|
 
Today, the U.S. Food and Drug Administration (FDA) issued this final rule: Mammography Quality Standards Act (MQSA). The final rule includes updated requirements that will modernize breast cancer screening and help empower patients by providing more information when they consider their breast health care.
Facts about the final rule
This final rule makes improvements to three categories of the existing mammography regulations based on current science and mammography best practices, including:
- Taking into account changes in mammography technology
- Enhancing the FDA’s ability to enforce quality standards
- Changing the way mammography results are categorized, reported, retained, and transferred to patients and health care providers to help them make more informed health care decisions.
The requirements in this final rule are to be implemented within 18 months following publication in the Federal Register. On the effective date of the final rule, the FDA intends to make a number of updates to other documents to reflect these changes to the mammography regulations, including the publication of a Small Entity Compliance Guide.
Questions?
If you have questions about this final rule, MQSA Facility Hotline by telephone at 800-838-7715 or by email at MQSAhotline@versatechinc.com.
|
|
|
|
