United States Government Accountability Office

GAO Report to Congressional Committees

FOOD AND DRUG 

ADMINISTRATION 

Limited Available Data 

Indicate That FDA Has 

Been Meeting Some 

Goals for Review of 

Medical Device 

Applications

September 2005 

 

GAO-05-1042 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

September 2005

FOOD AND DRUG ADMINISTRATION

Limited Available Data Indicate That FDA 

Has Been Meeting Some Goals for 

Review of Medical Device Applications

Highlights of GAO-05-1042, a report to

congressional committees

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. www.gao.gov/cgi-bin/getrpt?GAO-05-1042.

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 or crossem@gao.gov.
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 

Page i GAO-05-1042 FDA's Review of Device Applications
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 protection in the

United States. It may be reproduced and distributed in its entirety without further 

permission from GAO. However, because this work may contain copyrighted images or

other material, permission from the copyright holder may be necessary if you wish to 

reproduce this material separately. 

Page ii GAO-05-1042 FDA's Review of Device Applications
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

 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, sec. 102(a), §§ 737 and 738, 116 Stat. 1588 (to be codified as amended 

at 21 U.S.C. §§ 379i and 379j).

Page 1 GAO-05-1042 FDA's Review of Device Applications
authorized FDA to collect user fees from manufacturers that submit

several types of applications to FDA for marketing medical devices. In 

return, MDUFMA requires FDA to meet performance goals tied to the 

review of certain medical device and biological license applications, at

least to the extent practicable. MDUFMA also required the Secretary of

Health and Human Services to develop the specific goals FDA must meet. 

The Secretary developed performance goals for fiscal years 2003 through 

2007. To help FDA meet the MDUFMA performance goals, the Secretary 

also identified several goal-related activities for FDA to undertake, such as

hiring additional review staff. 

MDUFMA performance goals are linked to certain actions FDA may take 

during the application review process and specify lengths of time for 

taking these actions. Data to measure FDA’s performance against the 

MDUFMA performance goals are based on the percentages of actions the 

agency takes on applications within specified time frames. For example,

one of the performance goals is linked to the time it takes FDA to review

and make a decision about certain applications to market devices that may

be substantially equivalent to devices that are already on the market. To 

meet the performance goal established for fiscal year 2005, FDA must

reach a decision about substantial equivalence within 90 days for 

75 percent of such applications received in the fiscal year. In general, the 

time frames established by MDUFMA performance goals do not hold FDA 

accountable for the time it takes manufacturers to respond to the agency if 

the agency determines that substantial additional information is needed 

before a decision can be reached. 

The number of MDUFMA performance goals that FDA must meet

increases over time, and the percentage of actions taken within the 

specified time frame for some goals also increases over time. For fiscal

years 2003 and 2004, FDA was to meet the same 2 performance goals for 

each year. For fiscal year 2005, FDA was to meet those 2 goals and an 

additional 18 performance goals, for a total of 20. For fiscal year 2006, FDA

is to meet these 20 goals and an additional 6 performance goals, for a total 

of 26. The goals established for fiscal year 2006 are tied to more types of 

applications than the goals established for fiscal year 2005. In addition, 16

of the performance goals established for fiscal year 2006 require that 

review actions be taken within the specified time frames on a higher

percentage of applications—for example, on 80 percent rather than 

75 percent of the applications—than was required for similar goals 

established for fiscal year 2005. 

Page 2 GAO-05-1042 FDA's Review of Device Applications
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). 

 3

See 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).

4

21 U.S.C. § 379j(g)(1)(B)(i)(II) (2000).

Page 3 GAO-05-1042 FDA's Review of Device Applications
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.

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 

Results in Brief

Page 4 GAO-05-1042 FDA's Review of Device Applications
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. 

Page 5 GAO-05-1042 FDA's Review of Device Applications
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. 

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

Background 

Types of Applications 

Reviewed under MDUFMA 

Performance Goals 

• Original Premarket Approval (PMA) applications are generally required 

when the device is new or when the risks associated with the device are 

considerable (as would be the case if the device is to be implanted in the 

body for life-supporting purposes). 

• Expedited PMAs are used when FDA has granted priority status to an 

application to market a medical device because it is intended to treat or

diagnose a life-threatening or irreversibly debilitating disease or condition 

and to address an unmet medical need. 

• Premarket Reports are applications required for high-risk devices 

originally approved for a single use (that is, use on a single patient during a 

single procedure) that a manufacturer has reprocessed for additional use.

 5

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

6

In 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. 

7

Some types of applications that involve biologics licenses are linked to MDUFMA

performance goals established for 2006, but not for 2005. 

Page 6 GAO-05-1042 FDA's Review of Device Applications
• Premarket Notifications, or 510(k)s,8

 are applications used when the intent

is to market a type of device that may be substantially equivalent

9

 to a 

legally marketed device that was not subject to premarket approval. 

• Panel-Track Supplements are applications used to supplement approved

PMAs or Premarket Reports. These supplements typically request

approval of a significant change in the design or performance of a device, 

or for a new purpose for using a device. 

• 180-Day PMA Supplements are also used to supplement approved PMAs or

Premarket Reports. These supplements typically request approval of a 

significant change in aspects of a device, such as its design, specifications, 

or labeling, when demonstration of reasonable assurance of safety and 

effectiveness either does not require new clinical data or requires only 

limited clinical data. 

• Biologics license applications (BLA) request permission to introduce and 

license biological products into interstate commerce. There are two types 

of BLAs that are tied to MDUFMA performance goals. Priority BLAs are 

for products that would, if approved, involve a significant improvement in

the safety or effectiveness of the treatment, diagnosis, or prevention of a 

serious or life-threatening disease. Nonpriority BLAs are considered 

standard BLAs. 

• BLA Supplements are used to supplement approved BLAs by requesting 

approval of a change to a licensed biological product. When the change 

has the substantial potential to affect the safety or effectiveness of the 

product, FDA approval is required prior to product distribution. There are

MDUFMA performance goals linked to three types of BLA supplements—

BLA manufacturing supplements that require prior approval and two types 

of BLA efficacy supplements. Manufacturing supplements that require 

prior approval address proposed changes in the manufacture of the 

biologic and generally do not require submission of substantive clinical

data. Efficacy supplements include both standard and priority efficacy 

supplements and require submission of substantive clinical data. 

• BLA Resubmissions and BLA Efficacy Supplement Resubmissions are 

used to respond to a letter from FDA indicating that the information 

included in a BLA or BLA Efficacy Supplement was deficient. FDA 

classifies these resubmissions into two groups according to the type of 

 8

FDA 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. §

360(k) (2000). 

9

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.

Page 7 GAO-05-1042 FDA's Review of Device Applications
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. 

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. 

Page 8 GAO-05-1042 FDA's Review of Device Applications
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 

Source: GAO.

Flow of review process

Action can be repeated

PMA application received by FDA from manufacturer

Multidisciplinary staff evaluation

Order 

approving 

application

"Approvable"

letter pending 

GMP 

inspection

"Approvable" 

letter pending 

minor 

corrections

or clarifications

"Not 

approvable" 

letter

Order

denying 

the application

Manufacturer 

may submit 

an amendment

Manufacturer 

may submit a

new application

Manufacturer 

may submit 

an amendment

Scientific

review

Decisions

May refer to external advisory 

committee for evaluation

If information is insufficient, issue 

"major deficiency" letter indicating 

what information is needed

Committee provides input on 

safety and effectiveness

Issue letter indicating what

information is needed

Page 9 GAO-05-1042 FDA's Review of Device Applications
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. 

The 510(k) Review Process 

Page 10 GAO-05-1042 FDA's Review of Device Applications
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.

510(k) application received by FDA from manufacturer

Staff evaluation

Manufacturer 

may submit 

additional

information

Scientific

review If information is insufficient, issue 

“additional information” letter 

indicating what information is needed

Device is substantially 

equivalent and may 

be marketed

Device is not substantially 

equivalent and may not

be marketed

A 510(k) application

was not required

Decisions

Source: GAO.

Flow of review process

Action is repeatable

The BLA Review Process 

Page 11 GAO-05-1042 FDA's Review of Device Applications
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 

BLA application or BLA supplement received by FDA from manufacturer

Multidisciplinary staff evaluation

Scientific

review May refer to external advisory committee for evaluation

“Approval” letter “Complete 

response” 

letter

Source: GAO.

Flow of review process

Action is repeatable

Manufacturer 

may submit a 

resubmission

Committee provides input on safety 

and effectiveness

Issue letter indicating what 

information is needed

Decisions

Measuring FDA’s 

Performance under 

MDUFMA 

Page 12 GAO-05-1042 FDA's Review of Device Applications
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. 

 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.” 

Page 13 GAO-05-1042 FDA's Review of Device Applications
Table 1: MDUFMA Performance Goals for Fiscal Years 2005 and 2006 

Performance goal 

Type of application 

FDA actions, including 

decisions Review time

Percentage of actions 

taken on applications 

received in fiscal year

2005 cohort required 

to meet review time 

Percentage of actions 

taken on applications 

received in fiscal year

2006 cohort required 

to meet review time

Issue a decision letter

b

PMAs, Panel-Track 320 days Not applicable 80

Supplements, and

Premarket Reports

a Issue a first major deficiency 

letter 

150 days 75 80

Issue a decision letter as a first 

action on an applicationb

 

180 days 75 80

Issue a second or subsequent

major deficiency letter 

120 days 75 80

Act on an amendment containing 

a complete response to a major 

deficiency or not approvable 

letter 

180 days 75 80

Act on an amendment containing 

a complete response to an 

approvable letter pending minor 

corrections or clarifications 

30 days 90 90

Issue a decision letter

b

 300 days 70 80

Issue a first major deficiency 

letter 

120 days 70 80

Issue a decision letter as a first 

action on an applicationb

 

170 days 70 80

Issue a second or subsequent

major deficiency letter 

100 days 70 80

Act on an amendment containing 

a complete response to a major 

deficiency or not approvable 

letter 

170 days 70 80

Expedited PMAs 

Act on an amendment containing 

a complete response to an 

approvable letter pending minor 

corrections or clarifications 

30 days 90 90

180-Day PMA Supplements Issue a decision letter

b

 180 days 80 80

Issue a not approvable letter as a 

first action on an application 

120 days 80 85

Issue a decision letter other than 

a not approvable letter as a first 

action on an applicationb

180 days 80 85

Act on an amendment containing 

a complete response to a not 

approvable letter 

160 days 80 85

Page 14 GAO-05-1042 FDA's Review of Device Applications
Performance goal 

Type of application 

FDA actions, including 

decisions Review time

Percentage of actions 

taken on applications 

received in fiscal year

2005 cohort required 

to meet review time 

Percentage of actions 

taken on applications 

received in fiscal year

2006 cohort required 

to meet review time

Issue a decision letter

c 90 days 75 75

Issue a first additional 

information letter 

75 days 70 80

510(k)s 

Issue a second or subsequent

additional information letter 

60 days 70 80

Review and act on a standard 

original BLA 

BLAs 10 months Not applicable 75

Review and act on a priority

original BLA 

6 months Not applicable 75

Review and act on a standard 

BLA efficacy supplement 

10 months Not applicable 75

Review and act on a priority BLA 

efficacy supplement 

6 months Not applicable 75

BLA Supplements 

Review and act on a BLA 

manufacturing supplement that

requires prior approval

4 months Not applicable 75

BLA Resubmissions and 

BLA Efficacy Supplement 

Resubmissions 

Review and act on a Class 

1 resubmission to an original

BLA or BLA efficacy supplement 

2 months 75 80

Review and act on a Class 

2 resubmission to an original

BLA or BLA efficacy supplement 

6 months 75 80

Source: GAO analysis of FDA data.

a

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

b

A 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.

c

A 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.

Page 15 GAO-05-1042 FDA's Review of Device Applications
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. 

Limited Available 

Data Indicate That 

FDA Has Been 

Meeting Some

Performance Goals 

Established for Fiscal 

Year 2005 

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 

Page 16 GAO-05-1042 FDA's Review of Device Applications
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. 

Page 17 GAO-05-1042 FDA's Review of Device Applications
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 

Available data are not sufficiently complete to evaluate performance against goal

Available data are sufficiently complete to evaluate performance against goal

2003 (22 of 26 actions)

2004 (23 of 28 actions)

2005 (7 of 7 actions)

2003 (23 of 24 actions)

2004 (19 of 20 actions)

2005 (3 of 3 actions)

2003 (2 of 2 actions)

2004 (3 of 3 actions)

2005 c

2003 (23 of 25 actions)

2004 (14 of 15 actions)

2005 c

2003 (1 of 2 actions)

2004 c

2005 c

2003 (3 of 3 decisions)

2004 (8 of 8 decisions)

2005 (1 of 1 decision)

2003 (2 of 2 actions)

2004 (8 of 10 actions)

2005 (1 of 1 action)

2003 (1 of 1 action)

2004 (1 of 4 actions)

2005 (1 of 1 action)

2003 c

2004 c

2005 c

2003 (2 of 2 actions)

2004 (4 of 5 actions)

2005 c

2003 (1 of 1 action)

2004 (1 of 1 action)

2005 c

2003 (194 of 206 decisions)

2004 (102 of 106 decisions)

2005 (18 of 18 decisions)

2003 (6 of 32 actions)

2004 (36 of 43 actions)

2005 (11 of 11 actions)

Type of application

PMAs, Panel-Track 

Supplements, and 

Premarket Reportsa

Expedited PMAs

180-Day PMA 

Supplements

Actions, including decisions

Issue a first major deficiency letter

Issue a decision letter as a first action on an applicationb

Issue a second or subsequent major deficiency letter

Act on an amendment containing a complete response 

to a major deficiency or not approvable letter

Act on an amendment containing a complete response 

to an approvable letter pending minor corrections or 

clarifications

Issue a decision letterb

Issue a first major deficiency letter

Issue a decision letter as a first action on an applicationb

Issue a second or subsequent major deficiency letter

Act on an amendment containing a complete response 

to a major deficiency or not approvable letter

Act on an amendment containing a complete response 

to an approvable letter pending minor corrections or 

clarifications

Issue a decision letterb

Issue a not approvable letter as a first action on an 

application

Performance 

goal’s review 

time 

150 days

180 days

120 days

180 days

30 days

300 days

120 days

170 days

100 days

170 days

30 days

180 days

120 days

0 20 40 60 80 100

0% 20% 40% 60% 80% 100%

75% 

required

75% 

required

75% 

required

75% 

required

90% 

required

70% 

required

70% 

required

70% 

required

70% 

required

70% 

required

80% 

required

90% 

required

80% 

required

d

d

Percentage of actions taken within goal’s review time as 

of March 31, 2005, for applications received in fiscal years 

2003, 2004, and 2005 as measured against performance

goals for fiscal year 2005

Page 18 GAO-05-1042 FDA's Review of Device Applications
Available data are not sufficiently complete to evaluate performance against goal

Available data are sufficiently complete to evaluate performance against goal

2003 (166 of 174 actions)

2004 (61 of 63 actions)

2005 (6 of 6 actions)

2003 (23 of 24 actions)

2004 (27 of 27 actions)

2005 c

2003 (2,887 of 3,790 decisions)

2004 (2,802 of 3,267 decisions)

2005 (920 of 933 decisions)

2003 (1,005 of 1,719 actions)

2004 (1,271 of 1,618 actions)

2005 (639 of 659 actions)

2003 (311 of 610 actions)

2004 (448 of 546 actions)

2005 (88 of 91 actions)

2003 f

2004 f

2005 g

2003 (2 of 2 actions)

2004 (4 of 5 actions)

2005 g

Type of application

180-Day PMA 

Supplements (cont’d)

510(k)s

BLA Resubmissions 

and BLA Efficacy

Supplement

Resubmissions 

Actions, including decisions

Issue a decision letter other than a not approvable letter 

as a first action on an applicationb

Act on an amendment containing a complete response 

to a not approvable letter

Issue a decision lettere

Issue a first additional information letter

Issue a second or subsequent additional 

information letter

Review and act on a Class 1 resubmission to an original 

BLA or BLA efficacy supplement

Review and act on a Class 2 resubmission to an original 

BLA or BLA efficacy supplement

Performance 

goal’s review 

time 

180 days

160 days

90 days

75 days

60 days

2 months

6 months

0% 20% 40% 60% 80% 100%

80% 

required

70% 

required

75% 

required

80% 

required

70% 

required

75% 

required

75% 

required

Percentage of actions taken within goal’s review time as 

of March 31, 2005, for applications received in fiscal years 

2003, 2004, and 2005 as measured against performance

goals for fiscal year 2005

Source: GAO analysis of FDA data.

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.

a

FDA 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.

b

A 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.

c

As 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.

d

This performance goal had also been established for fiscal years 2003 and 2004 and required 90 

percent of actions to be taken within 30 days.

e

A 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.

Page 19 GAO-05-1042 FDA's Review of Device Applications
f

FDA did not receive any submissions that required the agency to take the action tied to the 

performance goal. No additional submissions are possible.

g

As 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

 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. 

Page 20 GAO-05-1042 FDA's Review of Device Applications
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. 

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 

Fiscal year 2003 Fiscal year 2004 

First 6 months of fiscal 

year 2005 

Type of 

application 

Total number

of applications

Number

(percentage) 

pending 

Total number

of applications

Number

(percentage) 

pending

Total number of 

applications

Number

(percentage) 

pending

PMA and PanelTrack 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.

Page 21 GAO-05-1042 FDA's Review of Device Applications
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. 

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. 

Limited Available 

Data Suggest That 

FDA is Likely to Meet 

Some Performance 

Goals Established for 

Fiscal Year 2006

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

Page 22 GAO-05-1042 FDA's Review of Device Applications
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. 

Page 23 GAO-05-1042 FDA's Review of Device Applications
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 

Available data are not sufficiently complete to evaluate performance against goal

Available data are sufficiently complete to evaluate performance against goal

2003 (43 of 45 decisions)

2004 (35 of 35 decisions)

2005 (1 of 1 decisions)

2003 (22 of 26 actions)

2004 (23 of 28 actions)

2005 (7 of 7 actions)

2003 (23 of 24 actions)

2004 (19 of 20 actions)

2005 (3 of 3 actions)

2003 (2 of 2 actions)

2004 (3 of 3 actions)

2005 c

2003 (23 of 25 actions)

2004 (14 of 15 actions)

2005 c

2003 (1 of 2 actions)

2004 c

2005 c

2003 (3 of 3 decisions)

2004 (8 of 8 decisions)

2005 (1 of 1 decision)

2003 (2 of 2 actions)

2004 (8 of 10 actions)

2005 (1 of 1 action)

2003 (1 of 1 action)

2004 (1 of 4 actions)

2005 (1 of 1 action)

2003 c

2004 c

2005 c

2003 (2 of 2 actions)

2004 (4 of 5 actions)

2005 c

2003 (1 of 1 action)

2004 (1 of 1 action)

2005 c

2003 (194 of 206 decisions)

2004 (102 of 106 decisions)

2005 (18 of 18 decisions)

Type of application

PMAs, Panel-Track 

Supplements, and 

Premarket Reportsa

Expedited PMAs

180-Day PMA 

Supplements

Actions, including decisions

Issue a decision letterb

Issue a first major deficiency letter

Issue a decision letter as a first action on an applicationb

Issue a second or subsequent major deficiency letter

Act on an amendment containing a complete response 

to a major deficiency or not approvable letter

Act on an amendment containing a complete response 

to an approvable letter pending minor corrections or 

clarifictions

Issue a decision letterb

Issue a first major deficiency letter

Issue a decision letter as a first action on an applicationb

Issue a second or subsequent major deficiency letter

Act on an amendment containing a complete response 

to a major deficiency or not approvable letter

Act on an amendment containing a complete response 

to an approvable letter pending minor corrections or 

clarifications

Issue a decision letterb

Performance 

goal’s review 

time 

320 days

150 days

180 days

120 days

180 days

30 days

300 days

120 days

170 days

100 days

170 days

30 days

180 days

0 20 40 60 80 100

0% 20% 40% 60% 80% 100%

80% 

required

80% 

required

80% 

required

80% 

required

80% 

required

80% 

required

90% 

required

80% 

required

80% 

required

80% 

required

90% 

required

80% 

required

80% 

required

Percentage of actions taken within goal’s review time as 

of March 31, 2005, for applications received in fiscal years 

2003, 2004, and 2005 as measured against performance

goals for fiscal year 2006

Page 24 GAO-05-1042 FDA's Review of Device Applications
Page 25 GAO-05-1042 FDA's Review of Device Applications

Available data are not sufficiently complete to evaluate performance against goal

Available data are sufficiently complete to evaluate performance against goal

2003 (6 of 32 actions)

2004 (36 of 43 actions)

2005 (11 of 11 actions)

2003 (166 of 174 actions)

2004 (61 of 63 actions)

2005 (6 of 6 actions)

2003 (23 of 24 actions)

2004 (27 of 27 actions)

2005 c

2003 (2,887 of 3,790 decisions)

2004 (2,802 of 3,267 decisions)

2005 (920 of 933 decisions)

2003 (1,005 of 1,719 actions)

2004 (1,271 of 1,618 actions)

2005 (639 of 659 actions)

2003 (311 of 610 actions)

2004 (448 of 546 actions)

2005 (88 of 91 actions)

2003 e

2004 (8 of 8 actions)

2005 f

2003 e

2004 e

2005 c

2003 (3 of 3 actions)

2004 e

2005 c

2003 e

2004 e

2005 c

2003 (74 of 75 actions)

2004 (96 of 96 actions)

2005 (8 of 8 actions)

2003 e

2004 e

2005 f

2003 (2 of 2 actions)

2004 (4 of 5 actions)

2005 f

Type of application

180-Day PMA 

Supplements

(cont'd)

510(k)s

BLAs

BLA Supplements

BLA Resubmissions 

and BLA Efficacy 

Supplement 

Resubmissions

Actions, including decisions

Issue a not approvable letter as a first action on an 

application

Issue a decision letter other than a not approvable 

letter as a first action on an applicationb

Act on an amendment containing a complete response 

to a not approvable letter

Issue a decision letterb

Issue a first additional information letter

Issue a second or subsequent additional information 

letter

Review and act on a standard original BLA

Review and act on a priority original BLA

Review and act on a standard BLA efficacy supplement

Review and act on a priority BLA efficacy supplement

Review and act on a BLA manufacturing supplement 

that requires prior approval

Review and act on a Class 1 resubmission to an 

original BLA or BLA efficacy supplement

Review and act on a Class 2 resubmission to an 

original BLA or BLA efficacy supplement

Performance 

goal’s review 

time 

120 days

180 days

160 days

90 days

75 days

60 days

10 months

6 months

10 months

6 months

4 months

2 months

6 months

0 20 40 60 80 100

0% 20% 40% 60% 80% 100%

85% 

required

75% 

required

85% 

required

85% 

required

80% 

required

75% 

required

80% 

required

75% 

required

75% 

required

75% 

required

80% 

required

75% 

required

80% 

required

Percentage of actions taken within goal’s review time as 

of March 31, 2005, for applications received in fiscal years 

2003, 2004, and 2005 as measured against performance

goals for fiscal year 2006

Source: GAO analysis of FDA data.

Page 25 GAO-05-1042
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.

a

FDA 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.

b

A 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.

c

As 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.

d

A 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.

e

FDA did not receive any submissions that required the agency to take the action tied to the 

performance goal. No additional submissions are possible.

f

As 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 

Page 26 GAO-05-1042 FDA's Review of Device Applications
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. 

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 

Agency Comments 

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

Page 27 GAO-05-1042 FDA's Review of Device Applications
crossem@gao.gov. Contact points for our Offices of Congressional

Relations and Public Affairs may be found on the last page of this report. 

GAO staff who made major contributions to this report are listed in

appendix II.

Marcia Crosse 

Director, Health Care

Page 28 GAO-05-1042 FDA's Review of Device Applications
Appendix I: Comments from the Food and Appendix I: Comments from the Food and Drug Administration

Drug Administration 

Page 29 GAO-05-1042 FDA's Review of Device Applications
Ap

Ac

pendix II: GAO Contact and Staff

knowledgments

Page 30 GAO-05-1042

Appendix II: GAO Contact and Staff 

Acknowledgments 

GAO Contact Marcia Crosse, (202) 512-7119 or crossem@gao.gov

In addition to the contact named above, James McClyde, Assistant 

Director, and Kristen Joan Anderson made key contributions to this

report.

FDA's Review of Device Applications

Acknowledgments 

(290452)
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