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 on the Federal performance standard for diagnostic X-ray systems and their major components (the performance standard). Experience gained by FDA in administering the performance standard has shown the need for making these changes to clarify and simplify the performance standard, reduce the regulatory burden on affected manufacturers (without compromising the public health), and generally improve the effectiveness of FDA's regulation of diagnostic X-ray equipment. Elsewhere in this issue of the Federal Register, FDA is proposing to amend this final rule to revise limits on the maximum patient entrance exposure rate for fluoroscopy systems in the high-level control mode and other modes of operation.