FDA to amend MQSA rules for x-ray

September 30, 1998

X-ray equipment designed for various applications may be used for mammography, according to a new draft compliance document of the Mammography Quality Standards Act (MQSA) issued by the Food and Drug Administration on Aug. 27. The document states that

X-ray equipment designed for various applications may be used for mammography, according to a new draft compliance document of the Mammography Quality Standards Act (MQSA) issued by the Food and Drug Administration on Aug. 27. The document states that mammography procedures may be performed on general x-ray devices, provided that the devices meet all applicable MQSA requirements and have been “optimized for mammography.”

Final MQSA rules were published in October 1997 and amended a month later. The August guidance clarifies the final guidance’s section 21 CFR 900.12, which prohibits the use of general-purpose equipment for mammography imaging, requiring that x-ray equipment be specifically designed for mammography uses. The FDA will accept written comment on the draft guidance until Nov. 25.

When final, the draft compliance document may have beneficial effects for companies such as Fuji, which has had to hold back from market a mammography module for its general-purpose computed radiography systems. Fuji’s system had originally been cleared for mammography applications, but when the FDA began to review digital mammography guidance with greater scrutiny, it asked the company to remove that capability from the system, according to Fuji executives. When the MQSA guidance becomes final in April 1999, commercializing general x-ray systems for mammography uses may get easier.