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for mammography facility personnel, inspectors, and consumers about the implementation of the Mammography Quality Standards Act of 1992 (MQSA) |
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Draft and Final Guidance
Policy Guidance Help System
Other Guidance
FDA follows its Good Guidance Practice’s protocol when issuing guidance. Guidance is developed in response to questions we receive from the mammography community, patients and other interested parties. FDA issues guidance as either draft or final. Draft guidance is issued when the matter being addressed is new, complicated or controversial. Draft guidance is published for public comment and is issued as final only after the public’s comments are considered. Guidance is issued as final if it not new, complicated or controversial or has already gone through the draft process.
Draft guidance documents that currently are open for public comment may be accessed by clicking on Draft Guidance. Final guidance documents may be accessed by clicking on Final Guidance. Final Guidance is also incorporated into the Policy Guidance Help System. Guidance in the Policy Guidance Help System represents FDA's current thinking on the MQSA final regulations.
The Policy Guidance Help System was last updated on October 23, 2003.
The Policy Guidance Help System (PGHS) is an information resource that is structured like a Windows help system. It is organized by main topics, or books. Each book includes a list of subtopics, or pages, that contain guidance. Many of the pages begin with the regulatory citation related to the selected topic, followed by questions and answers offering guidance on how to comply with the regulations.
You can view the PGHS live (on the website) and/or download it to run on your own computer. To view or use the website version, your browser must be Java enabled.
In the latest version of the web-based PGHS, the "Search" function has been replaced by a "Search" index. If you wish to continue using the original PGHS "Search" function, please use the downloadable version of the PGHS.
If you have trouble using the website version of the PGHS, refer to the troubleshooting tips.
Installing the Policy Guidance Help System on Your Own Computer (for Windows 95, 98, ME, 2000, XP, NT and UNIX users only).
You may download the PGHS to run on your own system. To do so, click on download the Policy Guidance Help System, select the "Save this program to disk" option to download the self-extracting file, GUIDANCE.EXE (605kb), to your computer. Then double-click on GUIDANCE.EXE and follow the instructions to complete the installation of the help system.
Check this website on a regular schedule to make sure that you have the most recent version of the PGHS installed on your computer. You can also receive e-mail notification of any updates by subscribing to our ListServ.
If you have trouble downloading the Policy Guidance Help System, refer to installation tips.
CDRH Facts-On-Demand
CDRH Facts-On-Demand (F-O-D) is an automated fax-back system that faxes requested documents. Both final and draft guidance documents are available. Identify the number of the document you want from the index and follow the instructions at the top of the F-O-D index page. Note that long documents may be faxed after normal business hours or may be mailed.
Updated October 31, 2003
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