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The first is that the FDA will levy a fine for the first violation of the new regulations. That fine is to be at least $1.5 million or up to $15 million, whichever is greater. The FDA has published a list of medical imaging items that are the targets for the regulations. The list includes computed tomography (CT) scans of the head, chest, abdomen and pelvis; CT colonography (a test in which the colon is x-rayed to detect colon polyps that can be removed) and magnetic resonance imaging* (MRIs). The item not on the list is a lab test for bone density.


The fourth milestone is that two months after the law takes effect, the FDA will publish any revisions of the new regulations as necessary. The FDA currently plans on updating the list of items subject to the new regulations no more than once a year. The list will be revised, if necessary, to conform to changes in technology, FDA information and new safety data.


MITA and the American College of Radiology announced yesterday that they and the Digital Imaging and Communications in Medicine* (DICOM) industry are developing a voluntary "research instrument" whose primary purpose is to develop software to estimate radiation exposure during CT scans. DICOM is the industry standard for medical imaging and anything other than DICOM is non-standard. CT scans are almost always done in non-industrially derived DICOM devices, or if they are used in a commercial CT scanner, the data is exported for use with non-industrially derived DICOM devices.


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