Revised secondary reagents guidance will address IVD performance criteria -- FDA's Gutman.
This article was originally published in The Gray Sheet
Executive Summary
IVD SECONDARY REAGENT GUIDANCE REVISIONS TO BE COMPLETED in the next several weeks, FDA staffers say. The changes seek to clarify two provisions of the June 1996 guidance, Steve Gutman, director of the Division of Clinical Laboratory Devices in FDA's Center for Devices and Radiological Health, said Sept. 8 at the Regulatory Affairs Professionals Society annual meeting in Washington, D.C.