Medical Devices: FDA's Forecasts of Problem Reports and FTEs Under H.R. 4640 : Report to the Chairman, Subcommittee on Health and the Environment, Committee on Energy and Commerce, House of Representatives |
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Accounting Office addi additional FTEs additional reports agency staff Analysis and Findings analyze the additional analyze those reports analyzing reports asso average Beth Israel Chairman ciated copies current number current staff allocation data base data Source decline derived device problem reports device-related prob devices reporting regulation Director enactment of H.R. estimate evaluate FDA has received FDA projected FDA's forecast FTEs required FTEs to process FTEs Under H.R. GAO/PEMD-88-30 Medical-Device Problem hospital bed implementation increase inter Israel's HERS project lem reports medical device problems medical devices reporting Medical-Device Problem Reports ments Methodology number of beds number of FTEs number of medical number of problem number of reports peak shortly population problems per hospital process and analyze program received approximately 18,000 related studies relatively unique Reports and FTEs reports annually reports that FDA representative request required to process results sample significantly statistical tional total number U.S. General Accounting U.S. hospitals