Food and Drug Administration: Limited Available Data Indicate That FDA Has Been Meeting Some Goals for Review of Medical Device Applications
Published: 2005-09-30T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: The Food and Drug Administration (FDA) is responsible for regulating  medical devices—such as tongue depressors, pacemakers, and artificial  hearts—to provide reasonable assurance that they are safe and effective  for human use. As part of its regulatory responsibilities, FDA reviews  applications from manufacturers that wish to market their medical devices  in the United States, including new devices and devices that may be  substantially equivalent to those already on the market. When required,  FDA also inspects manufacturers’ establishments prior to making a  decision. Each year FDA receives approximately 10,000 medical device  applications. Members of the Congress, representatives of the medical  device industry, and others have expressed concern that the length of time  it takes FDA to review applications for marketing medical devices could  delay patients’ access to useful, and possibly life-saving, medical devices.
In October 2002, the Congress passed the Medical Device User Fee and  Modernization Act of 2002 (MDUFMA) to provide FDA with additional  resources to ensure prompt approval or clearance of applications for  marketing medical devices and licensing biological products. MDUFMA  authorized FDA to collect user fees from manufacturers that submit  several types of applications to FDA for marketing medical devices. In  return, MDUFMA requires FDA to meet performance goals tied to the  review of certain medical device and biological license applications, at  least to the extent practicable. MDUFMA also required the Secretary of  Health and Human Services to develop the specific goals FDA must meet.  The Secretary developed performance goals for fiscal years 2003 through  2007. To help FDA meet the MDUFMA performance goals, the Secretary  also identified several goal-related activities for FDA to undertake, such as  hiring additional review staff.
MDUFMA performance goals are linked to certain actions FDA may take  during the application review process and specify lengths of time for  taking these actions. Data to measure FDA’s performance against the  MDUFMA performance goals are based on the percentages of actions the  agency takes on applications within specified time frames. For example,  one of the performance goals is linked to the time it takes FDA to review  and make a decision about certain applications to market devices that may  be substantially equivalent to devices that are already on the market. To  meet the performance goal established for fiscal year 2005, FDA must  reach a decision about substantial equivalence within 90 days for   75 percent of such applications received in the fiscal year. In general, the  time frames established by MDUFMA performance goals do not hold FDA  accountable for the time it takes manufacturers to respond to the agency if  the agency determines that substantial additional information is needed  before a decision can be reached.
The number of MDUFMA performance goals that FDA must meet  increases over time, and the percentage of actions taken within the  specified time frame for some goals also increases over time. For fiscal  years 2003 and 2004, FDA was to meet the same 2 performance goals for  each year. For fiscal year 2005, FDA was to meet those 2 goals and an  additional 18 performance goals, for a total of 20. For fiscal year 2006, FDA  is to meet these 20 goals and an additional 6 performance goals, for a total  of 26. The goals established for fiscal year 2006 are tied to more types of  applications than the goals established for fiscal year 2005. In addition, 16  of the performance goals established for fiscal year 2006 require that  review actions be taken within the specified time frames on a higher  percentage of applications—for example, on 80 percent rather than   75 percent of the applications—than was required for similar goals  established for fiscal year 2005.
MDUFMA requires us to report on FDA’s performance as measured  against these performance goals. Our first report, issued in August, 2004,  indicated that FDA had limited data that could be used to measure the  agency’s performance. As a result, it was uncertain whether FDA would  meet the MDUFMA performance goals for fiscal years 2003, 2004, or 2005.  As we reported, FDA’s performance data were preliminary, in part because  many of the applications received in fiscal year 2003 and the first 6 months  of fiscal year 2004 were pending within the review process, that is,  awaiting action by FDA or responses from manufacturers. Because FDA  measures its progress in meeting the MDUFMA performance goals by the  percentage of actions the agency takes within specified time frames, we  noted that performance results could change as FDA completes its actions  on these applications.
This report responds to the MDUFMA requirement that we report on  whether FDA is meeting the MDUFMA performance goals established for  fiscal year 2005 and whether FDA is likely to meet the goals established  for fiscal year 2006. To assess FDA’s performance against the 20  MDUFMA performance goals that were established for fiscal year 2005, we  analyzed performance data from applications the agency received during  the first 6 months of fiscal year 2005. To supplement the data from the first  6 months of fiscal year 2005, we also compared FDA’s actions on  applications received in fiscal years 2003 and 2004 against the 20  MDUFMA performance goals established for fiscal year 2005, a  comparison FDA also conducts. We used FDA’s performance on  applications received in fiscal years 2003 and 2004 as an indicator of the  agency’s experience in meeting the fiscal year 2005 goals and therefore its  likely performance in fiscal year 2005. Similarly, to determine the  likelihood of FDA meeting its fiscal year 2006 MDUFMA performance  goals, we compared performance data from applications the agency  received in fiscal years 2003 and 2004 and the first 6 months of fiscal year  2005 with the 26 MDUFMA performance goals that will be effective in  fiscal year 2006. In other words, we analyzed performance data collected  by FDA for actions taken on all applications that were tied to performance  goals established for fiscal years 2005 or 2006 that the agency received  from fiscal year 2003 through the first 6 months of fiscal year 2005 (Oct. 1,  2004, through Mar. 31, 2005).
In conducting our work, we made a distinction between data that were  sufficiently complete to evaluate FDA’s performance and preliminary data  that were not sufficiently complete for that purpose. FDA’s data for some  MDUFMA performance goals were not complete because applications  were pending within the review process or because manufacturers can  submit additional applications or amendments to their applications. We  defined the data as sufficiently complete to evaluate performance when  we could determine whether FDA would or would not meet the  performance goal. For example, FDA had data on eight of nine  applications tied to one performance goal and took action within the  specified time frame for each of those eight applications. These data were  sufficiently complete to evaluate FDA’s performance because the action  was taken within the specified time frame for at least 75 percent of  applications—the percentage established for this performance goal. In  contrast, when FDA’s data were not sufficiently complete to evaluate  performance, we considered data on FDA’s performance to be  preliminary.
To conduct our work and to determine what steps FDA has taken to help  meet its MDUFMA goals, we also reviewed our previous work on FDA’s  performance as measured by MDUFMA performance goals, reviewed  relevant documents, and interviewed officials from FDA’s Center for  Devices and Radiological Health (CDRH) and Center for Biologics  Evaluation and Research (CBER). In addition, we reviewed FDA’s  procedures for verifying the accuracy and consistency of reported  performance data. We determined that the performance data were  sufficiently reliable for the purposes of this report. We conducted our  work from May 2005 through September 2005 in accordance with  generally accepted government auditing standards.
subsections: section_title: Background
paragraphs: Under the Federal Food, Drug, and Cosmetic Act, FDA is responsible for  ensuring that medical devices are reasonably safe and effective before  they go to market (premarket) and that marketed device products remain  safe (postmarket). Two FDA centers, CDRH and CBER, are responsible  for reviewing applications to market medical devices. CDRH reviews  applications for the majority of these devices, such as artificial hearts,  dialysis machines, and radiological devices. CBER reviews applications for  devices used in the testing and manufacture of biological products,  including diagnostic tests intended to screen blood donors (such as for the  human immunodeficiency virus), as well as therapeutic devices used in  cell and gene therapies. FDA also inspects manufacturers’ establishments  to assess compliance with good manufacturing practices (GMP). During  these inspections, FDA investigators examine manufacturing facilities,  records of manufacturing processes, and corrective action programs.
subsections: section_title: Types of Applications Reviewed under MDUFMA Performance Goals
paragraphs: Nine types of applications for medical devices and biological products are  subject to the MDUFMA performance goals established by the Secretary of  Health and Human Services for fiscal years 2005 or 2006:  Original Premarket Approval (PMA) applications are generally required  when the device is new or when the risks associated with the device are  considerable (as would be the case if the device is to be implanted in the  body for life-supporting purposes).
Expedited PMAs are used when FDA has granted priority status to an  application to market a medical device because it is intended to treat or  diagnose a life-threatening or irreversibly debilitating disease or condition  and to address an unmet medical need.
Premarket Reports are applications required for high-risk devices  originally approved for a single use (that is, use on a single patient during a  single procedure) that a manufacturer has reprocessed for additional use.
Premarket Notifications, or 510(k)s, are applications used when the intent  is to market a type of device that may be substantially equivalent to a  legally marketed device that was not subject to premarket approval.
Panel-Track Supplements are applications used to supplement approved  PMAs or Premarket Reports. These supplements typically request  approval of a significant change in the design or performance of a device,  or for a new purpose for using a device.    180-Day PMA Supplements are also used to supplement approved PMAs or  Premarket Reports. These supplements typically request approval of a  significant change in aspects of a device, such as its design, specifications,  or labeling, when demonstration of reasonable assurance of safety and  effectiveness either does not require new clinical data or requires only  limited clinical data.
Biologics license applications (BLA) request permission to introduce and  license biological products into interstate commerce. There are two types  of BLAs that are tied to MDUFMA performance goals. Priority BLAs are  for products that would, if approved, involve a significant improvement in  the safety or effectiveness of the treatment, diagnosis, or prevention of a  serious or life-threatening disease. Nonpriority BLAs are considered  standard BLAs.
BLA Supplements are used to supplement approved BLAs by requesting  approval of a change to a licensed biological product. When the change  has the substantial potential to affect the safety or effectiveness of the  product, FDA approval is required prior to product distribution. There are  MDUFMA performance goals linked to three types of BLA supplements— BLA manufacturing supplements that require prior approval and two types  of BLA efficacy supplements. Manufacturing supplements that require  prior approval address proposed changes in the manufacture of the  biologic and generally do not require submission of substantive clinical  data. Efficacy supplements include both standard and priority efficacy  supplements and require submission of substantive clinical data.
BLA Resubmissions and BLA Efficacy Supplement Resubmissions are  used to respond to a letter from FDA indicating that the information  included in a BLA or BLA Efficacy Supplement was deficient. FDA  classifies these resubmissions into two groups according to the type of  information they provide. For Class 1 resubmissions, the new information  may include matters related to product labeling, safety updates, and other  minor clarifying information. For Class 2 resubmissions, the new  information could warrant presentation to an advisory committee or a  reinspection of the manufacturer’s device establishment.
section_title: FDA’s Medical Device Application Review Processes
paragraphs: 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.
subsections: section_title: The PMA Review Process
paragraphs: Under the PMA review process, FDA reviews applications for new devices  or those for which risks associated with the device are considerable.  Applications reviewed under this process include Original PMAs,  Expedited PMAs, Premarket Reports, Panel-Track Supplements, and 180- Day PMA Supplements. After an initial screening of an application and  determination that the review should proceed, FDA multidisciplinary  staff conduct a scientific review of the application. (See fig. 1.) If FDA  determines that it needs significant additional information to complete its  scientific review, FDA issues a “major deficiency letter” to the  manufacturer identifying the information that is required. The  manufacturer can respond to FDA’s request by submitting an amendment  to the original application. FDA then proceeds with its review of the  amended application. FDA can issue additional major deficiency letters  and review additional amendments until FDA determines that it has  sufficient information to make a decision. As part of its review, FDA may  refer applications to an external advisory committee for evaluation. FDA  takes this step when a device is the first of its kind or when the agency  believes it would be useful to have independent expertise and technical  assistance to properly evaluate the safety and effectiveness of the device.  For applications referred to an advisory committee, the committee  provides input to FDA on the safety and effectiveness of the devices.
Taking the committee’s input into consideration, FDA then makes a  decision.
FDA may make one of five decisions. 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.
Two of these possible decisions result in issuance of letters indicating that  an application has informational deficiencies—approvable letters  requesting minor corrections or clarifications and not approvable letters.  The manufacturer can respond to these letters by submitting an  amendment to the original application. FDA then reviews the amendment.  FDA can issue additional letters indicating that information is deficient  and review additional amendments until FDA determines that it has  sufficient information to determine whether to approve or deny the  application. For example, if FDA determines that a manufacturer’s  amendment to an approvable letter requesting minor corrections or  clarifications does not address all of FDA’s questions, then FDA can issue  another approvable letter pending minor corrections or clarifications or a  not approvable letter.
section_title: The 510(k) Review Process
paragraphs: Under the 510(k) review process, FDA reviews applications to market a  device that may be substantially equivalent to a legally marketed device  that was not subject to premarket approval (see fig. 2). FDA staff conduct  a scientific review of the application. When a 510(k) application lacks  information necessary for FDA to reach a decision, the agency may issue  an “additional information” letter that indicates that the information is  insufficient. The manufacturer may then submit additional information.  Once FDA has obtained sufficient information from the manufacturer,  FDA may make one of three decisions: FDA may decide that (1) the device  is substantially equivalent and therefore may be marketed, (2) the device is  not substantially equivalent and may not be marketed, or (3) a 510(k)  application was not required because the product is not regulated as a  device or the device is exempt from the requirements for premarket  notification.
Under the BLA review process, FDA determines whether to approve  licenses for biological products (see fig. 3). Applications reviewed under  this process include BLAs, BLA Supplements, BLA Resubmissions, and  BLA Supplement Resubmissions. After an initial screening of an  application and determination that the review should proceed, staff  conduct a multidisciplinary scientific review of the application. As part of  its review, FDA may refer applications to an external advisory committee.  After reviewing the application and taking into consideration any input  from an external advisory committee, FDA may make one of two  decisions. FDA may issue (1) an approval letter or (2) a “complete  response” letter, which informs the manufacturer of deficiencies in the  information provided in the application. The manufacturer can provide the  information specified in a “complete response” letter in a BLA  Resubmission or BLA Supplement Resubmission.
section_title: Measuring FDA’s Performance under MDUFMA
paragraphs: The MDUFMA performance goals specify a length of time for taking an  action during the review process, which can include making a decision.  The goals designate a certain percentage of these actions that must occur  within the specified period for FDA to meet the performance goals. To  assess its performance against the MDUFMA performance goals, FDA  measures the time the agency takes to complete certain actions and make  decisions—but not the time it takes a manufacturer to respond to a letter  from FDA.
The data for measuring FDA’s performance against a specific fiscal year’s  MDUFMA performance goals are based on all the applications the agency  received in that year, known as a cohort, and are not complete until all  applicable actions have been taken. As a result, data are preliminary until  FDA has completed all actions tied to the goal for all applications in a  cohort—a process that, for PMAs, can take up to 3 or 4 years. For  example, one performance goal established for fiscal year 2005 is tied to  amendments to PMAs that are submitted in response to major deficiency  or not approvable letters. Data on FDA’s performance on this goal will not  be complete until after FDA has issued all major deficiency and not  approvable letters it decides to issue for applications received in fiscal  year 2005 and then either (1) received, reviewed, and acted on all  amendments submitted in response or (2) determined that manufacturers  have withdrawn their applications.
For fiscal year 2005, FDA is to meet 20 performance goals and for fiscal  year 2006 FDA is to meet an additional 6 performance goals, for a total of  26. (See table 1.) The percentage of applications for which the action must  be taken within the specified time frame is higher in fiscal year 2006 than  in fiscal year 2005 for 16 of the performance goals that are applicable for  both years.
section_title: Limited Available Data Indicate That FDA Has Been Meeting Some Performance Goals Established for Fiscal Year 2005
paragraphs: The limited data available indicate that FDA has been meeting some  MDUFMA performance goals established for fiscal year 2005. It is  uncertain, however, whether FDA will ultimately meet the fiscal year 2005  performance goals once reviews for all the applications are complete. We  found that FDA met most of the MDUFMA fiscal year 2005 performance  goals for which there were sufficiently complete data to measure the  agency’s performance. 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. Data from  the first 6 months of fiscal year 2005 are not sufficiently complete to  evaluate FDA’s performance against MDUFMA performance goals because  some applications are pending review and because manufacturers are  likely to submit additional applications and amendments for review.
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. 4). 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. For applications  received in fiscal year 2004, FDA had sufficiently complete data to  measure performance against 10 of the 20 goals. It met 9 and did not meet  1 of these goals. For example, one of FDA’s 2005 performance goals  requires the agency to issue a first major deficiency letter within 150 days  for 75 percent of PMAs, Panel-Track Supplements, and Premarket Reports  that the agency received during the fiscal year and found to be incomplete.  For applications in the fiscal year 2003 and 2004 cohorts, respectively,  FDA issued 22 of 26 (85 percent) and 23 of 28 (82 percent) first major  deficiency letters within 150 days, thus meeting the goal. FDA had  complete data on its performance against this performance goal from both  the fiscal year 2003 and 2004 cohorts—there were no other applications  that FDA received during these years for which a first major deficiency  letter can be issued. Figure 4 also shows that FDA had sufficiently  complete data on applications received in both fiscal years 2003 and 2004  on 2 performance goals established for fiscal year 2005 that are tied to  510(k) applications, the type of MDUFMA-related medical device  application that FDA receives most frequently. These data indicate that  FDA met 1 of the 2 goals with applications received in fiscal year 2003 and  met both goals for applications received in fiscal year 2004. Sufficiently  complete data were also available on applications received in fiscal years  2003 and 2004 to evaluate FDA’s performance on 3 of the 2005  performance goals tied to 180-Day PMA Supplements, the type of  MDUFMA-related application that FDA receives second most frequently.  FDA met 2 of these 3 goals on applications received in 2003 and met the 3  goals on applications received in 2004.
As figure 4 shows, FDA’s data from applications received in fiscal years  2003 and 2004 and the first 6 months of fiscal year 2005 are not sufficiently  complete to evaluate the agency’s performance against some fiscal year  2005 goals. The preliminary data available on these goals suggest that  when FDA took actions tied to fiscal year 2005 performance goals, it  generally did so within specified time frames. 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 5  of the 7 goals within the specified time frames. For applications received  in fiscal year 2004, FDA had preliminary data for 7 of the 10 performance  goals for which data were not sufficiently complete, and the agency took  actions tied to these 7 goals within the specified time frames. FDA also  had preliminary performance data from applications received in the first 6  months of fiscal year 2005 for 11 of the 20 goals. FDA took actions tied to  these 11 goals within the specified time frames. These preliminary results  could change as FDA completes its review of pending applications and  additional applications or amendments. For example, one of FDA’s 2005  performance goals for expedited PMAs was to take action within 170 days  for 70 percent of amendments containing complete responses to a major  deficiency or not approvable letter. As of March 31, 2005, FDA had taken  action within 170 days on two of two such amendments (100 percent) to  applications in the fiscal year 2003 cohort and four of five (80 percent) in  the fiscal year 2004 cohort and had received no such amendments for  applications in the fiscal year 2005 cohort. These preliminary performance  results could change, however, if manufacturers submit additional  amendments to applications in any of the three cohorts.
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. For example,  some applications are pending review because FDA has not reached a  decision about the application or because the manufacturer has not  responded to a letter from FDA indicating that the application included  insufficient information for FDA to complete its review. Our analysis  shows that as of March 31, 2005, about half of the applications FDA had  received during the first 6 months of fiscal year 2005—831 of 1,792—were  pending. (See table 2, which also shows the number of pending  applications from the fiscal year 2003 and 2004 cohorts.) The percentage  of pending applications varied by application type. For example, for the  fiscal year 2005 cohort, 22—95.7 percent—of 23 PMAs and Panel-Track  Supplements were pending further action, while 4—33.3 percent—of 12  BLA Supplements were pending.
As previously noted, FDA’s preliminary performance results could also  change if manufacturers submit additional applications or amendments, as  is likely. For example, FDA received 1,703 510(k) applications during the  first 6 months of fiscal year 2005, about half the number it received in each  of the 2 preceding full fiscal years (3,805 and 3,432 for fiscal years 2003  and 2004, respectively). These data suggest that as of March 31, 2005, FDA  had received about half of the 510(k) applications that it may receive in  fiscal year 2005. Similarly, performance results for applications FDA  received in fiscal years 2003, 2004, and 2005 could change as  manufacturers respond to requests for additional information or submit  amendments to their applications. For example, as of March 31, 2005, FDA  had issued letters requesting additional information for 659 of the 510(k)  applications it received during the first 6 months of fiscal year 2005. It is  likely that FDA will receive responses to these requests from  manufacturers.
section_title: Limited Available Data Suggest That FDA is Likely to Meet Some Performance Goals Established for Fiscal Year 2006
paragraphs: 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. FDA has taken several steps to  help meet the MDUFMA performance goals.
Our analysis of FDA’s past performance shows that FDA met most, but not  all, of the MDUFMA 2006 performance goals for which it had sufficiently  complete data. (See fig. 5.) 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. Figure 5 also shows that  FDA had sufficiently complete data from both fiscal years 2003 and 2004  on 2 performance goals established for fiscal year 2006 that are tied to  510(k) applications, the type of MDUFMA-related medical device  application that FDA receives most frequently. These data indicate that  FDA met 1 of the 2 goals for applications received in both fiscal years 2003  and 2004. Sufficiently complete data were available for applications  received in fiscal years 2003 and 2004 to evaluate performance on 3 of the  2006 performance goals tied to 180-Day PMA Supplements, the type of  MDUFMA-related application that FDA receives second most frequently.  FDA met 2 of these 3 goals on applications received in both fiscal years.
Figure 5 also shows that preliminary performance data from applications  received in fiscal years 2003 and 2004 and the first 6 months of fiscal year  2005 indicate that FDA took actions tied to most of the remaining fiscal  year 2006 performance goals within specified time frames. Of 12  performance goals for which data on applications received in fiscal year  2003 were not sufficiently complete to evaluate performance, FDA had  preliminary data on 7. FDA took actions tied to 5 of these 7 goals within  the specified time frames. Of 14 performance goals for which FDA did not  have sufficiently complete data from applications received in fiscal year  2004, FDA had preliminary data for 8 and took actions tied to these 8 goals  within the specified time frames. FDA had preliminary data from  applications received in the first 6 months of fiscal year 2005 for 13 of the  26 goals established for fiscal year 2006. FDA took actions tied to these 13  goals within the established time frames. These 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.
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. There were two exceptions that involved issuing not  approvable letters as a first action on 180-Day PMA Supplements received  in fiscal year 2004 and issuing additional information letters as a first  action for 510(k)s received in fiscal year 2004. In each of these cases, FDA  met the performance goal established for fiscal year 2005, but did not meet  the goal established for fiscal year 2006.
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. For  example, FDA issued additional guidance to manufacturers on topics  related to medical device applications in fiscal year 2004 and 2005. To help  implement MDUFMA, CDRH hired 55 new staff (such as medical officers,  scientists, and engineers) in fiscal year 2004 and 44 new staff in fiscal year  2005. According to FDA, prior to the enactment of the Medical Device User  Fee Stabilization Act of 2005, there was uncertainty about the  continuation of the MDUFMA program, and as a result, most of these new  employees were hired on a temporary basis. Moreover, CDRH instituted a  hiring freeze for MDUFMA-related positions in May 2005. FDA also said  that as a consequence of hiring fewer personnel than planned to perform  tasks associated with the MDUFMA program, implementation of  improvements FDA intended to make was constrained. For example,  fewer new guidance documents were drafted, fewer existing guidance  documents were updated, and the modernization of data systems  proceeded at a slower pace than FDA intended. An FDA spokesman told  us that CDRH may lift its freeze on hiring new staff by the start of fiscal  year 2006.
section_title: Agency Comments
paragraphs: In written comments on a draft of this report, FDA concurred with our  findings. FDA also provided clarifying technical comments, which we  incorporated. FDA’s comments are reprinted in appendix I.
We are sending copies of this report to the Secretary of Health and Human  Services and the Acting Commissioner of FDA, appropriate congressional  committees, and other interested parties. We will also make copies  available to others on request. In addition, the report is available at no  charge on the GAO Web site at http://www.gao.gov. If you or your staffs  have questions about this report, please contact me at (202) 512-7119 or  crossem@gao.gov. Contact points for our Offices of Congressional  Relations and Public Affairs may be found on the last page of this report.  GAO staff who made major contributions to this report are listed in  appendix II.
section_title: Appendix I: Comments from the Food and Drug Administration
section_title: Appendix II: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Acknowledgments
paragraphs: In addition to the contact named above, James McClyde, Assistant  Director, and Kristen Joan Anderson made key contributions to this  report.