Remember the beginning of HCFA inspections in the early 1990's?  When regulations were new and inspections were unannounced and frightening?

Inspection of mammography facilities has come a long way since the implementation of the Mammography Quality Standards Act of 1992 (MQSA).  When the FDA added a 5 day notice to facilities of their upcoming inspection and regulations became more familiar, the stress and anxiety of  inspections was lessened somewhat.  The goal of MQSA is to assure that mammography is safe and reliable and breast cancer is detected in its earliest stages when it is most treatable. Since the implementation of MQSA Regulations, image quality has improved immensely.

The state of North Carolina, through a contract with the FDA, supplies inspectors to inspect North Carolina Mammography facilities to insure compliance with MQSA.  These inspectors are trained and certified by the FDA.  We have a staff of 4 inspectors.  If you have any questions regarding an inspection or the MQSA Regulations, our inspectors  are excellent resources.

The Final MQSA Regulations went into effect April 28, 1999.

A copy of the final MQSA Regulations can be found on the FDA website. Numerous other publications can also be found on the FDA website that offer more information regarding interpretation of the Final Regulations.  The most valuable tool is the Policy Guidance Help System.  Since April 28, 1999, our inspectors have conducted their inspections following the Final Regulations.  These Final Regulations will further assist our state and the FDA in achieving our ultimate goal of safe mammography and early detection of breast cancer.

NOTICE:  The FDA uses their entire website to bring you key mammography news as it emerges.  Additions to the Policy Guidance Help System is an ever changing process.  You may sign up to receive automatic notification of updates when they are added to the website.  

Click here to sign up to the electronic listserv to receive e-mail alerts and highlights of the FDA website as they become available.
 

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