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FDA voluntary standards guidance

This article was originally published in The Gray Sheet

Executive Summary

Document outlining how the device center will use voluntary standards is scheduled for release at a March 24-25 Association for the Advancement of Medical Instrumentation/FDA conference in Washington, D.C. The document, which will also address when the device center will get involved in developing standards, currently is under review at FDA's office of general counsel. CDRH announced development of the guidance at an AAMI/FDA conference in November ("The Gray Sheet" Nov. 16, p. 23). For information on the upcoming March meeting contact Laura Duffy of AAMI at 703/525-4890, ext. 260.
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