Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        Mammography Quality Standards Act and Program

Guidance (MQSA)

                        
                


                Policy Guidance Help System Home
          Radiation-Emitting Products
          Mammography Quality Standards Act and Program
          Guidance (MQSA)Mammography Quality Standards Act and Program Guidance (MQSA)
  	
        Share
    Post
    Linkedin

    Email
    PrintNew Format for the PGHS

Due to changes in the Food and Drug Administration web site, the MQSA Program has been asked to re-format the Program's widely-used Policy Guidance Help System (PGHS). Since its inception in the 1990's, the PGHS has been the repository of all guidance issued by the Division of Mammography Quality Standards, consolidated in one place for easy reference by the entire mammography community and consumers.

The PGHS in its new format will be made available on the FDA's MQSA web site. The new format has advantages over the current, web-based format: it has an index, it's searchable, and it has a glossary. Also, the entire PGHS can be downloaded in an easy-to-use Compiled HTML Help File format; this Help File version is small in size, so it can be easily downloaded over the slowest Internet connection. However, you must have WinZip or equivalent software to decompress the downloaded file.

We have corrected some transcription errors which were pointed out to us by users of the PGHS; however, the policy content is unchanged.

Draft and Approved 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.

Drafts of proposed guidance currently open for public comment will be provided in the section below. 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.

Other Guidance Documents

Documents that provide additional assistance in complying with MQSA requirements include:

Mammography Equipment Evaluation (MEE) Scope for Newly Installed FFDM  Systems
	Notification Protocols When a Facility Moves a Mammography Unit
	Laser Printer Test Procedures in the Current FFDM  Manufacturer QC Manuals
	Communicating Mammography Results to Women
	Electronic Product Radiation Control Program: Industry Guidance

                                                                                  Content current as of:
      08/14/2018
                  
                   
Regulated Product(s)
		 Radiation-Emitting ProductsGuidance (MQSA)                
                          

                        


                        Policy Guidance Help System
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop