Food and Drug Administration: Data to Measure the Timeliness of Reviews of Medical Device Applications Are Limited;Report to the Congress

摘要

FDA reviews applications from manufacturers that wish to market medical devices in the United States. To ensure 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 and, in return, requires FDA to meet performance goals that are tied to the agency's review process. The goals set actions FDA may take on applications and specify the time that FDA should take in certain phases of the review process. MDUFMA requires GAO to report on FDA's performance against the MDUFMA performance goals established for fiscal years 2003 and 2004 and to determine whether FDA is likely to meet the fiscal year 2005 performance goals. MDUFMA also requires GAO to report on the amounts FDA obligated in fiscal year 2002 for medical device compliance activities and inspections of manufacturers after their devices are marketed. GAO analyzed data provided by FDA that are based on actions taken on applications FDA received from October 1, 2002, through March 31, 2004. GAO also analyzed data on the amounts FDA obligated for medical device compliance and inspection activities for fiscal year 2002.