126 - Late Breaking Changes to MQSA Regulations

Do you work in the breast imaging industry of healthcare? Have you ever wondered what standards your mammogram providers are held to? Are you curious how you can learn more about FDA regulations for these procedures?

Welcome to Mammologix Mini Moments, powered by DoctrinaEdge Publishing! These bite-size info videos will explain the important roles, responsibilities, and factors that contribute to the high-quality standards breast imaging facilities uphold to retain FDA certifications.

Thank you for joining us—we’re excited to share our knowledge with you!

For more info, check out our MQSA Changes Quick Reference Guide on Issuu here: https://issuu.com/ezphotoscan/docs/mqsa_updates_quick_reference_guide?fr=sMTc3ZjY0NjE3MzA

And take a look at our Knowledge Hub for even more information: http://mammologix.fyi/home

Video Sources:

Center for Devices and Radiological Health. (n.d.). MQSA Alternative Standard #12. FDA. https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mqsa-alternative-standard-12-assessment-category-post-procedure-mammograms-marker-placement

Center for Devices and Radiological Health. (n.d.). MQSA Alternative Standard #11. FDA. https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mqsa-alternative-standard-11-modifications-assessment-categories-used-medical-reports

Center for Devices and Radiological Health. (n.d.). MQSA Alternative Standard #8. FDA. https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mqsa-alternative-standard-8-separate-assessment-findings-each-breast

Food and Drug Administration. (n.d.). Withdrawal of Approval and Amending of Mammography Quality Standards Act Alternative Standards. Federal Register. https://www.federalregister.gov/documents/2024/08/26/2024-19058/withdrawal-of-approval-and-amending-of-mammography-quality-standards-act-alternative-standards