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Report to Congressional Committees: 

August 2004: 

Food and Drug Administration: 

Data to Measure the Timeliness of Reviews of Medical Device 
Applications Are Limited: 

[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-04-1022]: 

GAO Highlights: 

Highlights of GAO-04-1022, a report to congressional committees

Why GAO Did This Study: 

FDA reviews applications from manufacturers that wish to market medical 
devices in the United States. To ensure prompt approval of new devices 
and clearance of devices that are substantially equivalent to those 
legally on the market, the Congress passed the Medical Device User Fee 
and Modernization Act of 2002 (MDUFMA). The act authorizes FDA to 
collect user fees and, in return, requires FDA to meet performance 
goals that are tied to the agency’s review process. The goals set 
actions FDA may take on applications and specify the time that FDA 
should take in certain phases of the review process. 

MDUFMA requires GAO to report on FDA’s performance against the MDUFMA 
performance goals established for fiscal years 2003 and 2004 and to 
determine whether FDA is likely to meet the fiscal year 2005 
performance goals. MDUFMA also requires GAO to report on the amounts 
FDA obligated in fiscal year 2002 for medical device compliance 
activities and inspections of manufacturers after their devices are 
marketed.

GAO analyzed data provided by FDA that are based on actions taken on 
applications FDA received from October 1, 2002, through March 31, 2004. 
GAO also analyzed data on the amounts FDA obligated for medical device 
compliance and inspection activities for fiscal year 2002. 

What GAO Found: 

FDA had limited data that could be used to measure the agency’s 
performance against most of the MDUFMA performance goals. Thus, it is 
uncertain whether FDA will meet the MDUFMA performance goals for fiscal 
years 2003, 2004, and 2005. For fiscal years 2003 and 2004, there were 
two performance goals in effect for each year. As of March 31, 2004, 
only one application was subject to the action tied to one of the two 
MDUFMA performance goals. On this application, FDA completed its review 
and made the decision to approve the application within the goal’s 
established time frame. To determine the likelihood of meeting the 20 
MDUFMA performance goals for fiscal year 2005, FDA is collecting data 
on its performance against these goals. GAO found that FDA had 
performance data for some, but not all, of the MDUFMA performance 
goals. From fiscal year 2003 applications, data were available to 
compare FDA’s performance against 17 of the 20 fiscal year 2005 
performance goals. FDA took actions tied to 14 of the 17 goals within 
the goals’ established time frames. From fiscal year 2004 applications, 
data were available to compare FDA’s performance against 11 of the 20 
performance goals. FDA took actions tied to the 11 goals within the 
goals’ established time frames. The results of FDA’s performance 
against MDUFMA performance goals are preliminary, however, because 8 
percent and 49 percent, respectively, of the applications FDA accepted 
in fiscal year 2003 and the first 6 months of fiscal year 2004 were 
awaiting action by FDA or responses from manufacturers. Because FDA’s 
performance against the MDUFMA performance goals is based on the 
percentages of actions the agency takes within required review times, 
FDA’s results could change as the agency completes its actions on all 
applications for which the goals apply.

FDA obligated about $128 million for postmarket medical device 
compliance activities and inspections in fiscal year 2002. FDA 
obligated about $109 million for compliance activities for outreach 
coordination, such as guidance to field staff on reporting problems 
with medical devices, laboratory analyses, and research, such as the 
development of domestic and international standards to provide 
reasonable assurance that medical device products are safe and 
effective. FDA obligated about $19 million for inspections of device 
manufacturers’ establishments, including routine surveillance 
inspections to determine compliance with medical device regulations 
and inspections resulting from device problem reporting or product 
recalls.

In commenting on a draft of this report, FDA generally agreed with its 
findings.

www.gao.gov/cgi-bin/getrpt?GAO-04-1022.

To view the full product, including the scope and methodology, click 
on the link above. For more information, contact Marcia Crosse at 
(202) 512-7119.

[End of section]

Contents: 

Letter: 

Results in Brief: 

Background: 

Limited Data to Measure FDA's Performance against the MDUFMA 
Performance Goals: 

FDA Obligated over $128 Million for Postmarket Medical Device 
Compliance Activities and Inspections in Fiscal Year 2002: 

Agency Comments: 

Appendix: 

Appendix I: Comments from the Food and Drug Administration: 

Tables: 

Table 1: MDUFMA Performance Goals for Fiscal Years 2003 and 2004: 

Table 2: MDUFMA Performance Goals for Fiscal Year 2005: 

Table 3: Status of FDA's Performance for Fiscal Years 2003 and 2004 
Compared to MDUFMA Performance Goals That Become Effective in Fiscal 
Year 2005: 

Table 4: Applications Pending within FDA's Review Process in the Fiscal 
Year 2003 Cohort and the First 6 Months of the Fiscal Year 2004 Cohort: 

Figures: 
 
Figure 1: PMA Review Process: 

Figure 2: 510(k) Review Process: 

Abbreviations: 

BLA: biologics license application: 

CBER: Center for Biologics Evaluation and Research: 

CDRH: Center for Devices and Radiological Health: 

FDA: Food and Drug Administration: 

FDCA: Federal Food, Drug, and Cosmetics Act: 

GMP: good manufacturing practices: 

HHS: Department of Health and Human Services: 

MDUFMA: Medical Device User Fee and Modernization Act of 2002: 

PMA: premarket approval: 

Letter August 30, 2004: 

The Honorable Judd Gregg: 
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 of their safety and 
effectiveness for human use. As part of its regulatory 
responsibilities, FDA reviews applications from manufacturers that wish 
to have their new medical devices or devices substantially equivalent 
to those already on the market approved for marketing in the United 
States. When required, FDA inspects manufacturers' establishments prior 
to approval. FDA is also responsible for implementing and enforcing 
medical device regulations related to compliance activities, which 
include the reporting of problems associated with the safety and 
effectiveness of devices and inspections of manufacturers' device 
establishments after devices reach the market.

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 about the length of 
time it takes FDA to review applications for marketing medical devices, 
with the consequence of possibly delaying 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[Footnote 1] of 
applications for marketing medical devices and licensing biological 
products.[Footnote 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 process for medical device and 
biological applications. MDUFMA also requires the Secretary of Health 
and Human Services (HHS) to develop the specific goals FDA must meet. 
The Secretary developed performance goals for fiscal years 2003 through 
2007. These MDUFMA performance goals are set for certain actions FDA 
may take during the application review process and specify lengths of 
time for taking these actions. FDA's performance against the MDUFMA 
performance goals is based on the percentages of actions the agency 
takes on applications within required review times. To help FDA meet 
the MDUFMA performance goals, the Secretary of HHS also identified 
several goal-related activities for FDA to undertake, such as hiring 
additional review staff.

The number of MDUFMA performance goals that FDA must meet increases 
over time. For fiscal years 2003 and 2004, FDA must meet the same two 
performance goals for each year. For example, one of the performance 
goals requires FDA to review a manufacturer's response to the agency's 
request for additional information on applications that are approvable 
with minor corrections or clarifications,[Footnote 3] and then take the 
next appropriate action, such as make a decision to approve the 
application. To meet the performance goal, FDA must review and make the 
decision within 30 days on 90 percent of the applications received for 
each fiscal year. In fiscal year 2005, FDA must meet the two goals and 
an additional 18 performance goals tied to medical device and 
biological product applications, for a total of 20. The 20 performance 
goals are tied to times for reviews, decisions, or a combination of 
both.

MDUFMA requires us to report on FDA's performance as measured against 
the fiscal years 2003 and 2004 MDUFMA performance goals and determine 
whether the agency is likely to meet the fiscal year 2005 MDUFMA 
performance goals. MDUFMA also requires us to report on the amounts FDA 
obligated in fiscal year 2002 for medical device compliance activities 
and inspections of manufacturers' device establishments after their 
devices are marketed, excluding the amounts that were obligated for 
inspections related to the review of medical device applications.

To examine FDA's performance, we analyzed actions taken by FDA on 
applications that it received from fiscal year 2003 through the first 6 
months of fiscal year 2004 (October 1, 2003, through March 31, 2004). 
At the time of our review, performance data through March 31, 2004, 
were the most current FDA data available. To assess FDA's performance 
against the two MDUFMA performance goals that were established for 
fiscal years 2003 and 2004, we analyzed performance data for 
applications received in those years. To determine the likelihood of 
FDA meeting its fiscal year 2005 MDUFMA performance goals, we compared 
performance data that FDA is collecting on fiscal years 2003 and 2004 
applications to the 20 MDUFMA performance goals that will be effective 
in fiscal year 2005. We also reviewed relevant documents and 
interviewed officials from FDA's Center for Devices and Radiological 
Health (CDRH) and Center for Biologics Evaluation and Research (CBER) 
about two key FDA medical device application review processes and the 
agency's performance as measured against the MDUFMA performance goals. 
These two processes are referred to as (1) the Premarket Approval (PMA) 
review process, which is used to review an application for a new 
medical device or when the risks associated with the device are 
considerable, and (2) the 510(k) review process, which is used to 
review an application for a type of device that may be substantially 
equivalent to one already on the market. In addition, we reviewed 
documentation of FDA's procedures for checking the reliability of 
MDUFMA performance data and met with FDA officials to discuss their 
efforts to verify the accuracy and consistency of their reported 
performance data. We determined that the performance data were 
sufficiently reliable for the purposes of this report.

To determine the amounts FDA obligated in fiscal year 2002 for medical 
device compliance activities and inspections of manufacturers' device 
establishments after devices are marketed, we reviewed and analyzed 
data from FDA's fiscal year 2004 budget justification and information 
FDA provided related to these data. The fiscal year 2004 budget 
justification contains FDA's fiscal year 2002 actual obligations for 
medical device compliance activities and inspections. To assess the 
reliability of these data, we reviewed supporting documentation that 
FDA provided on the obligations reported in the agency's fiscal year 
2004 budget justification related to compliance activities and 
inspections for marketed devices. We also reviewed FDA's fiscal year 
2003 audited financial statement report that contained information 
about the reliability of fiscal year 2002 obligations data. The review 
found no material weaknesses related to our work. Based on these 
reviews, we determined that the obligations data were sufficiently 
reliable for the purposes of this report. We conducted our work from 
January 2004 through August 2004 in accordance with generally accepted 
government auditing standards.

Results in Brief: 

FDA had limited data that could be used to measure the agency's 
performance against most of the MDUFMA performance goals. Thus, it is 
uncertain whether FDA will meet the goals established for fiscal years 
2003, 2004, and 2005. For example, for fiscal year 2003, the two 
performance goals could be applied to 53 applications. However, as of 
March 31, 2004, only one application was subject to a review and a 
decision tied to one of the two MDUFMA performance goals. On that 
application, FDA reviewed the manufacturer's complete response to FDA's 
approvable letter and made the decision to approve the application 
within the goal's established time frame. For fiscal year 2004, there 
was no application subject to the review and decision tied to the two 
fiscal year 2004 MDUFMA performance goals. FDA had performance data for 
some, but not all, of the MDUFMA performance goals that will be 
effective in fiscal year 2005. For applications received in fiscal year 
2003, data were available to compare FDA's performance against 17 of 
the 20 performance goals for fiscal year 2005. FDA took actions on 
applications tied to 14 of the 17 performance goals within the 
established time frames. For fiscal year 2004 applications, FDA had 
performance data for 11 of the 20 performance goals. FDA took actions 
on applications tied to the 11 goals within the established time 
frames. The results of FDA's performance against MDUFMA goals are 
preliminary, however, because many of the applications FDA received in 
fiscal year 2003 and the first 6 months of fiscal year 2004 were 
pending within the review process. Because FDA's performance against 
the MDUFMA performance goals is based on the percentages of actions the 
agency takes on applications within required review times, FDA's 
performance results could change as the agency completes actions on all 
applications for which the performance goals apply.

FDA obligated over $128 million for postmarket medical device 
compliance activities and inspections in fiscal year 2002. FDA 
obligated about $109 million for compliance activities for outreach 
coordination, such as guidance to field staff on the reporting of 
problems with medical devices; laboratory analyses; and research, such 
as the development of domestic and international standards to help 
provide reasonable assurance that medical devices are safe and 
effective. FDA obligated about $19 million for inspections of 
manufacturers' device establishments that included routine surveillance 
inspections to determine compliance with medical device regulations and 
inspections resulting from device problem reporting or product recalls.

We provided a draft of this report to FDA, which generally agreed with 
its findings. FDA believes that it has made a good start in its 
implementation of MDUFMA and believes its progress with the MDUFMA 
performance goals is consistent with the extensive performance 
improvements the agency is expected to achieve each year through 2007.

Background: 

Under the Federal Food, Drug, and Cosmetic Act (FDCA),[Footnote 4] 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 the PMA and clearance of medical device 
applications.[Footnote 5] CDRH reviews applications for the majority of 
devices marketed, such as artificial hearts, dialysis machines, and 
radiological devices. CBER reviews applications for devices used in the 
testing and manufacture of biological products, such as diagnostic 
tests intended to screen blood donors (such as for the human 
immunodeficiency virus), as well as devices used in cell and gene 
therapies.

Each fiscal year, FDA obligates funds for postmarket compliance 
activities and inspections related to medical devices and radiological 
products. FDA provides field staff with guidance on inspecting 
manufacturers' establishments after devices have been marketed, for 
compliance with the good manufacturing practices (GMP) requirements, 
monitoring manufacturers' corrections of problems with devices, and 
removing unsafe devices from the market. FDA has 21 district offices 
that support inspections of manufacturers' establishments. During 
inspections for compliance with GMP requirements, FDA investigators 
examine manufacturer facilities, records of manufacturing processes, 
and corrective action programs.

Types of Applications Reviewed under MDUFMA Performance Goals: 

MDUFMA identified eight types of applications for medical devices and 
biological products that are subject to the performance goals developed 
by the Secretary of HHS for fiscal years 2003, 2004, and 2005: 

* Original 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 implanted in the body for life-
supporting purposes).

* Premarket Notifications, or 510(k)s,[Footnote 6] are applications 
used when the intent is to market a type of device that may be 
considered substantially equivalent[Footnote 7] to one already on the 
market and therefore, does not require PMA.

* Premarket Reports are applications required for high-risk devices 
originally approved for a single use that a manufacturer has 
reprocessed for additional uses.

* 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 the device.

* Expedited Original PMAs are used when a manufacturer seeks priority 
status to market a medical device that is intended to treat or diagnose 
a life-threatening or irreversibly debilitating disease or condition or 
to address an unmet medical need.

* The 180-day PMA Supplements are used to supplement approved PMAs or 
premarket reports. The application typically requests approval of a 
significant change in aspects of a device, such as its design, 
specifications, or labeling.

* Biologics license applications (BLAs)[Footnote 8] Resubmissions 
(Class 1) are used to respond to information requested by FDA on a BLA 
and may include matters related to product labeling or safety and other 
minor clarifying information. BLA Supplement Resubmissions (Class 2) 
are used to respond to an FDA request for information on a BLA 
regarding the safety and effectiveness of products or a re-inspection 
of the manufacturer's device establishment.

FDA's Medical Device Application Review Processes: 

FDA primarily uses two medical device application review processes; the 
PMA review process and the 510(k) review process.[Footnote 9] FDA 
annually receives about 50 PMAs and about 4,000 510(k) applications for 
review through these processes.

The PMA 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, 
Premarket Reports, Panel-Track Supplements, Expedited Original PMAs, 
and 180-day PMA Supplements. After an initial screening of an 
application and determination that the review should proceed, an FDA 
multidisciplinary staff conducts a scientific review of the 
application[Footnote 10] and determines whether it is complete, that 
is, if it contains sufficient information to allow the review to 
continue. (See fig. 1.): 

Figure 1: PMA Review Process: 

[See PDF for image]

[End of figure]

For complete applications, 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 finds that the 
manufacturer's device establishment is in compliance with GMP 
requirements; (3) send the manufacturer an approvable letter indicating 
that the agency should be able to approve the device if the 
manufacturer can make minor corrections or clarifications to the 
application; (4) issue a "not approvable" letter informing the 
manufacturer that FDA does not believe that the application can be 
approved because the data provided by the manufacturer do not 
demonstrate that the device is reasonably safe and effective; or (5) 
issue an order denying approval of the application, which informs the 
manufacturer that the agency has completed its scientific review, 
identified major safety and effectiveness problems, and decided not to 
approve the application. FDA may refer complete applications to an 
external advisory committee for evaluation 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.[Footnote 11] For applications 
referred to an advisory committee, the committee submits 
recommendations to FDA on the safety and effectiveness of the devices. 
Taking the committee's recommendations into consideration, FDA then 
makes its decision.

For incomplete applications, that is, applications for which FDA 
determines it needs significant additional information, FDA issues a 
"major deficiency letter" to the manufacturer identifying the 
information that is required to provide reasonable assurance of the 
safety and effectiveness of the device. This request for significant 
information is an action referred to as a cycle action. In general, FDA 
takes cycle actions when it requests additional information from the 
manufacturer, or when it evaluates additional information provided by 
the manufacturer in response to an FDA request. The manufacturer 
responds to FDA's request by submitting an amendment to the original 
application. Cycle actions on an application can occur repeatedly until 
FDA determines that the manufacturer has provided what the agency calls 
a "complete response" to all of the agency's concerns. Then, FDA may 
make a decision on the application.

Manufacturers that receive approvable letters pending minor corrections 
or clarifications or not approvable letters can gain final approval by 
submitting amendments with complete responses to FDA's concerns. For 
both types of decisions, if FDA, as part of a cycle action, determines 
that the manufacturer's amendment is a complete response, FDA issues an 
order approving the application. If the amendment is not a complete 
response, FDA issues another approvable letter pending minor 
corrections or clarifications or a not approvable letter.

The 510(k) Review Process: 

Under the 510(k) review process, FDA decides whether the application 
contains sufficient information to determine whether the device is 
substantially equivalent to one legally on the market (see fig. 2). 
When a 510(k) application lacks information necessary for FDA to 
complete its review and make a determination as to whether the device 
is substantially equivalent, the agency issues a letter requesting 
additional information from the manufacturer. This request for 
additional information is a cycle action. The manufacturer may then 
submit additional information responding to FDA's concerns. Once FDA 
has obtained complete information from the manufacturer, FDA issues a 
decision letter informing the manufacturer that the device is 
substantially equivalent and therefore may be marketed or the device is 
not substantially equivalent and may not be marketed.

Figure 2: 510(k) Review Process: 

[See PDF for image]

[End of figure]

Measuring FDA's Performance under MDUFMA: 

The MDUFMA performance goals specify a length of time for taking a 
cycle action, making a decision, or a combination of both. The goals 
designate a certain percentage of these actions that must occur within 
the specified period in order for FDA to meet the performance goals. To 
measure its performance against the MDUFMA performance goals, FDA 
tracks the time, in calendar days, the agency takes to complete a cycle 
action or make a decision--but not the time it takes a manufacturer to 
respond to a request from FDA.[Footnote 12]

FDA measures its performance against a specific fiscal year's MDUFMA 
performance goals using all the applications it received in that year-
-known as a cohort[Footnote 13]--regardless of when the final decision 
is made for each of the applications in that year's cohort.The agency's 
performance as measured against a fiscal year's MDUFMA performance 
goals is preliminary until all applications in a cohort are completed -
-and this can take up to 3 or 4 fiscal years.

The two MDUFMA performance goals that FDA must meet for fiscal years 
2003 and 2004 are tied to the same type of cycle action for different 
types of applications. One performance goal applies to the cycle action 
taken on PMAs, Panel-Track Supplements, and Premarket Reports, and the 
other performance goal applies to Expedited PMAs. To meet each 
performance goal, FDA must review the completeness of a manufacturer's 
response to an approvable letter pending minor corrections or 
clarifications and make a decision within 30 days of receiving the 
manufacturer's amendment. FDA must meet this time frame on 90 percent 
of the applications for which it takes a cycle action (see table 1).

Table 1: MDUFMA Performance Goals for Fiscal Years 2003 and 2004: 

Type of application: PMAs, Panel-Track Supplements, and Premarket 
Reports[A]; 
FDA cycle actions: Review whether an amendment is a complete response 
to an approvable letter pending minor corrections or clarifications and 
make a decision, such as approving the application; 
Performance goal: Review time: 30 days; 
Performance goal: Percentage of applications received in each fiscal 
year required to meet review time: Fiscal year 2003 cohort: 90%; 
Performance goal: Percentage of applications received in each fiscal 
year required to meet review time: Fiscal year 2004 cohort: 90%. 

Type of application: Expedited PMAs; 
FDA cycle actions: Review whether an amendment is a complete response 
to an approvable letter pending minor corrections or clarifications and 
make a decision, such as approving the application; 
Performance goal: Review time: 30 days; 
Performance goal: Percentage of applications received in each fiscal 
year required to meet review time: Fiscal year 2003 cohort: 90%; 
Performance goal: Percentage of applications received in each fiscal 
year required to meet review time: Fiscal year 2004 cohort: 90%. 

Source: GAO analysis of HHS and FDA information.

[A] FDA groups these types of applications together when measuring 
performance for this goal.

[End of table]

In fiscal year 2005, 20 MDUFMA performance goals will become effective, 
including the 2 performance goals that have been effective since fiscal 
year 2003 (see table 2). The 20 performance goals will apply to eight 
types of applications identified under MDUFMA and will be tied to other 
cycle actions and decisions FDA makes on the applications during the 
review process.

Table 2: MDUFMA Performance Goals for Fiscal Year 2005: 

Type of application: PMAs, Panel-Track Supplements, and Premarket 
Reports[A]; 
FDA cycle actions and decisions: Cycle action: Issue first major 
deficiency letter requesting significant information from the 
manufacturer; 
Performance goal: Review time: 150 days; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 75%. 

Type of application: PMAs, Panel-Track Supplements, and Premarket 
Reports[A]; 
FDA cycle actions and decisions: Decision: Issue decision letter 
(approval, approvable pending GMP inspection, approvable pending minor 
corrections or clarifications, not approvable, or denial) as a first 
action on an application; 
Performance goal: Review time: 180 days; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 75%. 

Type of application: PMAs, Panel-Track Supplements, and Premarket 
Reports[A]; 
FDA cycle actions and decisions: Cycle action: Issue second or 
subsequent major deficiency letter requesting significant information 
from the manufacturer; 
Performance goal: Review time: 120 days; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 75%. 

Type of application: PMAs, Panel-Track Supplements, and Premarket 
Reports[A]; 
FDA cycle actions and decisions: Cycle action: Determine whether an 
amendment contains a complete response to a major deficiency or not 
approvable letter; 
Performance goal: Review time: 180 days; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 75%. 

Type of application: PMAs, Panel-Track Supplements, and Premarket 
Reports[A]; 
FDA cycle actions and decisions: Cycle action: Review whether an 
amendment contains a complete response to an approvable letter pending 
minor corrections or clarifications and make a decision, such as 
approving the application; 
Performance goal: Review time: 30 days; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 90%. 

Type of application: Expedited PMAs; 
FDA cycle actions and decisions: Decision: Issue decision letter 
(approval, approvable pending GMP inspection, approvable pending minor 
corrections or clarifications, not approvable, or denial) after taking 
a cycle action on an application; 
Performance goal: Review time: 300 days; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 70%. 

Type of application: Expedited PMAs; 
FDA cycle actions and decisions: Cycle action: Issue first major 
deficiency letter requesting significant information from the 
manufacturer; 
Performance goal: Review time: 120 days; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 70%. 

Type of application: Expedited PMAs; 
FDA cycle actions and decisions: Decision: Issue decision letter 
(approval, approvable pending GMP inspection, not approvable, 
approvable pending minor corrections or clarifications, or denial) as 
a first action on an application; 
Performance goal: Review time: 170 days; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 70%. 

Type of application: Expedited PMAs; 
FDA cycle actions and decisions: Cycle action: Issue a second or 
subsequent major deficiency letter requesting significant information 
from the manufacturer; 
Performance goal: Review time: 100 days; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 70%. 

Type of application: Expedited PMAs; 
FDA cycle actions and decisions: Cycle action: Determine whether an 
amendment contains a complete response to a major deficiency or not 
approvable letter; 
Performance goal: Review time: 170 days; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 70%. 

Type of application: Expedited PMAs; 
FDA cycle actions and decisions: Cycle action: Review whether an 
amendment contains a complete response to an approvable letter pending 
minor corrections or clarifications and make a decision, such as 
approving the application; 
Performance goal: Review time: 30 days; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 90%. 

Type of application: 180-day PMA Supplements; 
FDA cycle actions and decisions: Decision: Issue decision letter 
(approval, approvable pending GMP inspection, approvable pending minor 
corrections or clarifications, not approvable, or denial) after taking 
a cycle action on an application; 
Performance goal: Review time: 180 days; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 80%. 

Type of application: 180-day PMA Supplements; 
FDA cycle actions and decisions: Decision: Issue a not approvable 
letter as a first action on an application; 
Performance goal: Review time: 120 days; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 80%. 

Type of application: 180-day PMA Supplements; 
FDA cycle actions and decisions: Decision: Issue decision letter 
(approval, approvable pending GMP inspection, approvable pending minor 
corrections or clarifications, or denial) as a first action on an 
application; 
Performance goal: Review time: 180 days; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 80%. 

Type of application: 180-day PMA Supplements; 
FDA cycle actions and decisions: Cycle action: Determine whether an 
amendment contains a complete response to a not approvable letter; 
Performance goal: Review time: 160 days; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 80%. 

Type of application: Premarket Notifications (510(k)s); 
FDA cycle actions and decisions: Decision: Issue decision letter (for 
example, a letter for a device that may be marketed because it is 
substantially equivalent to one already on the market, or that may not 
marketed because it is not substantially equivalent); 
Performance goal: Review time: 90 days; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 75%. 

Type of application: Premarket Notifications (510(k)s); 
FDA cycle actions and decisions: Cycle action: Issue first additional 
information letter; 
Performance goal: Review time: 75 days; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 70%. 

Type of application: Premarket Notifications (510(k)s); 
FDA cycle actions and decisions: Cycle action: Issue second or 
subsequent additional information letter; 
Performance goal: Review time: 60 days; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 70%. 

Type of application: BLA Resubmissions and BLA Supplement 
Resubmissions; 
FDA cycle actions and decisions: Cycle action: Review and act on a 
Class 1 resubmission to an original BLA or BLA supplement (for example, 
issue a letter requesting limited labeling or safety information from 
the manufacturer); 
Performance goal: Review time: 2 months; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 75%. 

Type of application: BLA Resubmissions and BLA Supplement 
Resubmissions; 
FDA cycle actions and decisions: Cycle action: Review and act on a 
Class 2 resubmission to an original BLA or BLA supplement (for example,
issue a letter requesting data on product safety and effectiveness 
from the manufacturer); 
Performance goal: Review time: 6 months; 
Performance goal: Percentage of applications received in fiscal year 
2005 cohort required to meet review time: 75%. 

Source: GAO analysis of HHS and FDA information as of March 31, 2004. 

[A] FDA groups these types of applications together when measuring 
performance for this goal. 

[End of table]

Limited Data to Measure FDA's Performance against the MDUFMA 
Performance Goals: 

FDA had limited data that could be used to measure the agency's 
performance against most of the MDUFMA performance goals. Thus, it is 
uncertain whether FDA will meet the MDUFMA performance goals for fiscal 
years 2003, 2004, and 2005. For fiscal year 2003, the two performance 
goals could be applied to 53 applications. However, as of March 31, 
2004, only one application was subject to a cycle action tied to one of 
the two MDUFMA performance goals. In its review of that application, 
FDA determined that the manufacturer provided a complete response to an 
approvable letter pending minor corrections or clarifications and made 
the decision to approve the application within the goal's time frame. 
For fiscal year 2004, there were no applications subject to the cycle 
action tied to the two fiscal year 2004 MDUFMA performance goals. In 
addition, the likelihood of FDA meeting the fiscal year 2005 MDUFMA 
performance goals is uncertain because FDA had performance data for 
some, but not all, of the MDUFMA performance goals that will be 
effective in fiscal year 2005. FDA's performance results could change 
as the agency completes its actions on all applications for which the 
performance goals apply.

Limited Data to Measure FDA's Performance against the MDUFMA 
Performance Goals Established for Fiscal Years 2003 and 2004: 

Limited data exist to measure FDA's performance against the two MDUFMA 
performance goals established for fiscal years 2003 and 2004. Our 
analysis shows that FDA received 43 PMAs, 7 Panel-Track Supplements, 
and 3 Expedited PMAs in the fiscal year 2003 cohort.[Footnote 14] As of 
March 31, 2004, one application--an Expedited PMA--had been subject to 
the cycle action tied to one of the two MDUFMA performance goals for 
fiscal year 2003.[Footnote 15] In its review of this application FDA 
determined that the manufacturer submitted a complete response to an 
approvable letter pending minor corrections or clarifications, and 
approved the application within 30 days. For PMAs and Panel-Track 
Supplements, the same MDUFMA performance goal applied for fiscal year 
2003. However, FDA did not have any applications that required the 
issuance of an approvable letter. Similarly, none of the 15 PMAs, 1 
Panel-Track Supplement, and 8 Expedited PMA applications from the 
fiscal year 2004 cohort required issuance of approvable letters.

Many of the applications from the fiscal years 2003 and 2004 cohorts 
were pending within the review process for FDA review actions or 
manufacturers' responses to FDA. Therefore, FDA's performance results 
are preliminary. In the fiscal year 2003 cohort, 21 of the 50 PMAs and 
Panel-Track Supplements and 1 of the 3 Expedited PMAs FDA received were 
pending as of March 31, 2004. Similarly, in the fiscal year 2004 
cohort, 13 of the 15 PMAs, 1 Panel-Track Supplement, and all 8 of the 
Expedited PMAs FDA received were pending action. Because FDA's 
performance against the MDUFMA performance goals is based on the 
percentages of actions the agency takes on applications within required 
review times, FDA's performance results could change as the agency 
completes actions on all applications for which the performance goals 
apply. Data were not readily available from FDA on the status of all 
pending applications within the review process. FDA anticipates having 
complete data by the end of fiscal year 2004.

Limited Performance Data to Determine the Likelihood of FDA Meeting the 
Fiscal Year 2005 MDUFMA Performance Goals: 

The likelihood of FDA meeting the MDUFMA performance goals for fiscal 
year 2005 is uncertain because data to measure the agency's performance 
are limited. Specifically, FDA had data that allowed us to compare its 
performance against some, but not all, of the 20 MDUFMA performance 
goals that will be effective in fiscal year 2005. For example, from the 
fiscal year 2003 cohort, data were available to compare FDA's 
performance against 17 of the 20 performance goals for fiscal year 
2005. FDA took actions on applications tied to 14 of the 17 performance 
goals within the established goal time frames. For 7 of the 14 
performance goals, FDA's performance was based on one or two actions on 
applications. FDA did not take actions within the established goal time 
frames on applications tied to 3 of the 17 performance goals. 
Similarly, from the fiscal year 2004 cohort, FDA had data for 11 of the 
20 MDUFMA performance goals. We found that FDA took actions on 
applications tied to each of the 11 performance goals within the 
established goal time frames. For 4 of the 11 performance goals, FDA's 
performance was based on no more than three actions on applications. 
(See table 3.): 

Table 3: Status of FDA's Performance for Fiscal Years 2003 and 2004 Compared to MDUFMA Performance Goals That Become Effective in Fiscal Year 2005: 

Type of application: PMAs, Panel-Track Supplements, and Premarket 
Reports[A]; 
Cycle actions and decisions: Cycle action: Issue first major deficiency 
letter requesting significant information from the manufacturer; 
Performance goal: Review time: 150 days; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 75; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: 85%; (22 of 26 cycle actions); 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: 100%; (2 of 2 cycle actions).

Type of application: PMAs, Panel-Track Supplements, and Premarket 
Reports[A]; 
Cycle actions and decisions: Decision: Issue decision letter (approval, 
approvable pending GMP inspection, approvable pending minor corrections 
or clarifications, not approvable, or denial) as a first action on an 
application; 
Performance goal: Review time: 180 days; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 75; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: 96%; (22 of 23 decisions); 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: 100%; (3 of 3 decisions).

Type of application: PMAs, Panel-Track Supplements, and Premarket 
Reports[A]; 
Cycle actions and decisions: Cycle action: Issue second or subsequent 
major deficiency letter requesting significant information from the 
manufacturer; 
Performance goal: Review time: 120 days; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 75; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: 100%; (1 of 1 cycle action); 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: [B].

Type of application: PMAs, Panel-Track Supplements, and Premarket 
Reports[A]; 
Cycle actions and decisions: Cycle action: Determine whether an 
amendment contains a complete response to a major deficiency or not 
approvable letter; 
Performance goal: Review time: 180 days; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 75; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: 89%; (8 of 9 cycle actions); 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: [B].

Type of application: PMAs, Panel-Track Supplements, and Premarket 
Reports[A]; 
Cycle actions and decisions: Cycle action: Review whether an amendment 
contains a complete response to an approvable letter pending minor 
corrections or clarifications and make a decision, such as approving 
the application; 
Performance goal: Review time: 30 days; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 90; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: [B]; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: [B].

Type of application: Expedited PMAs; 
Cycle actions and decisions: Decision: Issue decision letter (approval, 
approvable pending GMP inspection, approvable pending minor corrections 
or clarifications, not approvable, or denial) after taking a cycle 
action on an application; 
Performance goal: Review time: 300 days; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 70; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: 100%; (2 of 2 decisions); 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: [B].

Type of application: Expedited PMAs; 
Cycle actions and decisions: Cycle action: Issue first major deficiency 
letter requesting significant information from the manufacturer; 
Performance goal: Review time: 120 days; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 70; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: 100%; (2 of 2 cycle; 
actions); 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: 100%; (4 of 4 cycle actions).

Type of application: Expedited PMAs; 
Cycle actions and decisions: Decision: Issue decision letter (approval, 
approvable pending GMP inspection, approvable pending minor corrections 
or clarifications, not approvable, or denial) as a first action on an 
application; 
Performance goal: Review time: 170 days; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 70; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: 100%; (1 of 1 decision); 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: 100%; (1 of 1 decision).

Type of application: Expedited PMAs; 
Cycle actions and decisions: Cycle action: Issue second or subsequent 
major deficiency letter requesting additional information from the 
manufacturer; 
Performance goal: Review time: 100 days; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 70; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: [B]; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: [B].

Type of application: Expedited PMAs; 
Cycle actions and decisions: Cycle action: Determine whether an 
amendment contains a complete response to a major deficiency or not 
approvable letter; 
Performance goal: Review time: 170 days; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 70; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: 100%; (1 of 1 cycle action); 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: [B].

Type of application: Expedited PMAs; 
Cycle actions and decisions: Cycle action: Review whether an amendment 
contains a complete response to an approvable letter pending minor 
corrections or clarifications and make a decision, such as approving 
the application; 
Performance goal: Review time: 30 days; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 90; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: 100%; (1 of 1 cycle action); 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: [B].

Type of application: 180-day PMA Supplements; 
Cycle actions and decisions: Decision: Issue decision letter (approval, 
approvable pending GMP inspection, approvable pending minor corrections 
or clarifications, not approvable, or denial) after taking a cycle 
action on an application; 
Performance goal: Review time: 180 days; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 80; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: 95%; (194 of 205 decisions); 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: 100%; (15 of 15 decisions).

Type of application: 180-day PMA Supplements; 
Cycle actions and decisions: Decision: Issue a not approvable letter as 
a first action on an application; 
Performance goal: Review time: 120 days; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 80; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: 19%; (6 of 32 cycle actions); 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: 83%; (5 of 6 cycle actions).

Type of application: 180-day PMA Supplements; 
Cycle actions and decisions: Decision: Issue decision letter (approval, 
approvable pending GMP inspection, approvable pending minor corrections 
or clarifications, or denial) as a first action on an application; 
Performance goal: Review time: 180 days; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 80; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: 96%; (166 of 173 decisions); 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: 100%; (9 of 9; 
decisions).

Type of application: 180-day PMA Supplements; 
Cycle actions and decisions: Cycle action: Determine whether an 
amendment contains a complete response to a not approvable letter; 
Performance goal: Review time: 160 days; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 80; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: 100%; (15 of 15 cycle actions); 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: 100%; (1 of 1 cycle actions).

Type of application: 510(k)s; 
Cycle actions and decisions: Decision: Issue decision letter (for 
example, a letter for a device that may be marketed because it is 
substantially equivalent to one already on the market, or that may not 
be marketed because it is not substantially equivalent); 
Performance goal: Review time: 90 days; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 75; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: 80%; (2,869 of 3,598 decisions); 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: 96%; (865 of 904 decisions).

Type of application: 510(k)s; 
Cycle actions and decisions: Cycle action: Issue first additional 
information letter; 
Performance goal: Review time: 75 days; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 70; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: 58%; (1,004 of 1,718 cycle 
actions); 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: 74%; (375 of 504 cycle actions).

Type of application: 510(k)s; 
Cycle actions and decisions: Cycle action: Issue second or subsequent 
additional information letter; 
Performance goal: Review time: 60 days; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 70; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: 53%; (283 of 530 cycle actions); 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: 96%; (54 of 56 cycle actions).

Type of application: BLA Resubmissions and BLA Supplement 
Resubmissions; 
Cycle actions and decisions: Cycle action: Review and act on a Class 1 
resubmission to an original BLA or BLA supplement (for example, issue 
a letter requesting limited labeling or safety information from the 
manufacturer); 
Performance goal: Review time: 2 months; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 75; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: [B]; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: [B].

Type of application: BLA Resubmissions and BLA Supplement 
Resubmissions; 
Cycle actions and decisions: Cycle action: Review and act on a Class 2 
resubmission to an original BLA or BLA supplement (for example, issue 
a letter requesting data on product safety and effectiveness from the 
manufacturer); 
Performance goal: Review time: 6 months; 
Performance goal: Percentage of actions required to meet the goal for 
the 
fiscal year 2005 cohort: 75; 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2003 cohort: 100%; (2 of 2 cycle actions); 
Percentage of actions taken on applications within goal’s established 
time frame: Fiscal year 2004 cohort: [B].

Source: GAO analysis of FDA data as of March 31, 2004.

[A] FDA groups these types of applications when measuring performance 
for this goal. In both the fiscal year 2003 and 2004 cohorts, FDA did 
not receive any Premarket Report applications.

[B] FDA did not have any applications that required the agency to take 
the action tied to the performance goal.

[End of table]

As previously mentioned, many of the applications from the fiscal years 
2003 and 2004 cohorts are awaiting actions by FDA or responses from 
manufacturers. Our analysis of the applications pending within the 
review process shows that of the 4,175 applications received in the 
fiscal year 2003 cohort, 339, or 8 percent, were pending further action 
by FDA as of March 31, 2004. Of the 1,781 applications received in the 
fiscal year 2004 cohort, 859, or 48 percent, were also pending as of 
March 31, 2004. The number of applications pending varied by 
application type. (See table 4.) For example, in the fiscal year 2003 
cohort, 21--or 42 percent--of the 50 PMAs and Panel-Track Supplements 
were pending, while 316--or 8 percent--of the 3,914 510(k)s were 
pending further action by FDA. As FDA completes its actions on more 
applications, its performance results could change.

Table 4: Applications Pending within FDA's Review Process in the Fiscal 
Year 2003 Cohort and the First 6 Months of the Fiscal Year 2004 Cohort: 

Type of application: PMA and Panel-Track Supplements; 
Fiscal year 2003: Total number of applications: 50; 
Fiscal year 2003: Number (percentage) pending: 21; (42%); 
Fiscal year 2004: Total number of applications: 16; 
Fiscal year 2004: Number (percentage) pending: 13; (88%).

Type of application: Expedited PMAs; 
Fiscal year 2003: Total number of applications: 3; 
Fiscal year 2003: Number (percentage) pending: 1; (33%); 
Fiscal year 2004: Total number of applications: 8; 
Fiscal year 2004: Number (percentage) pending: 8; (100%).

Type of application: 180-Day PMA Supplements; 
Fiscal year 2003: Total number of applications: 206; 
Fiscal year 2003: Number (percentage) pending: 1; (1%); 
Fiscal year 2004: Total number of applications: 42; 
Fiscal year 2004: Number (percentage) pending: 27; (64%).

Type of application: 510(k)s; 
Fiscal year 2003: Total number of applications: 3,914; 
Fiscal year 2003: Number (percentage) pending: 316; (8%); 
Fiscal year 2004: Total number of applications: 1,714; 
Fiscal year 2004: Number (percentage) pending: 810; (47%).

Type of application: BLA Resubmissions and BLA Supplement 
Resubmissions; 
Fiscal year 2003: Total number of applications: 2; 
Fiscal year 2003: Number (percentage) pending: 0; (0%); 
Fiscal year 2004: Total number of applications: 1; 
Fiscal year 2004: Number (percentage) pending: 1; (100%).

Total; 
Fiscal year 2003: Total number of applications: 4,175; 
Fiscal year 2003: Number (percentage) pending: 339; (8%); 
Fiscal year 2004: Total number of applications: 1,781; 
Fiscal year 2004: Number (percentage) pending: 859; (48%).

Source: GAO analysis of FDA data. 

[End of table]

According to FDA officials, in fiscal year 2003, FDA began implementing 
activities that are intended to enhance its ability to meet MDUFMA 
performance goals that become effective in fiscal year 2005. These 
activities, identified in the Secretary of HHS's November 2002 letter 
establishing the MDUFMA performance goals, include hiring additional 
staff, consulting with experts outside the agency more frequently, and 
holding meetings with manufacturers to ensure high-quality applications 
are submitted to FDA. For example, in fiscal year 2003, CDRH hired 
staff for 67 new positions, such as medical officers, scientists, and 
engineers, to improve the timeliness of its device reviews. As of April 
2004, CDRH filled 23 of the 65 positions it plans to fill in fiscal 
year 2004. CBER also filled each of the 11 full-time equivalent 
positions that it received in fiscal year 2003 and planned to fill 9 
full-time equivalent positions during fiscal year 2004 to improve the 
timeliness of device reviews as well as other activities.[Footnote 16] 
In addition, to help FDA meet its performance goals, FDA held about 
100 meetings with manufacturers to discuss ways to improve the quality 
of applications prior to their submission.

FDA Obligated over $128 Million for Postmarket Medical Device 
Compliance Activities and Inspections in Fiscal Year 2002: 

In fiscal year 2002, FDA obligated about $128 million for postmarket 
medical device compliance activities, which include inspections of 
device manufacturers' establishments. FDA obligated about $109 million 
for compliance activities and about $19 million for inspections. Of the 
approximately $109 million, FDA obligated about $99 million for 
postmarket compliance activities that encompass outreach coordination, 
applied research, and laboratory analyses. Outreach coordination 
included funds for guidance to field staff on matters such as the 
reporting of problems with medical devices, epidemiology studies, 
device recalls, and other activities. Obligations for applied research 
included funding for activities such as the development of domestic and 
international standards to help provide reasonable assurance that 
medical devices are safe and effective. Obligations for laboratory 
analyses included funding for activities such as FDA laboratory-based 
investigations and scientific training for FDA inspection staff. FDA 
also obligated an estimated $10 million in rental expenses for office 
space for FDA staff who conduct compliance activities.[Footnote 17]

In fiscal year 2002, of the $19 million obligated for inspections, FDA 
obligated about $17 million for inspections of domestic and foreign 
establishments and about $2 million in estimated office space rental 
expenses for FDA staff who conduct inspections.[Footnote 18] These 
inspections included routine surveillance inspections to determine 
compliance with medical device regulations, inspections resulting from 
the reporting problems with devices or product recalls, and compliance 
inspections to collect evidence for pending enforcement actions.

Agency Comments: 

In commenting on a draft of this report, FDA generally agreed with our 
findings. FDA stated that it believes the agency has made a good start 
in its implementation of MDUFMA and FDA believes that its progress in 
meeting the MDUFMA performance goals is consistent with the extensive 
performance improvements the agency is expect to achieve each year 
through 2007. FDA provided technical comments primarily clarifying 
aspects of the medical device review process, which we incorporated as 
appropriate. FDA's comments are reprinted in appendix I.

We are sending copies of this report to the Secretary of HHS and the 
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 [Hyperlink, http://www.gao.gov]. If you or your staffs have 
questions about this report, please contact me at (202) 512-7119 or 
James McClyde at (202) 512-7152. Darryl Joyce, Donna Bulvin, and 
Krister Friday also made key contributions to this report.

Signed by: 

Marcia Crosse: 
Director, Health Care--Public Health and Military Health Care Issues: 

[End of section]

Appendixes: 

Appendix I: Comments from the Food and Drug Administration: 

DEPARTMENT OF HEALTH & HUMAN SERVICES:

Food and Drug Administration: 
Rockville MD 20857:

August 18, 2004:

Marcia G. Grosse, Ph.D.
Director, Health Care - Public Health and Military Health Care Issues:
United States Government Accountability Office: 
441 G Street, N.W., Room 5A14:
Washington, DC 20548:

Dear Dr. Crosse:

FDA appreciates the opportunity to review and provide comments on GAO's 
draft report, Data to Measure the Timeliness of Reviews of Medical 
Device Applications Are Limited. The draft is thorough, provides a good 
overview of the complex and challenging performance goals FDA is 
working to achieve under the Medical Device User Fee and Modernization 
Act of 2002 (MDUFMA), and we generally agree with GAO's findings. We 
are providing brief technical comments to improve the accuracy and 
completeness of GAO's description of FDA's medical device review 
processes and to provide additional suggestions where we believe minor 
clarifications would be helpful.

I believe FDA has made a good beginning in our implementation of 
MDUFMA. The performance goals that are the primary focus of your report 
are a key feature of MDUFMA, but only one of the challenges we are 
working to meet. We are also working to meet expectations for third-
party establishment inspections, the new regulatory requirements for 
reprocessed single-use devices, and new provisions for pediatric 
devices. While we work to make these and other improvements, we're also 
working to ensure that we maintain our performance in areas that don't 
have specific MDUFMA performance goals.

Although only two of MDUFMA's measurable performance goals were in 
effect for FY 2003 and FY 2004, our progress to date is, we believe, 
consistent with the extensive performance improvements we are expected 
to achieve each year through FY 2007. We will face some significant 
challenges as we work to meet all of MDUFMA's goals-this is 
particularly true for MDUFMA's cycle goals - but we believe we are now 
laying the foundation for future progress, even on the most difficult 
goals. We are successfully recruiting essential scientific and medical 
experts and we are expanding our consultation with experts outside the 
agency; these new resources strengthen our review processes and help us 
conduct quality reviews in less time.	We're working to improve and 
expand our guidance to industry, to consult with stakeholders as we 
make policy and program improvements, and to provide additional 
opportunities for direct communications with applicants. We are mindful 
of the need to be responsible custodians of the user fees and 
additional appropriations MDUFMA is providing, and we continue to 
invest these new resources where they will do the most good for the 
process for the review of device applications. We're also working hard 
to modernize our IT infrastructure to enable rapid, efficient reviews, 
and to position the agency for future electronic submissions and 
reviews. We look forward to continued cooperative efforts with all 
interested parties to ensure the MDUFMA legislation is recognized as an 
unqualified success.

Along with the entire FDA team, I am strongly committed to meeting 
MDUFMA's challenging performance goals and to making the other process 
improvements necessary to provide a fair, transparent, and predictable 
process to rapidly bring new medical devices to patients and the health 
care community.

If you have any questions concerning our comments, or need additional 
information to complete your final report, please feel free to contact 
me or Linda Kahan, Deputy Director, CDRH. Ms. Kahan may be reached at 
(301) 827-7975, or by e-mail at linda.kahan@fda.gov. Thank you again 
for allowing us to review and comment on your report.

Sincerely,

Signed for: 

Lester M. Crawford, D.V.M., Ph.D. 
Acting Commissioner of Food and Drugs: 

[End of section]

(290344): 

FOOTNOTES

[1] The 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. 

[2] Pub. L. No. 107-250, 116 Stat. 1588. 

[3] FDA's request for additional information on such applications is 
known as an "approvable" letter.

[4] Ch. 675, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 
301 et seq. (2000)). 

[5] In general, medical device applications for PMA that are reviewed 
by FDA include 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. 

[6] FDA uses the term 510(k) to refer to a premarket notification 
submission. 

[7] Substantial 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. 

[8] BLAs are used to request permission to introduce and license 
biological products into interstate commerce. 

[9] According to FDA officials, BLA applications go through a review 
process that is similar to the PMA review process. 

[10] The 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, studies that may include 
microbiological, toxicological, and engineering tests.

[11] According to FDA, approximately 13 percent of the PMAs, Panel-
Track Supplements, and Expedited PMA applications are referred to 
external advisory committees. 

[12] Except for BLA Resubmissions and BLA Supplement Resubmissions, 
there are also limits on the length of time manufacturers have to 
respond to the agency's requests for additional information. For 
example, as required by FDA regulation, manufacturers submitting 
amendments to PMAs have 180 days to respond 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 submitting amendments to 510(k)s have 30 days to respond 
to first or subsequent letters requesting additional information. For 
amendments to 510(k)s, manufacturers can apply for extensions of up to 
180 days from the date of the first or subsequent letters.

[13] FDA refers to cohorts as "receipt cohorts." 

[14] FDA received other types of applications in the fiscal year 2003 
and 2004 cohorts, but these types are not connected to the MDUFMA 
performance goals established for fiscal years 2003 and 2004. FDA did 
not receive any Premarket Report applications, the fourth type of 
application tied to the fiscal year 2003 and 2004 MDUFMA performance 
goals.

[15] The Expedited PMA is tied to one of the two MDUFMA performance 
goals. 

[16] CBER did not hire additional staff to work exclusively on device 
applications because its staff works with both devices and biologics. 
However, biologics account for the majority of CBER's resources.

[17] FDA does not include rental amounts for each center in its annual 
budget justification. Rental expenses are reported as a single amount 
for all centers. Therefore, the amounts obligated for rental expenses 
are estimated. 

[18] These amounts exclude obligations for inspections of mammography 
facilities under the Mammography Quality Standards Act of 1992. 
Mammography inspections are not postmarket device establishment 
inspections as described in section 704(g)(10)(B) of FDCA. 

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