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HEHS-94-86R 1 (1994-02-10)

handle is hein.gao/gaobackml0001 and id is 1 raw text is: A United States General Accounting Office Washington, D.C. 20548 Human Resources Division B-256207 February 10, 1994 The Honorable John D. Dingell Chairman, Committee on Energy and Commerce House of Representatives The Honorable Carlos J. Moorhead Ranking Minority Member Committee on Energy and Commerce House of Representatives The Honorable Edward M. Kennedy Chairman, Committee on Labor and Human Resources United States Senate The Honorable Nancy Landon Kassebaum Ranking Minority Member Committee on Labor and Human Resources United States Senate The Safe Medical Devices Act of 1990 (P.L. 101-629, Nov. 28, 1990) requires that we report no later than August 1994 on (1) device user facilities' compliance with the act's reporting requirements, (2) corrective actions manufacturers are taking in response to problem reports received, and (3) the cost effectiveness of the act's requirements and implementation. The act also requires that the Secretary of Health and Human Services (HHS) report no later than November 1993 on such matters as the safety benefits of the act's , requirements, the burdens placed on the Food and Drug Administration (FDA) and device user facilities by the act, and the cost effectiveness of the act's requirements. This letter describes our work to date and confirms agreements reached with your offices to delay completing our study because FDA has not yet issued the final regulations required by the act and its new reporting system has not yet produced much data from device user facilities. As of January 1994, FDA has not published theifinal regulation covering how user facilities, distributors, and manufacturers are to report device problems. The final GAO/HEHS-94-86R Safe Medical Devices

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