list of keywords associated with appropriate topics. Click on the Index tab on the left side of this screen to display the list of keywords. You may scroll through all the keywords or type in a keyword in the box at the top of this list. To see topics associated with a specific keyword, click on it and the relevant topics will appear in a box. To go to one of these topics, click on its topic title.
To print the text in the right window pane, just highlight a word in that pane and print as usual.
To search for any word in the system, click on the Search tab. Follow the "Find Setup Wizard" instructions to generate the list of words. Once the word list has been generated, follow the keyword procedures.
All pages have a "non-scrolling" area at the top of the page. This area may contain references to sections within the topics, such as "Questions" or "Key Words/Related Topics." These references are hyperlinked – that is, you can click on them to quickly go to that section. Because this area does not scroll, it allows you to easily navigate within topics.
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. Clicking on a Keyword will bring up a pop-up box from which you can choose to see another topic by clicking on it. If there is only one topic for the key word, you will go directly to that topic. Clicking on a Related Topic will take you directly to the related topic.
If you want to make the font size on the screen larger or smaller, choose "Options" from the top menu, then "Font," then highlight the desired font size.
If you have comments or questions about the Policy Guidance Help System, please submit them via e-mail to MQSAhotline@hcmsllc.com.
Version 9.1