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 In this section:

                Facility Certification and Inspection (MQSA)

Facility Certification and Inspection (MQSA)

                        Mammography Safety Notifications
          Inspection News
          Digital Accreditation
          Facilities - Mammography Quality Standards Act Requirements
          Facility Certification and Inspection Mammography Quality Standards Act (MQSA): Inspection Fees
          MQSA:  Accreditation Bodies
          Residency Letter for Residency Graduates of 2014 or Later
          Facility Certification and Inspection: CMS Reimbursement Issues
          Inspection Procedures
          Preparing for an Inspection
          Revised MQSA Policy on Follow Up for Inspection Violations Home
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          Facility Certification and Inspection (MQSA)
          Mammography Safety NotificationsFacility Certification and Inspection (MQSA) Mammography Safety Notifications
  
  	
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    PrintUnder the Mammography Quality Standards Act (MQSA) of 1992, the FDA requires that all mammography facilities meet certain high quality standards. When a facility fails to meet the standards, the FDA requires it to notify affected patients and their referring health care providers that their recent mammograms could have unreliable results.

In the cases where a facility cannot or will not demonstrate to FDA's satisfaction that all affected patients were successfully notified, the FDA posts Mammography Safety Notifications to this website.

Safety Notifications

Title
			DateUpdated: Mammography Problems at Advanced Women Imaging in Guttenberg, NJ: FDA Safety Communication
			02/07/2023Mammography Problems at Madison Avenue Radiology Center 190th Broadway in New York, New York: FDA Safety Communication
			08/26/2021UPDATE: Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication
			06/30/2022Mammography Problems at Tennessee Women’s Care P.C. in Nashville, TN: FDA Safety Communication
			03/30/2021Mammography Problems at Allison Breast Center at Monument Radiology in Richmond, Virginia: FDA Safety Communication [ARCHIVED]
			09/25/2020Mammography Problems at East Palestine Family Medical Clinic in East Palestine, Ohio: FDA Safety Communication [ARCHIVED]
			04/26/2019Mammography Problems at Aims Diagnostic Imaging in Manahawkin, NJ: FDA Safety Communication [ARCHIVED]
			09/24/2018Problem with Quality of Mammograms at Palm Beach Broward Medical Imaging Center in Deerfield Beach, Florida: FDA Safety Communication [ARCHIVED]
			01/03/2018Problem with Quality of Mammograms at Boston Diagnostic Imaging in Orlando, Florida: FDA Safety Communication [ARCHIVED]
			08/17/2015Problem with Quality of Mammograms at Coastal Diagnostic Center in Pismo Beach, California: FDA Safety Communication [ARCHIVED]
			04/30/2015Problem with Quality of Mammograms at J. Bruce Jacobs M.D., Inc., doing business as Huntington Radiology in Huntington Park, California: FDA Safety Notification [ARCHIVED]
			04/13/2015Problems with Quality of Mammograms at Richard D. Adelman M.D. in Raleigh, North Carolina: FDA Safety Communication [ARCHIVED]
			03/24/2015Mammography Problems at Big Sky Diagnostic Imaging, LLC in Butte, Montana: FDA Safety Communication [ARCHIVED]
			06/23/2014Mammography Problems at San Sebastian X-Ray in San Sebastian, Puerto Rico: FDA Safety Communication [ARCHIVED]
			06/27/2013Medisound, Inc./Digital Radiology Center, in Kissimmee, Florida Performing Mammography Without an MQSA Certificate: FDA Safety Communication [ARCHIVED]
			09/28/2012Mammography Problems at Huntington Radiology in Huntington Park, California [ARCHIVED]
			03/10/2011

                                                                                  Content current as of:
      02/07/2023
              
              
Regulated Product(s)
		 Medical Devices
			  			     			  			     Radiation-Emitting ProductsFacility Certification and Inspection (MQSA)

          
                        Mammography Safety Notifications
          Inspection News
          Digital Accreditation
          Facilities - Mammography Quality Standards Act Requirements
          Facility Certification and Inspection Mammography Quality Standards Act (MQSA): Inspection Fees
          MQSA:  Accreditation Bodies
          Residency Letter for Residency Graduates of 2014 or Later
          Facility Certification and Inspection: CMS Reimbursement Issues
          Inspection Procedures
          Preparing for an Inspection
          Revised MQSA Policy on Follow Up for Inspection Violations
 
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