FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
Information
for mammography facility personnel, inspectors, and consumers about the implementation of the Mammography Quality Standards Act of 1992 (MQSA) |
What are the Key Features of MQSA?
To operate lawfully, a mammography facility must be MQSA certified as providing quality mammography services.
For a facility to be certified, it must be accredited by a federally approved private nonprofit or state accreditation body. FDA has approved the American College of Radiology (ACR) and the States of Arkansas, California, Iowa, and Texas as accreditation bodies. If additional States become approved, FDA will make the appropriate announcement.
To be accredited, the facility must apply to an FDA-approved accreditation body; undergo periodic review of its clinical images; have an annual survey by a medical physicist; and meet federally developed quality standards for personnel qualifications, equipment, radiation dose, quality assurance programs, and recordkeeping and reporting.
The facility must also undergo an annual inspection conducted by federally trained and certified Federal or State personnel. Inspections began in January 1995. See MQSA Regulations and Guidance for more information.
Who Must Meet MQSA Requirements?
All mammography facilities that produce, process, or interpret mammograms. (Exceptions are facilities that are under the Department of Veterans Affairs, which has developed its own mammography quality program similar to MQSA.) Requirements cover personnel, equipment, radiation dose, quality assurance programs, and recordkeeping and reporting.
Accreditation bodies (State or private nonprofit organizations).
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home PageCenter for Devices and Radiological Health / CDRH