HHS Issues Alert on Info Blocking Enforcement
HHS issued an enforcement alert that info blocking rules still apply. ACR has radiology-focused guidance and FAQs available.
Read moreMain Content
FDA Releases Final Guidance For MQSA Regulation Changes Effective Sept. 10
Aug. 29, 2024
The U.S. Food and Drug Administration (FDA) this week provided notice of final guidance issued by the Center for Devices and Radiological Health, Mammography Quality Standards Act (MQSA) and Regulation Amendments: Small Entity Compliance Guide (SECG). The FDA developed the SECG to explain the actions a small entity must take to comply with the MQSA rule and its implementing regulations.
The March 2023 MQSA rule modernized mammography regulations and specifies that the mammography report given to patients specifies if they have dense or non-dense breast tissue; it includes a prescribed paragraph on the significance of breast density.
The FDA prepared the SECG to help small entities comply with MQSA regulation changes, which take effect Sept. 10.
For more information, contact Katie Grady, American College of Radiology® Government Affairs Director.
The March 2023 MQSA rule modernized mammography regulations and specifies that the mammography report given to patients specifies if they have dense or non-dense breast tissue; it includes a prescribed paragraph on the significance of breast density.
The FDA prepared the SECG to help small entities comply with MQSA regulation changes, which take effect Sept. 10.
For more information, contact Katie Grady, American College of Radiology® Government Affairs Director.
Related ACR News
MedPAC Meeting Highlights Medicare Policy
The MedPAC meeting included discussions about improving payment accuracy and the Medicare program’s overall financial situation.
Read moreReport Backs NIH Changes to Reduce Childhood Chronic Diseases
The report includes a recommendation that NIH launch a chronic disease initiative using a whole-person approach to research chronic disease prevention.
Read more