The U.S. Food and Drug Administration (FDA) has issued a draft guidance for an update to its radiation control regulations covering the manufacturing of diagnostic x-ray equipment. The guidance will supersede previous rules issued in 1989.
Titled "Clarification of radiation control regulations for manufacturers of diagnostic x-ray equipment," the document outlines the agency's thinking on a variety of issues with respect to radiation-emitting devices, from warning labels to handling accidental radiation events. The document is set in a question-and-answer format to provide guidance to equipment manufacturers.
The FDA noted, however, that guidance documents "do not establish legally enforceable responsibilities," unless specific regulatory or statutory requirements are cited. The FDA is taking comments on the guidance through February 19, 2019.
