FDA’s Medical Device Application Review Processes

Each of the 2005 and 2006 MDUFMA performance goals are linked to  actions FDA takes under one of three processes for reviewing medical  device applications: the PMA review process, the 510(k) review process,  and the BLA review process. 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 determines 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 or effectiveness problems, and decided not  to approve the application. When FDA did not have sufficiently complete data  to evaluate performance against a MDUFMA performance goal, we  reviewed preliminary data and found that FDA took actions tied to most of  these other fiscal year 2005 goals within specified time frames. Our analysis shows that FDA met most of the MDUFMA 2005 performance  goals for which there were sufficiently complete data to measure  performance (see fig. These data were from applications that FDA  received in fiscal years 2003 and 2004 and were used to measure the  agency’s performance against about half of the performance goals  established for fiscal year 2005. As of March 31, 2005, FDA had sufficiently  complete data from applications received in fiscal year 2003 to measure  performance against 11 of the 20 goals established for fiscal year 2005. FDA met 9 of those 11 goals and did not meet 2 of them. As of March 31, 2005, FDA  had preliminary data from applications received in fiscal year 2003 on 7 of  the 9 performance goals for fiscal year 2005 for which data were not  sufficiently complete to evaluate performance. FDA took actions tied to  these 11 goals within the specified time frames. Based on the limited data that were available as of March 31, 2005, it is  unclear whether or to what extent FDA will meet the fiscal year 2005  MDUFMA performance goals because the agency’s performance could  change as the agency completes its review of applications. Limited Available Data Suggest That FDA is Likely to Meet Some Performance Goals Established for Fiscal Year 2006

The limited data available on FDA’s performance suggest that FDA is  likely to meet some of its fiscal year 2006 performance goals. Our analysis  of FDA’s performance for applications received in fiscal years 2003 and  2004 shows that FDA has been meeting most of the MDUFMA 2006  performance goals for which it had sufficiently complete data. We also  reviewed FDA’s preliminary data from applications received in fiscal years  2003 and 2004 and the first 6 months of fiscal year 2005, and found that  FDA took actions tied to most of the remaining fiscal year 2006 goals  within specified time frames. Preliminary performance results could  change as the agency completes actions for applications received in fiscal  years 2003, 2004, and 2005 and FDA’s performance could change as it  receives applications in fiscal year 2006. As of March 31, 2005, FDA had sufficiently  complete data from applications received in fiscal year 2003 to measure  performance against 14 of 26 goals established for fiscal year 2006. FDA  met 12 of those 14 goals. FDA also had sufficiently complete data from  applications received in fiscal year 2004 to measure performance against  12 performance goals and met 9 of those 12 goals. In general, when sufficient data indicated that FDA’s performance results  for applications received in a fiscal year met the performance goal  established for fiscal year 2005, then the agency also met the performance  goal established for fiscal year 2006, even when the 2006 goal required  FDA to take action within specified time frames on a greater percentage of  applications. To help meet its MDUFMA performance goals, FDA has taken several  steps consistent with those outlined by the Secretary of Health and Human  Services in his November 2002 letter establishing those goals.
Why GAO Did This Study

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.

What GAO Found

Limited available data indicate that FDA has been meeting some MDUFMA performance goals established for fiscal year 2005. It is uncertain, however, whether FDA will meet all of the goals. FDA met most of the MDUFMA 2005 performance goals for which data were sufficiently complete to measure the agency's performance. As of March 31, 2005, FDA had sufficiently complete data from applications received in fiscal year 2003 to measure performance against 11 of the 20 goals established for fiscal year 2005. FDA met 9 of those 11 goals. For applications received in fiscal year 2004, FDA had sufficiently complete data to measure performance against 10 goals and met 9 of them. When FDA did not have sufficiently complete data to evaluate performance, GAO reviewed preliminary data from applications received in fiscal years 2003, 2004, and 2005. These data suggest that FDA has taken actions tied to many of the fiscal year 2005 goals within specified time frames. These data are preliminary because some applications from each year were pending within the review process and FDA could receive and act on additional applications or amendments to applications. For example, as of March 31, 2005, about half of the applications FDA had received in fiscal year 2005 were pending 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 on applications within required time frames, FDA's performance results could change as the agency completes actions on all applications and amendments for which the performance goals apply. The limited data available on FDA's performance suggest that FDA is likely to meet some fiscal year 2006 performance goals. GAO's analysis of FDA's past performance shows that FDA met most of the MDUFMA 2006 performance goals for which it had sufficiently complete data to evaluate its performance. As of March 31, 2005, FDA has sufficiently complete data from applications received in fiscal year 2003 to measure performance against 14 of 26 goals established for fiscal year 2006. FDA met 12 of those 14 goals. FDA also had sufficiently complete data from applications received in fiscal year 2004 to measure performance against 12 performance goals and met 9 of those 12 goals. GAO also reviewed preliminary data from applications FDA received in fiscal years 2003, 2004, and 2005 and found that FDA took actions tied to many of the fiscal year 2006 goals within specified time frames. Most of these results are preliminary, however, and FDA's performance could change as the agency completes actions for applications received in fiscal years 2003, 2004, and 2005 and receives applications in fiscal year 2006. FDA concurred with GAO's findings.