TY - BOOK AU - Lepakbin, Dr Vladimir K. ED - United States. TI - Medical device regulation: too early to assess European system's value as model for FDA : report to the Chairman, Committee on Labor and Human Resources, U.S. Senate PY - 2003///] CY - Washington, D.C., Gaithersburg, MD (P.O. Box 6015, Gaithersburg 20884-6015) PB - The Office, The Office [distributor KW - United States KW - Food and Drug Administration KW - Medical instruments and apparatus KW - Safety regulations KW - Europe KW - Evaluation KW - Medical instruments and apparatus industry KW - Government policy N1 - Cover title; Shipping list no.: 96-0483-M; "March 1996."; "GAO/HEHS-96-65."; "B-260738"--P. 1; Includes bibliographical references; Also available via Internet from the GPO Access web site. Address as of 5/8/2001: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=gao&docid=f:he96065.pdf; current access is available via PURL UR - http://www.gao.gov/docsearch/keyword.php ER -