Food and Drug Administration: Limited Available Data Indicate That FDA Has Been Meeting Some Goals for Review of Medical Device Applications

United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 2005-09-30 monographic deposited born digital 35 p. GA 1.13:GAO-05-1042 https://www.govinfo.gov/app/details/GAOREPORTS-GAO-05-1042 P0b002ee1803a3246 f:d051042 DGPO 2010-08-12 2011-03-24 GAOREPORTS-GAO-05-1042 machine generated eng fdlp REPORT GAOREPORTS-GAO-05-1042 GAO-05-1042 Data collection Medical equipment Performance measures Program evaluation Reporting requirements User fees Performance plans Other Written Product A38817 Food and Drug Administration: Limited Available Data Indicate That FDA Has Been Meeting Some Goals for Review of Medical Device Applications The Food and Drug Administration (FDA) reviews applications from manufacturers that wish to market medical devices in the United States. To facilitate prompt approval of new devices and clearance of devices that are substantially equivalent to those legally on the market, the Congress passed the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The act authorizes FDA to collect user fees from manufacturers and, in return, requires FDA to meet performance goals tied to the agency's review process. These goals are linked to certain actions FDA may take during the application review process. The goals specify lengths of time for taking these actions and the percentage of actions the agency is to take within specified time frames. MDUFMA requires GAO to report on whether FDA is meeting performance goals established by the Secretary of Health and Human Services for fiscal year 2005 and whether FDA is likely to meet the goals established for fiscal year 2006. GAO analyzed data provided by FDA that are based on actions taken on applications FDA received from October 1, 2002, through March 31, 2005. GAO used FDA's performance on applications received in fiscal years 2003 and 2004 as an indicator of the agency's likely performance. https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-05-1042/html/GAOREPORTS-GAO-05-1042.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-05-1042/pdf/GAOREPORTS-GAO-05-1042.pdf GAO-05-1042 https://www.govinfo.gov/app/details/GAOREPORTS-GAO-05-1042 Other Written Product GAO-05-1042; Food and Drug Administration: Limited Available Data Indicate That FDA Has Been Meeting Some Goals for Review of Medical Device Applications; Data collection Medical equipment Performance measures Program evaluation Reporting requirements User fees Performance plans United States Statutes at Large Volume 52 Page 1040 52 Stat. 1040 United States Statutes at Large Volume 116 Page 1588 116 Stat. 1588 United States Statutes at Large Volume 119 Page 439 119 Stat. 439