CBER Should Retain Jurisdiction of Assigned Device Reviews – HHS Report
This article was originally published in The Gray Sheet
Executive Summary
Improved device review times, including speedy handling of West Nile Virus diagnostics, convinced HHS that the Center for Biologics Evaluation & Research should retain jurisdiction over blood and tissue-related devices already assigned to the center
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Greater Modular Program Familiarity Needed To Set Performance Goals – FDA
FDA will defer issuing modular PMA performance goals until gaining more familiarity with the recently- codified process, agency officials informed attendees Dec. 3 at the MDUFMA one-year meeting in Gaithersburg, Md
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