FDA Policy Guidance

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Introduction

This manual was last updated July 14, 2000.

It is recommended 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.

Welcome to the Policy Guidance Help System!

The guidance presented here reflects FDA’s current thinking on the final regulations implementing the Mammography Quality Standards Act (MQSA) (Pub. L.102-539).

The system is organized as a series of books or main topics. To see the pages, or sub-topics, contained in a book, double-click on the book. A list of pages will appear. To see the contents of a page, simply double-click on the page. Click the Index tab to search for any word or topic contained in this manual. To find a word contained in any subject, click the Search tab and type in the word. A list containing all of the topics found containing the word will appear. Click the topic to see it.

For each topic, there may be references below the topic title that define specific sections within that topic, 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 of the topic. Use the scroll bar to go back to the top of the topic.

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 will implement the regulations.

The topics conclude with a list of key words and related topics. Clicking on a key word 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 E-Mail dmqrp@....