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

Regulations (MQSA)

                        
                Alternative Standards (MQSA)
          Mammography Quality Standards Act (MQSA)
          Mammography Quality Standards Act Regulations Home
          Radiation-Emitting Products
          Mammography Quality Standards Act and Program
          Regulations (MQSA)Mammography Quality Standards Act and Program Regulations (MQSA)
  	
        Share
    Post
    Linkedin

    Email
    PrintOn March 10, 2023, the FDA issued the Final Rule to Amend the MQSA Regulations. These updated requirements are to be implemented within 18 months after publication in the *Federal Register*. As noted in the final rule, the FDA concluded that 18 months was a practical timeframe for facilities to implement these requirements without undue hardship. Facilities are not precluded from including the required breast density notification prior to 18 months; however, facilities subject to MQSA must comply with all the requirements, including the breast density notification, no later than September 10, 2024. The information on this webpage will be updated further when the amended MQSA regulations go into effect.


About Regulations

MQSA guidance interprets MQSA regulations and addresses compliance issues. It is meant to help facilities comply with MQSA Final 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.

Related Links

MAMMOGRAPHY QUALITY STANDARDS ACT (MQSA)
	Important Information: Final Rule to Amend the Mammography Quality Standards Act (MQSA)

                                                                                  Content current as of:
      01/12/2024
                  
                   
Regulated Product(s)
		 Radiation-Emitting ProductsRegulations (MQSA)                
                          

                        Alternative Standards (MQSA)
          Mammography Quality Standards Act (MQSA)
          Mammography Quality Standards Act Regulations
 
 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