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| What's New                                                                                                 |
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| About MQSA                                                                                                 |
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| HHS Home                                                                                                   |
| PDF means the file is in Adobe Portable Document Format.  Download AdobePDF Reader if you can't view PDFs. |

| MQSA guidance interprets MQSA regulations and addresses compliance issues.  It is meant to help facilities comply with MQSA regulations, but it does not have the force of law.  If facilities follow the guidance developed for a specific MQSA requirement, they will be considered to have met the requirement.  However, as guidance is intended to *guide*, not *mandate,* facilities may identify other ways of meeting MQSA requirements.
In contrast, the MQSA final regulations are national quality standards for mammography services.  Written by FDA, these regulations are based on MQSA of 1992 and MQSA Reauthorization of 1998.  They have the force of law.  Words such as "shall," "must," and "require" are used when stating statutory or regulatory requirements.

Draft and Approved Guidance

Guidance issued by FDA follows the Good Guidance Practices protocol.  FDA receives questions from the mammography community, develops and publishes proposed guidance, receives and evaluates comments from the public, and finalizes the guidance.    

Draft guidance, on which the public is encouraged to comment, is initially published on this website; Draft guidance documents appear below.Approved guidance is also published on this website and incorporated into the Policy Guidance Help System. Guidance in the Policy Guidance Help System represents FDA's current thinking on the MQSA final regulations.  

Policy Guidance Help System 

**The Policy Guidance Help System was last updated on July 14, 2000.**

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.

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, and NT users only).

You may download the PGHS to run on your own system.  To do so, click ondownload the Policy Guidance Help System, select the "Save this program to disk" option to download the self-extracting file, GUIDANCE.EXE (579kb), toyour computer.  Then double-click on GUIDANCE.EXE and follow the instructions to complete the installation of the help system.

**The Policy Guidance Help System was last updated on July 14, 2000.** Check this website on a regular schedule to make sure that you have downloaded and installed the most recent version of the PGHS.

If you have trouble downloading the Policy Guidance Help System, refer to installation tips.

**Draft Guidance**
- Compliance Guidance (Draft): The Mammography Quality Standards Act Final Regulations: Document #4 (issued 9/13/2000)     [Text]  [PDF]
The public may submit comments and suggestions on the proposed guidance throughout the 90-day comment period. 

**Teleconference**

Information about CME/CEU credit for viewing the February 18, 1999, Teleconference.

**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, as well as other items such as the *Mammography Matters* newsletter.  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 are usually sent after normal business hours. |
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