Federal performance standard for diagnostic x-ray systems and their major components--FDA. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to amend the Federal performance standard for diagnostic x-ray systems and their major components (the performance standard). The amendments revise the limits established for maximum patient entrance exposure rates for fluoroscopic x-ray systems during high-level control and other modes of operation. The revisions are being made due to concerns regarding excessively large radiation exposure rates on some fluoroscopic x-ray systems. In addition, an inadvertent error is being corrected to improve the accuracy of the regulations.