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January 14, 1974

FDA Standards for Diagnostic X-ray Equipment

Author Affiliations

H. G. Fischer, Inc. Franklin Park, Ill

JAMA. 1974;227(2):203. doi:10.1001/jama.1974.03230150051025

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To the Editor.—  A recent news release from the Food and Drug Administration concerned performance standard for diagnostic x-ray equipment that becomes effective Aug 1, 1974.As a manufacturer that provides diagnostic x-ray equipment to the medical profession, we would like to comment on this law, since so many practitioners have asked us for clarification.The performance standard was promulgated by the Bureau of Radiological Health as required by the Radiation Control for Health and Safety Act of 1968. The performance standard will apply to x-ray equipment manufactured after Aug 1, 1974, and will not affect equipment currently in use or equipment that is installed prior to Aug 1, 1974.The primary intent of the law is to reduce unnecessary radiation caused by retakes and improper beam collimation. As such, automatic collimation will be mandatory on all equipment sold after Aug 1, 1974. In addition, manufacturers must certify that the