Food and Drug Administration: Limited Available Data Indicate	 
That FDA Has Been Meeting Some Goals for Review of Medical Device
Applications (30-SEP-05, GAO-05-1042).				 
                                                                 
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.							 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-05-1042					        
    ACCNO:   A38817						        
  TITLE:     Food and Drug Administration: Limited Available Data     
Indicate That FDA Has Been Meeting Some Goals for Review of	 
Medical Device Applications					 
     DATE:   09/30/2005 
  SUBJECT:   Data collection					 
	     Medical equipment					 
	     Performance measures				 
	     Program evaluation 				 
	     Reporting requirements				 
	     User fees						 
	     Performance plans					 

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GAO-05-1042

     

     *  
          * Results in Brief
          * Background
     * Types of Applications Reviewed under MDUFMA Performance Goal
     * FDA's Medical Device Application Review Processes
          * The PMA Review Process
          * The 510(k) Review Process
          * The BLA Review Process
     * Measuring FDA's Performance under MDUFMA
          * Limited Available Data Indicate That FDA Has Been Meeting So
          * Limited Available Data Suggest That FDA is Likely to Meet So
          * Agency Comments
     * Appendix I: Comments from the Food and Drug Administration
     * Appendix II: GAO Contact and Staff Acknowledgments
          * GAO Contact
          * Acknowledgments
     * Order by Mail or Phone

Report to Congressional Committees

United States Government Accountability Office

GAO

September 2005

FOOD AND DRUG ADMINISTRATION

Limited Available Data Indicate That FDA Has Been Meeting Some Goals for
Review of Medical Device Applications

FDA's Review of Device Applications FDA's Review of Device Applications
FDA's Review of Device Applications FDA's Review of Device Applications
FDA's Review of Device Applications FDA's Review of Device Applications
FDA's Review of Device Applications FDA's Review of Device Applications
FDA's Review of Device Applications FDA's Review of Device Applications
FDA's Review of Device Applications FDA's Review of Device Applications
FDA's Review of Device Applications FDA's Review of Device Applications
FDA's Review of Device Applications FDA's Review of Device Applications
FDA's Review of Device Applications FDA's Review of Device Applications
FDA's Review of Device Applications FDA's Review of Device Applications
FDA's Review of Device Applications FDA's Review of Device Applications
FDA's Review of Device Applications FDA's Review of Device Applications
FDA's Review of Device Applications FDA's Review of Device Applications
FDA's Review of Device Applications FDA's Review of Device Applications
FDA's Review of Device Applications FDA's Review of Device Applications
FDA's Review of Device Applications FDA's Review of Device Applications
FDA's Review of Device Applications

GAO-05-1042

Contents

Letter 1

Results in Brief 4
Background 6
Limited Available Data Indicate That FDA Has Been Meeting Some Performance
Goals Established for Fiscal Year 2005 16
Limited Available Data Suggest That FDA is Likely to Meet Some Performance
Goals Established for Fiscal Year 2006 22
Agency Comments 27
Appendix I Comments from the Food and Drug Administration 29
Appendix II GAO Contact and Staff Acknowledgments 30

Tables

Table 1: MDUFMA Performance Goals for Fiscal Years 2005 and 2006 14
Table 2: Applications Received in Fiscal Years 2003 and 2004 and the First
6 Months of Fiscal Year 2005 That Were Pending Further Action as of March
31, 2005 21

Figures

Figure 1: PMA Review Process 9
Figure 2: 510(k) Review Process 11
Figure 3: BLA Review Process 12
Figure 4: FDA's Performance as of March 31, 2005, for Applications
Received in Fiscal Years 2003, 2004, and 2005 as Measured against MDUFMA
Performance Goals Established for Fiscal Year 2005 18
Figure 5: FDA's Performance as of March 31, 2005, for Applications
Received in Fiscal Years 2003, 2004, and 2005 as Measured against MDUFMA
Performance Goals Established for Fiscal Year 2006 24

Abbreviations

BLA biologics license application CBER Center for Biologics Evaluation and
Research CDRH Center for Devices and Radiological Health FDA Food and Drug
Administration GMP good manufacturing practices MDUFMA Medical Device User
Fee and Modernization Act of 2002 PMA premarket approval

This is a work of the U.S. government and is not subject to copyright
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separately.

United States Government Accountability Office

Washington, DC 20548

September 30, 2005

The Honorable Mike Enzi Chairman The Honorable Edward M. Kennedy Ranking
Minority Member Committee on Health, Education, Labor and Pensions United
States Senate

The Honorable Joe Barton Chairman The Honorable John D. Dingell Ranking
Minority Member Committee on Energy and Commerce House of Representatives

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 clearance1 of applications for
marketing medical devices and licensing biological products.2 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.

1The term approval is generally used for applications for new devices,
while the term clearance is used for devices that are substantially
equivalent to those legally on the market.

2Pub. L. No. 107-250, sec. 102(a), S:S: 737 and 738, 116 Stat. 1588 (to be
codified as amended at 21 U.S.C. S:S: 379i and 379j).

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, 2004,3
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 2006.4 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).

3See GAO, Food and Drug Administration: Data to Measure the Timeliness of
Reviews of Medical Device Applications Are Limited, GAO-04-1022
(Washington, D.C.: Aug. 30, 2004).

421 U.S.C. S: 379j(g)(1)(B)(i)(II) (2000).

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.

                                Results in Brief

The available sufficiently complete 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. Our
analysis shows that FDA met most of the MDUFMA 2005 performance goals for
which there were sufficiently complete data to measure the agency's
performance. These data involve actions taken through March 31, 2005, on
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. 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 against a MDUFMA
performance goal, we reviewed preliminary data from applications received
in fiscal years 2003, 2004, and 2005. These data suggest that FDA has
taken actions tied to most of the remaining fiscal year 2005 goals within
the specified time frames. For example, FDA had preliminary data from
applications received in the first 6 months of fiscal year 2005 on 11
goals and took actions tied to these goals within the specified time
frames. 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 additional actions on applications that are pending
within the review process or as manufacturers submit additional
applications or amendments to applications.

The limited data available on FDA's performance suggest that FDA is likely
to meet some of the fiscal year 2006 performance goals. Our analysis of
FDA's past performance shows that FDA has been meeting most of the MDUFMA
2006 performance goals for which it had sufficiently complete data. 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. We also reviewed preliminary data about those goals for
which FDA did not have sufficiently complete data to evaluate performance.
FDA's preliminary data from applications received in fiscal years 2003 and
2004 and the first 6 months of fiscal year 2005 showed that FDA took
actions tied to most of the remaining fiscal year 2006 goals within
specified time frames. For example, FDA had preliminary data from
applications received in fiscal year 2005 for 13 of the 26 goals. FDA took
actions tied to these 13 goals within the established time frames. These
results are preliminary, however, and could change as FDA completes
actions tied to fiscal year 2006 goals for applications received in fiscal
years 2003, 2004, and 2005. FDA's performance could also change when FDA
starts receiving applications in fiscal year 2006.

FDA concurred with our findings.

                                   Background

Under the Federal Food, Drug, and Cosmetic Act,5 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.6 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.

Types of Applications Reviewed under MDUFMA Performance Goals

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 2006:7

           o  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).
           o  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.
           o  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.
           o  Premarket Notifications, or 510(k)s,8 are applications used
           when the intent is to market a type of device that may be
           substantially equivalent9 to a legally marketed device that was
           not subject to premarket approval.
           o  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.
           o  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.
           o  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.
           o  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.
           o  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.

           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.

           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,10 FDA multidisciplinary staff conduct a scientific
           review of the application.11 (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.12 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.

           Figure 1: PMA Review Process

           Note: This flow chart presents the typical review process for
           applications for which FDA has conducted an initial screening and
           determined that the review should proceed.

           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.

           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.

           Figure 2: 510(k) Review Process

           Note: This flow chart presents the typical review process to
           determine whether a 510(k) application is required and, if so,
           whether a device is substantially equivalent to a legally marketed
           device that was not subject to premarket approval.

           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.

           Figure 3: BLA Review Process

           Note: This flow chart presents the typical review process for
           BLA-related applications for which FDA has conducted an initial
           screening and determined that the review should proceed.

           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.13

           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,14 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.

5Ch. 675, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. S:S: 301
et seq. (2000)).

6In general, an application to market a medical device includes
information on the device and its components; proposed labeling for the
device; and when applicable, clinical and nonclinical studies that provide
reasonable assurance of the device's safety and effectiveness.

7Some types of applications that involve biologics licenses are linked to
MDUFMA performance goals established for 2006, but not for 2005.

8FDA refers to a premarket notification submission as a 510(k) because the
requirement for them is set out in section 510(k) of the Federal Food,
Drug, and Cosmetic Act. 42 U.S.C. S: 360(k) (2000).

9Substantial equivalence means that a device has (1) the same intended use
and same technological characteristics as a marketed device or (2) the
same intended use and different technological characteristics, but is as
safe and effective as the marketed device and does not raise new questions
of safety and effectiveness.

FDA's Medical Device Application Review Processes

  The PMA Review Process

10This initial screening is called a filing review.

11The scientific review can include reviews of results from clinical
investigations of the device that involve human subjects. FDA also reviews
nonclinical studies of the device, and studies that may include
microbiological, toxicological, and engineering tests.

12For example, approximately 22 percent of PMAs and Expedited PMAs were
referred to external advisory committees in fiscal years 2002 and 2003.
The percentage in fiscal year 2004 was closer to 40 percent. FDA does not
refer 180-Day PMA Supplements to external advisory committees.

  The 510(k) Review Process

  The BLA Review Process

Measuring FDA's Performance under MDUFMA

13If a manufacturer submits an amendment that contains substantial new
information while FDA is reviewing a PMA, Expedited PMA, Premarket Report,
Panel-Track Supplement, or 180-Day PMA Supplement without having received
a request for additional information from FDA, the time period allowed for
the review is extended. There are limits on the length of time
manufacturers have to respond to certain letters indicating that FDA needs
additional information to reach a decision about a device. For example, as
required by FDA regulation, manufacturers who have submitted PMAs have 180
days to submit amendments in response to major deficiency letters.
Manufacturers submitting amendments to PMAs can also apply for extensions
of up to 180 days beyond the required response time. Manufacturers who
have submitted 510(k)s have 30 days to respond to first or subsequent
letters requesting additional information and can apply for extensions of
up to 180 days from the date of the first or subsequent letters.

14FDA refers to cohorts as "receipt cohorts."

Table 1: MDUFMA Performance Goals for Fiscal Years 2005 and 2006

                                      Performance 
                                         goal     
                                                  Percentage of Percentage of 
                                                  actions taken actions taken 
                                                             on            on 
                                                   applications  applications 
                                                    received in   received in 
                                                    fiscal year   fiscal year 
                                                    2005 cohort   2006 cohort 
                   FDA actions,                     required to   required to 
Type of         including                        meet review   meet review 
application     decisions          Review time          time          time 
PMAs,           Issue a decision      320 days           Not            80 
Panel-Track     letterb                           applicable 
Supplements,    Issue a first         150 days            75            80 
and Premarket   major deficiency                             
Reportsa        letter                                       
                   Issue a decision      180 days            75            80 
                   letter as a first                            
                   action on an                                 
                   applicationb                                 
                   Issue a second or     120 days            75            80 
                   subsequent major                             
                   deficiency letter                            
                   Act on an             180 days            75            80 
                   amendment                                    
                   containing a                                 
                   complete response                            
                   to a major                                   
                   deficiency or not                            
                   approvable letter                            
                   Act on an              30 days            90            90 
                   amendment                                    
                   containing a                                 
                   complete response                            
                   to an approvable                             
                   letter pending                               
                   minor corrections                            
                   or clarifications                            
Expedited PMAs  Issue a decision      300 days            70            80 
                   letterb                                      
                   Issue a first         120 days            70            80 
                   major deficiency                             
                   letter                                       
                   Issue a decision      170 days            70            80 
                   letter as a first                            
                   action on an                                 
                   applicationb                                 
                   Issue a second or     100 days            70            80 
                   subsequent major                             
                   deficiency letter                            
                   Act on an             170 days            70            80 
                   amendment                                    
                   containing a                                 
                   complete response                            
                   to a major                                   
                   deficiency or not                            
                   approvable letter                            
                   Act on an              30 days            90            90 
                   amendment                                    
                   containing a                                 
                   complete response                            
                   to an approvable                             
                   letter pending                               
                   minor corrections                            
                   or clarifications                            
180-Day PMA     Issue a decision      180 days            80            80 
Supplements     letterb                                      
                   Issue a not           120 days            80            85 
                   approvable letter                            
                   as a first action                            
                   on an application                            
                   Issue a decision      180 days            80            85 
                   letter other than                            
                   a not approvable                             
                   letter as a first                            
                   action on an                                 
                   applicationb                                 
                   Act on an             160 days            80            85 
                   amendment                                    
                   containing a                                 
                   complete response                            
                   to a not                                     
                   approvable letter                            
510(k)s         Issue a decision       90 days            75            75 
                   letterc                                      
                   Issue a first          75 days            70            80 
                   additional                                   
                   information letter                           
                   Issue a second or      60 days            70            80 
                   subsequent                                   
                   additional                                   
                   information letter                           
BLAs            Review and act on    10 months           Not            75 
                   a standard                        applicable 
                   original BLA                                 
                   Review and act on     6 months           Not            75 
                   a priority                        applicable 
                   original BLA                                 
BLA Supplements Review and act on    10 months           Not            75 
                   a standard BLA                    applicable 
                   efficacy                                     
                   supplement                                   
                   Review and act on     6 months           Not            75 
                   a priority BLA                    applicable 
                   efficacy                                     
                   supplement                                   
                   Review and act on     4 months           Not            75 
                   a BLA                             applicable 
                   manufacturing                                
                   supplement that                              
                   requires prior                               
                   approval                                     
BLA             Review and act on     2 months            75            80 
Resubmissions   a Class 1                                    
and BLA         resubmission to an                           
Efficacy        original BLA or                              
Supplement      BLA efficacy                                 
Resubmissions   supplement                                   
                   Review and act on     6 months            75            80 
                   a Class 2                                    
                   resubmission to an                           
                   original BLA or                              
                   BLA efficacy                                 
                   supplement                                   

Source: GAO analysis of FDA data.

aFDA groups these types of applications when measuring performance for
this goal.

bA decision letter for a PMA, Panel-Track Supplement, Premarket Report,
Expedited PMA, or 180-Day PMA Supplement can indicate approval, approvable
pending GMP inspection, approvable pending minor corrections or
clarifications, not approvable, or denial. MDUFMA performance goals linked
to issuance of a decision letter for these applications include a
performance goal that is linked to issuance of a decision letter as a
first action on an application and a performance goal that is linked to
issuance of a decision letter regardless of whether that letter is issued
as a first or later action.

cA decision letter for a 510(k) can indicate that the device may be
marketed because it is substantially equivalent to one already on the
market or may not be marketed because it is not substantially equivalent.

Limited Available Data Indicate That FDA Has Been Meeting Some Performance Goals
                        Established for Fiscal Year 2005

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.

Figure 4: FDA's Performance as of March 31, 2005, for Applications
Received in Fiscal Years 2003, 2004, and 2005 as Measured against MDUFMA
Performance Goals Established for Fiscal Year 2005

Note: FDA's data for some MDUFMA performance goals are not complete
because applications are 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. In contrast, when FDA's data were not sufficiently
complete to evaluate performance, we considered data on FDA's performance
to be preliminary. The performance goals established for fiscal year 2005
did not include any goals tied to BLAs or BLA Supplements.

aFDA groups these types of applications when measuring performance for
this goal. FDA did not receive any Premarket Reports in fiscal years 2003
or 2004 or the first 6 months of fiscal year 2005.

bA decision letter for a PMA, Panel-Track Supplement, Premarket Report,
Expedited PMA, or 180-Day PMA Supplement can indicate approval, approvable
pending GMP inspection, approvable pending minor corrections or
clarifications, not approvable, or denial.

cAs of March 31, 2005, FDA had not received any submissions that required
the agency to take the action tied to the performance goal. It could
subsequently receive submissions.

dThis performance goal had also been established for fiscal years 2003 and
2004 and required 90 percent of actions to be taken within 30 days.

eA decision letter for a 510(k) can indicate that the device may be
marketed because it is substantially equivalent to one already on the
market or may not be marketed because it is not substantially equivalent.

fFDA did not receive any submissions that required the agency to take the
action tied to the performance goal. No additional submissions are
possible.

gAs of March 31, 2005, FDA had received submissions tied to the
performance goal, but had not taken any actions tied to the goal. FDA
could subsequently receive additional submissions.

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.15 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.

15FDA did not have data on a performance goal if the agency had not
received any applications of the type that is tied to that goal or if the
agency had received applications of that type but had not taken any of the
actions tied to the goal as of March 31, 2005.

Table 2: Applications Received in Fiscal Years 2003 and 2004 and the First
6 Months of Fiscal Year 2005 That Were Pending Further Action as of March
31, 2005

                                                                                          First 6 months
                                                                                          of fiscal year
                         Fiscal year 2003                      Fiscal year 2004                2005
              Total number       Number      Total number       Number      Total number           Number
Type of                 of (percentage)                of (percentage)                of     (percentage)
application   applications      pending      applications      pending      applications          pending
PMA and                                                                                                   
Panel-Track                                                                                    
Supplements                          50     5(10.0%)                48     13(27.1%)        23  22(95.7%)
Expedited                                                                                                 
PMAs                                  3      0(0.0%)                14      6(42.9%)         3   2(66.7%)
180-Day PMA                                                                                               
Supplements                         206      0(0.0%)               106       0(0.0%)        45  27(60.0%)
510(k)s                           3,805     15(0.4%)             3,432     165(4.8%)     1,703 770(45.2%) 
BLAs                                  0      0(0.0%)                 9      1(11.1%)         1  1(100.0%) 
BLA                                                                                                       
Supplements                          78      0(0.0%)                96       0(0.0%)        12   4(33.3%)
BLA                                                                                                       
Resubmissions                                                                                  
and BLA                                                                                        
Efficacy                                                                                       
Supplement                                                                                     
Resubmissions                         2      0(0.0%)                 5       0(0.0%)         5    5(100%)
Total                             4,144     20(0.5%)             3,710     185(5.0%)     1,792 831(46.4%) 

Source: GAO analysis of FDA data.

Note: FDA did not receive any Premarket Reports in fiscal years 2003 or
2004 or in the first 6 months of fiscal year 2005.

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.

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. 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: FDA's Performance as of March 31, 2005, for Applications
Received in Fiscal Years 2003, 2004, and 2005 as Measured against MDUFMA
Performance Goals Established for Fiscal Year 2006

Note: FDA's data for some MDUFMA performance goals are not complete
because applications are 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. In contrast, when FDA's data were not sufficiently
complete to evaluate performance, we considered data on FDA's performance
to be preliminary.

aFDA groups these types of applications when measuring performance for
this goal. FDA did not receive any Premarket Reports in fiscal years 2003
or 2004 or the first 6 months of fiscal year 2005.

bA decision letter for a PMA, Panel-Track Supplement, Premarket Report,
Expedited PMA, or 180-Day PMA Supplement can indicate approval, approvable
pending GMP inspection, approvable pending minor corrections or
clarifications, not approvable, or denial.

cAs of March 31, 2005, FDA had not received any submissions that required
the agency to take the action tied to the performance goal. It could
subsequently receive submissions.

dA decision letter for a 510(k) can indicate that the device may be
marketed because it is substantially equivalent to one already on the
market or may not be marketed because it is not substantially equivalent.

eFDA did not receive any submissions that required the agency to take the
action tied to the performance goal. No additional submissions are
possible.

fAs of March 31, 2005, FDA had received submissions tied to the
performance goal, but had not taken any actions tied to the goal. FDA
could subsequently receive additional submissions.

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 2005,16 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.

                                Agency Comments

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
[email protected]. 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.

16Pub. L. No. 109-43, S: 2(a)(5), 119 Stat. 439, 440.

Marcia Crosse Director, Health Care

Appendix I: Comments from the Food and Drug Administration Appendix I:
Comments from the Food and Drug Administration

Ap Ac Appendix II: GAO Contact and Staff Acknowledgments

                                  GAO Contact

Marcia Crosse, (202) 512-7119 or [email protected]

                                Acknowledgments

In addition to the contact named above, James McClyde, Assistant Director,
and Kristen Joan Anderson made key contributions to this report.

(290452)

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Highlights of GAO-05-1042 , a report to congressional committees

September 2005

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.

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.
*** End of document. ***