Each fiscal year, FDA obligates funds for postmarket compliance activities  and inspections related to medical devices and radiological products. FDA may  (1) issue an order approving the application, which allows the  manufacturer to begin marketing the device; (2) send the manufacturer an  approvable letter pending a GMP inspection, which indicates that FDA  should be able to approve the device after the agency finds that the  manufacturer’s device establishment is in compliance with GMP  requirements; (3) send the manufacturer an approvable letter indicating  that the agency should be able to approve the device if the manufacturer  can make minor corrections or clarifications to the application; (4) issue a  “not approvable” letter informing the manufacturer that FDA does not  believe that the application can be approved because the data provided by  the manufacturer do not demonstrate that the device is reasonably safe and  effective; or (5) issue an order denying approval of the application, which  informs the manufacturer that the agency has completed its scientific  review, identified major safety and effectiveness problems, and decided not  to approve the application. Limited Data to Measure FDA’s Performance against the MDUFMA Performance Goals

FDA had limited data that could be used to measure the agency’s  performance against most of the MDUFMA performance goals. Thus, it is  uncertain whether FDA will meet the MDUFMA performance goals for  fiscal years 2003, 2004, and 2005. However, as of March 31, 2004,  only one application was subject to a cycle action tied to one of the two  MDUFMA performance goals. For fiscal  year 2004, there were no applications subject to the cycle action tied to the  two fiscal year 2004 MDUFMA performance goals. In addition, the  likelihood of FDA meeting the fiscal year 2005 MDUFMA performance  goals is uncertain because FDA had performance data for some, but not all,  of the MDUFMA performance goals that will be effective in fiscal year 2005. Limited Data to Measure FDA’s Performance against the MDUFMA Performance Goals Established for Fiscal Years 2003 and 2004

Limited data exist to measure FDA’s performance against the two  MDUFMA performance goals established for fiscal years 2003 and 2004. Therefore, FDA’s performance results  are preliminary. Because FDA’s performance against the  MDUFMA performance goals is based on the percentages of actions the  agency takes on applications within required review times, FDA’s  performance results could change as the agency completes actions on all  applications for which the performance goals apply. Data were not readily  available from FDA on the status of all pending applications within the  review process. For example, from the fiscal  year 2003 cohort, data were available to compare FDA’s performance  against 17 of the 20 performance goals for fiscal year 2005. FDA took  actions on applications tied to 14 of the 17 performance goals within the  established goal time frames. We found that  FDA took actions on applications tied to each of the 11 performance goals  within the established goal time frames. As previously mentioned, many of the applications from the fiscal years  2003 and 2004 cohorts are awaiting actions by FDA or responses from  manufacturers. FDA Obligated over $128 Million for Postmarket Medical Device Compliance Activities and Inspections in Fiscal Year 2002

In fiscal year 2002, FDA obligated about $128 million for postmarket  medical device compliance activities, which include inspections of device  manufacturers’ establishments. FDA obligated about $109 million for  compliance activities and about $19 million for inspections. Outreach coordination included  funds for guidance to field staff on matters such as the reporting of  problems with medical devices, epidemiology studies, device recalls, and  other activities. Obligations for applied research included funding for  activities such as the development of domestic and international standards  to help provide reasonable assurance that medical devices are safe and  effective. These inspections  included routine surveillance inspections to determine compliance with  medical device regulations, inspections resulting from the reporting  problems with devices or product recalls, and compliance inspections to  collect evidence for pending enforcement actions.
Why GAO Did This Study

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.

What GAO Found

FDA had limited data that could be used to measure the agency's performance against most of the MDUFMA performance goals. Thus, it is uncertain whether FDA will meet the MDUFMA performance goals for fiscal years 2003, 2004, and 2005. For fiscal years 2003 and 2004, there were two performance goals in effect for each year. As of March 31, 2004, only one application was subject to the action tied to one of the two MDUFMA performance goals. On this application, FDA completed its review and made the decision to approve the application within the goal's established time frame. To determine the likelihood of meeting the 20 MDUFMA performance goals for fiscal year 2005, FDA is collecting data on its performance against these goals. GAO found that FDA had performance data for some, but not all, of the MDUFMA performance goals. From fiscal year 2003 applications, data were available to compare FDA's performance against 17 of the 20 fiscal year 2005 performance goals. FDA took actions tied to 14 of the 17 goals within the goals' established time frames. From fiscal year 2004 applications, data were available to compare FDA's performance against 11 of the 20 performance goals. FDA took actions tied to the 11 goals within the goals' established time frames. The results of FDA's performance against MDUFMA performance goals are preliminary, however, because 8 percent and 49 percent, respectively, of the applications FDA accepted in fiscal year 2003 and the first 6 months of fiscal year 2004 were awaiting action by FDA or responses from manufacturers. Because FDA's performance against the MDUFMA performance goals is based on the percentages of actions the agency takes within required review times, FDA's results could change as the agency completes its actions on all applications for which the goals apply. FDA obligated about $128 million for postmarket medical device compliance activities and inspections in fiscal year 2002. FDA obligated about $109 million for compliance activities for outreach coordination, such as guidance to field staff on reporting problems with medical devices, laboratory analyses, and research, such as the development of domestic and international standards to provide reasonable assurance that medical device products are safe and effective. FDA obligated about $19 million for inspections of device manufacturers' establishments, including routine surveillance inspections to determine compliance with medical device regulations and inspections resulting from device problem reporting or product recalls.