FDA News In Brief
This article was originally published in The Gray Sheet
Executive Summary
MDUFMA pediatric study: Institute of Medicine study mandated by user-fee act to assess adequacy of postmarket surveillance for devices used in pediatric populations will begin after appointment of committee members this fall, according to FDA staffers. An initial committee meeting to discuss the nature and scope of the study is expected to take place early next year. Under MDUFMA, FDA is to report to Congress on the results of the study by Oct. 26, 2006. The device center already has fulfilled pediatric provisions in MDUFMA that required the agency to issue guidance on pediatric clinical trial protections and safety and effectiveness criteria (1"The Gray Sheet" July 28, 2003, p. 14)...