Labor and Economic Opportunity
Since the quality of mammograms is one of the most important determinants of the accuracy of mammography, the production of high quality clinical images by certified mammography facilities is one of the primary goals of the Mammography Quality Standards Act (MQSA). In fact, there are MQSA regulations which specifically address clinical image quality. Inspection questions related to these clinical image quality regulations have previously not been part of the annual inspection. As part of its Enhancing Quality Using the Inspection Process (EQUIP) initiative, FDA’s Division of Mammography Quality Standards (DMQS) developed inspection questions related to the image quality regulations and added them to the inspection program, thereby emphasizing the significance of continuous clinical image quality.
Attached is a document which combines all the current information and resources DMQS has posted on the MQSA Website for the EQUIP initiative to include the following:
The bold underlined text in this document are hyperlinks for web addresses. You can simply click on them to access the website information. If you have been given a hardcopy of this document or you are having trouble accessing the hyperlinks, you can also go to www.fda.gov/mammography and click on "EQUIP Program Information" under the "What's New" section to view these documents.
Any questions regarding the EQUIP initiative may be answered by your MQSA inspector, or facilities may contact the MQSA Facility Hotline at 800-838-7715 or by e-mail at MQSAhotline@versatechinc.com.