a

GAO

United States Government Accountability Office

Report to Congressional Committees

August 2004 FOOD AND DRUG 

ADMINISTRATION

Data to Measure the 

Timeliness of Reviews 

of Medical Device 

Applications Are 

Limited

GAO-04-1022
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. 

Highlights of GAO-04-1022, a report to 

congressional committees 

August 2004

FOOD AND DRUG ADMINISTRATION

Data to Measure the Timeliness of 

Reviews of Medical Device Applications 

Are Limited 

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. 

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. 
Page i GAO-04-1022 FDA’s Review of Device Applications

Contents

Letter 1

Results in Brief 4

Background 5

Limited Data to Measure FDA’s Performance against the MDUFMA 

Performance Goals 16

FDA Obligated over $128 Million for Postmarket Medical Device 

Compliance Activities and Inspections in Fiscal Year 2002 23

Agency Comments 24

Appendix

Appendix I: Comments from the Food and Drug Administration 25

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

2004 13

Table 2: MDUFMA Performance Goals for Fiscal Year 2005 14

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 18

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 22

Figures Figure 1: PMA Review Process 8

Figure 2: 510(k) Review Process 11
Contents

Page ii GAO-04-1022 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

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 

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 1 GAO-04-1022 FDA’s Review of Device Applications

United States Government Accountability Office

Washington, D.C. 20548

A

August 30, 2004 Letr

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
Page 2 GAO-04-1022 FDA’s Review of Device Applications

resources to ensure prompt approval or clearance1 of applications for 

marketing medical devices and licensing biological products.2 MDUFMA 

authorized FDA to collect user fees from manufacturers that submit several 

types of applications to FDA for marketing medical devices. In return, 

MDUFMA requires FDA to meet performance goals tied to the review 

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,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 

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.
Page 3 GAO-04-1022 FDA’s Review of Device Applications

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 
Page 4 GAO-04-1022 FDA’s Review of Device Applications

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 
Page 5 GAO-04-1022 FDA’s Review of Device Applications

$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),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.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 

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. 
Page 6 GAO-04-1022 FDA’s Review of Device Applications

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,6 are applications used when the 

intent is to market a type of device that may be considered substantially 

equivalent7 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. 

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. 
Page 7 GAO-04-1022 FDA’s Review of Device Applications

• 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) 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.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 application10 and 

determines whether it is complete, that is, if it contains sufficient 

information to allow the review to continue. (See fig. 1.)

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. 

10The 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.
Page 8 GAO-04-1022 FDA’s Review of Device Applications

Figure 1: PMA Review Process

Source: GAO.

Flow of review process

Cycle action can be repeated

Application is 

incomplete Application is 

complete

Application is 

incomplete

First major deficiency letter requesting 

significant information from the manufacturer

Second or subsequent major 

deficiency letter requesting significant

information from the manufacturer

PMA application received by FDA from manufacturer

Multidisciplinary staff evaluation

May refer to external advisory committee for evaluation

Determination of application status

Order 

approving 

application

Approvable

letter pending 

GMP 

inspection

Approvable 

letter pending 

minor 

corrections

or clarifications

Not 

approvable 

letter

Order

denying 

the application

Determine whether amendment 

is a complete response

Complete response;

Issue order 

approving application

Amendment is not 

a complete response

Manufacturer 

submits an 

amendment

Manufacturer 

may submit a

new application

Manufacturer 

submits an 

amendment

Cycle action

Scientific

review

Committee submits recommendation 

to FDA on safety and effectiveness

Decisions

Cycle action

Cycle action
Page 9 GAO-04-1022 FDA’s Review of Device Applications

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.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.

11According to FDA, approximately 13 percent of the PMAs, Panel-Track Supplements, and 

Expedited PMA applications are referred to external advisory committees. 
Page 10 GAO-04-1022 FDA’s Review of Device Applications

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. 
Page 11 GAO-04-1022 FDA’s Review of Device Applications

Figure 2: 510(k) Review Process 

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 

510(k) application received by FDA from manufacturer

Source: GAO.

Cycle action

Manufacturer

submits 

additional

information Yes No

Yes

Device is substantially 

equivalent and may 

be marketed

No

Device is not substantially 

equivalent and may not

be marketed

Decisions

Insufficient information _ 

letter requesting additional 

information from manufacturer

Is device substantially equivalent to 

existing device on the market?

Sufficient information

Flow of review process

Cycle action is repeatable

Does the application have sufficient information to determine 

 substantial equivalence to a device on the market? 
Page 12 GAO-04-1022 FDA’s Review of Device Applications

a decision—but not the time it takes a manufacturer to respond to a 

request from FDA.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 cohort13—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).

12Except 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.

13FDA refers to cohorts as “receipt cohorts.” 
Page 13 GAO-04-1022 FDA’s Review of Device Applications

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

Source: GAO analysis of HHS and FDA information.

a

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

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. 

Type of application FDA cycle actions

Performance goal

Review time 

Percentage of applications received 

in each fiscal year required to meet 

review time 

Fiscal year 2003 

cohort

Fiscal year 2004 

cohort

PMAs, Panel-Track 

Supplements, and Premarket 

Reportsa

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 30 days 90 90

Expedited PMAs 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 30 days 90 90
Page 14 GAO-04-1022 FDA’s Review of Device Applications

Table 2: MDUFMA Performance Goals for Fiscal Year 2005

Type of application FDA cycle actions and decisions

Performance goal

Review time 

Percentage of 

applications received in 

fiscal year 2005 cohort 

required to meet review 

time 

PMAs, Panel-Track 

Supplements, and Premarket 

Reportsa

Cycle action: Issue first major deficiency letter 

requesting significant information from the 

manufacturer 150 days 75

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 180 days 75

Cycle action: Issue second or subsequent major 

deficiency letter requesting significant information 

from the manufacturer 120 days 75

Cycle action: Determine whether an amendment 

contains a complete response to a major 

deficiency or not approvable letter 180 days 75

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 30 days 90

Expedited PMAs 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 300 days 70

Cycle action: Issue first major deficiency letter 

requesting significant information from the 

manufacturer 120 days 70

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 170 days 70

Cycle action: Issue a second or subsequent major 

deficiency letter requesting significant information 

from the manufacturer 100 days 70

Cycle action: Determine whether an amendment 

contains a complete response to a major 

deficiency or not approvable letter 170 days 70
Page 15 GAO-04-1022 FDA’s Review of Device Applications

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.

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 30 days 90

180-day PMA Supplements 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 180 days 80

Decision: Issue a not approvable letter as a first 

action on an application 120 days 80

Decision: Issue decision letter (approval, 

approvable pending GMP inspection, approvable 

pending minor corrections or clarifications, or 

denial) as a first action on an application 180 days 80

Cycle action: Determine whether an amendment 

contains a complete response to a not approvable 

letter 160 days 80

Premarket Notifications 

(510(k)s)

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) 90 days 75

Cycle action: Issue first additional information 

letter 75 days 70

Cycle action: Issue second or subsequent

additional information letter 60 days 70

BLA Resubmissions and BLA 

Supplement Resubmissions

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) 2 months 75

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) 6 months 75

(Continued From Previous Page)

Type of application FDA cycle actions and decisions

Performance goal

Review time 

Percentage of 

applications received in 

fiscal year 2005 cohort 

required to meet review 

time 
Page 16 GAO-04-1022 FDA’s Review of Device Applications

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.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 2003.15 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.

14FDA 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.

15The Expedited PMA is tied to one of the two MDUFMA performance goals. 
Page 17 GAO-04-1022 FDA’s Review of Device Applications

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 PanelTrack 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.)
Page 18 GAO-04-1022 FDA’s Review of Device Applications

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 Cycle actions and decisions

Performance goal

Percentage of actions taken on 

applications within goal’s 

established time frame

Review 

time 

 Percentage 

of actions 

required to 

meet the goal 

for the fiscal 

year 2005 

cohort

Fiscal year 2003 

cohort

Fiscal year 2004 

cohort

PMAs, Panel-Track 

Supplements, and 

Premarket Reportsa

Cycle action: Issue first major deficiency 

letter requesting significant information 

from the manufacturer 

150 days 75

85%

(22 of 26 cycle 

actions)

100%

(2 of 2 cycle 

actions) 

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 180 days 75

96%

(22 of 23 decisions)

100%

(3 of 3 decisions) 

Cycle action: Issue second or 

subsequent major deficiency letter

requesting significant information from 

the manufacturer 120 days 75

100%

(1 of 1 cycle action)

b

Cycle action: Determine whether an 

amendment contains a complete 

response to a major deficiency or not 

approvable letter 180 days 75

89%

(8 of 9 cycle actions)

b

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 30 days 90

b b
Page 19 GAO-04-1022 FDA’s Review of Device Applications

Expedited PMAs 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 300 days 70

100%

(2 of 2 decisions)

b

Cycle action: Issue first major deficiency 

letter requesting significant information 

from the manufacturer

120 days 70

100%

(2 of 2 cycle

actions) 

100%

(4 of 4 cycle 

actions) 

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 170 days 70

100%

(1 of 1 decision)

100%

(1 of 1 decision) 

Cycle action: Issue second or 

subsequent major deficiency letter 

requesting additional information from 

the manufacturer 100 days 70

b b

Cycle action: Determine whether an 

amendment contains a complete 

response to a major deficiency or not 

approvable letter 170 days 70

100%

(1 of 1 cycle action)

b

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 30 days 90

100%

(1 of 1 cycle action)

b

(Continued From Previous Page)

 Type of application Cycle actions and decisions

Performance goal

Percentage of actions taken on 

applications within goal’s 

established time frame

Review 

time 

 Percentage 

of actions 

required to 

meet the goal 

for the fiscal 

year 2005 

cohort

Fiscal year 2003 

cohort

Fiscal year 2004 

cohort
Page 20 GAO-04-1022 FDA’s Review of Device Applications

180-day PMA 

Supplements

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 180 days 80

95%

(194 of 205 

decisions)

100%

(15 of 15 

decisions)

Decision: Issue a not approvable letter 

as a first action on an application

120 days 80

19%

(6 of 32 cycle 

actions) 

83%

(5 of 6 cycle 

actions)

Decision: Issue decision letter (approval, 

approvable pending GMP inspection, 

approvable pending minor corrections or 

clarifications, or denial) as a first action 

on an application 180 days 80

96%

(166 of 173 

decisions) 

100%

(9 of 9

decisions)

Cycle action: Determine whether an 

amendment contains a complete 

response to a not approvable letter

160 days 80

100%

(15 of 15 cycle 

actions) 

100%

(1 of 1 cycle 

actions)

510(k)s 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) 90 days 75

80%

(2,869 of 3,598 

decisions) 

96%

(865 of 904 

decisions)

Cycle action: Issue first additional 

information letter

75 days 70

58%

(1,004 of 1,718 cycle 

actions) 

74%

(375 of 504 cycle 

actions)

Cycle action: Issue second or 

subsequent additional information letter 

60 days 70

53%

(283 of 530 cycle 

actions) 

96%

(54 of 56 cycle 

actions)

(Continued From Previous Page)

 Type of application Cycle actions and decisions

Performance goal

Percentage of actions taken on 

applications within goal’s 

established time frame

Review 

time 

 Percentage 

of actions 

required to 

meet the goal 

for the fiscal 

year 2005 

cohort

Fiscal year 2003 

cohort

Fiscal year 2004 

cohort
Page 21 GAO-04-1022 FDA’s Review of Device Applications

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. 

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. 

BLA Resubmissions 

and BLA Supplement 

Resubmissions

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) 2 months 75

b b 

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) 6 months 75

100%

(2 of 2 cycle actions)

b

(Continued From Previous Page)

 Type of application Cycle actions and decisions

Performance goal

Percentage of actions taken on 

applications within goal’s 

established time frame

Review 

time 

 Percentage 

of actions 

required to 

meet the goal 

for the fiscal 

year 2005 

cohort

Fiscal year 2003 

cohort

Fiscal year 2004 

cohort
Page 22 GAO-04-1022 FDA’s Review of Device Applications

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 

Source: GAO analysis of FDA data.

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

 Fiscal year 2003 Fiscal year 2004

Type of application

Total number of 

applications

Number 

(percentage) 

pending 

Total number of 

applications

Number 

(percentage) 

pending

PMA and Panel-Track Supplements

 50

 21

(42%) 16

 13

 (88%)

Expedited PMAs

 3

 1 

 (33%) 8

 8 

 (100%)

180-Day PMA Supplements

 206

 1 

 (1%) 42

 27 

 (64%)

510(k)s

 3,914

 316

 (8%) 1,714

 810

 (47%)

BLA Resubmissions and BLA 

Supplement Resubmissions

 2

 0

 (0%) 1

 1 

 (100%)

Total 

 4,175

 339

 (8%) 1,781

 859

 (48%)
Page 23 GAO-04-1022 FDA’s Review of Device Applications

activities.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.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.18 These inspections 

included routine surveillance inspections to determine compliance with 

medical device regulations, inspections resulting from the reporting 

16CBER 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.

17FDA 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. 

18These 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. 
Page 24 GAO-04-1022 FDA’s Review of Device Applications

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 

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.

Marcia Crosse

Director, Health Care—Public Health

and Military Health Care Issues
Page 25 GAO-04-1022 FDA’s Review of Device Applications

Appendix I

Comments from the Food and Drug Apendxies

Administration ApendxiI
Appendix I

Comments from the Food and Drug 

Administration

(290344) Page 26 GAO-04-1022 FDA’s Review of Device Applications
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