FDA to stop mailing Mammography Quality Standards Act materials

The U.S. Food and Drug Administration on Thursday announced it will soon stop mailing Mammography Quality Standards Act certificates and other related materials, necessitating action from breast imaging providers. 

Beginning on Oct. 22, the agency will instead be delivering these credentials through a new online system called the MQSA Facility Portal. With the change, imaging providers will be responsible for downloading their FDA-issued certificates for display. 

The agency is offering a transition period beginning Sept. 14, giving a little over a month to comply. During this time, centers may receive both a physical certificate and an electronic message with instructions on how to retrieve the web version. 

“When a facility receives an email from the MQSA Facility Portal, which contains a certificate update, it will be the responsibility of each facility to download, print and display the MQSA certificate,” the FDA emphasized in an update published Sept. 10. 

Meanwhile, for facilities governed by an FDA-approved State Certifying Agency—including Illinois, Iowa, South Carolina and Texas—the new process will not apply. Others will receive three-year certificates, issued when they complete their accreditation process. Portal notification emails will include step-by-step instructions explaining how to access the system and download documents. 

If any information needs to be updated or verified, facilities are encouraged to contact the CDRH MPRIS Helpdesk at [email protected].

Subscribe to Radiology Business News

Radiology Business Marty Stempniak

Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic. 

Subscribe to Radiology Business News

Subscribe to Radiology Business News