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FDA SEEKS COMMENTS ON UPDATE RADIATION CONTROL RULES BY FEB. 19

By AuntMinnie.com
The U.S. Food and Drug Administration (FDA) has issued a draft guidance for an update to its radiation control regulations covering the manufacturing of diagnostic x-ray equipment.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 Feb. 19.

 

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Larry Storer

Larry Storer

Larry Storer has been editor of Vein Therapy News for 10 years. He has edited computer, shelter and medical publications at Publications & Communications LP for 30 years. He was also a corporate vice president and editorial director before retiring. Larry graduated from Baylor University with a BA in journalism and an MA in communications; and from Lamar University with a MED in school administration. He taught beginning and advanced reporting, beginning and advanced editing and editorial writing at Baylor University. Larry was a reporter, and city and news editor of the Beaumont Journal, and opinion editor at the Beaumont Enterprise and Beaumont Enterprise-Journal. He was also the founding managing editor of the Yuba City (California) Daily Independent-Herald.