United States Government Accountability Office

Washington, DC 20548 

March 30, 2007 

The Honorable Joe Barton 

Ranking Minority Member 

Committee on Energy and Commerce 

House of Representatives 

Subject: Food and Drug Administration: Revenue Information on Certain Companies 

Participating in the Medical Device User Fee Program

Dear Mr. Barton: 

The Food and Drug Administration (FDA) is responsible for approving medical devices—

such as catheters and artificial hearts—to provide reasonable assurance of their safety and 

effectiveness. As part of this responsibility, FDA, an agency within the Department of Health 

and Human Services (HHS), reviews applications submitted by medical device companies for 

devices they wish to market in the United States, including devices that are new or those that 

constitute modifications to already approved devices. Prior to 2002, members of Congress, 

representatives of the medical device industry, and others expressed concern that FDA 

lacked the resources necessary to complete such reviews in a timely manner to ensure that 

patients have access to useful, possibly life-saving, devices. In response, Congress enacted 

the Medical Device User Fee and Modernization Act of 2002 (MDUFMA),1

 which authorizes 

FDA to charge user fees for some device applications and not others. Revenues from the user 

fees, together with additional appropriations that were also authorized by MDUFMA, were 

intended to provide additional resources to FDA for improving the timeliness of device

review. In fiscal year 2005, FDA collected approximately $31 million in user fees from device 

applications. 

Under the MDUFMA user fee program, fees for individual medical device applications range 

from under $5,000 to more than $250,000.2

 Higher fees are charged for applications that

require more review. One of the applications with a higher user fee—$259,600 in fiscal year 

2006—is the Original Premarket Approval (PMA) application. A PMA is submitted for a 

device that supports or sustains human life, is of substantial importance in preventing 

impairment of human health, or presents a potential unreasonable risk of illness or injury. 

One of the applications with a lower user fee—$3,833 in fiscal year 2006—is a Premarket 

Notification. A Premarket Notification is submitted for devices that are substantially 

equivalent to a legally marketed device that was not subject to premarket approval. 

 1

Pub. L. No. 107-250, 116 Stat. 1588. 

2

MDUFMA includes provisions for user fee amounts for fiscal years 2006 and 2007.

 GAO-07-571R Financial Information on Device Companies 
To help ensure that user fees are not financially prohibitive for small medical device 

companies, MDUFMA provides that companies qualifying as small businesses in a given fiscal 

year can receive fee discounts and, in certain cases, fee waivers. To qualify as a small 

business under MDUFMA, a company must submit information to FDA demonstrating that its 

annual revenues—including the revenues of any affiliate, partner, or parent firm3

—are at or 

below a certain threshold. MDUFMA originally set the threshold for small business 

qualification at $30 million, and in 2005, the threshold was increased to $100 million by the 

Medical Device User Fee Stabilization Act of 2005 (MDUFSA).4 All companies qualifying as 

small businesses under the $100 million threshold pay reduced fees when submitting 

applications subject to user fees. In 2006, for example, the discounted PMA fee was $98,648,

or 38 percent of the full fee of $259,600. Originally, MDUFMA also provided that companies 

qualifying as small businesses receive a fee waiver the first time ever they submit one of 

certain applications that generally have higher fees.5

 While MDUFSA raised the small 

business threshold to $100 million, it provided that only companies with annual revenues of 

$30 million or less could continue to receive fee waivers. 

FDA’s authority to collect user fees will sunset October 1, 2007. You asked us to provide 

annual revenue information for companies participating in the MDUFMA user fee program to 

assist Congress as it determines whether changes to the threshold for small business 

qualification are needed. Revenue information is available for companies that qualify as small 

businesses, which submit annual revenue information to FDA, and publicly traded

companies, which register securities with, and submit annual revenue information to, the 

Securities and Exchange Commission (SEC).6

 In this report, we provide revenue information 

for (1) companies that qualified as small businesses under the MDUFMA user fee program in 

fiscal year 2006 and (2) companies publicly traded in the United States that submitted device 

applications subject to user fees and did not qualify as small businesses under MDUFMA in 

fiscal year 2006. 

 3

Specifically, MDUFMA requires companies to submit their most recent federal income tax returns to 

FDA so that FDA can verify the “gross sales or receipts” reported by the company and any affiliate, 

partner, or parent firm. 

4

Pub. L. No. 109-43, § 2(a)(3)(B)(iii), 119 Stat. 439, 440.

5

These applications include the PMA, the Biologics License Application (BLA), the Premarket Report,

and the Product Development Protocol (PDP). The user fee for each of these applications was 

$259,600 in fiscal year 2006. 

6

While companies seeking small business qualification must submit to FDA “gross sales or receipts” 

information from their most recent U.S. tax returns, companies that are publicly traded must submit to 

SEC gross revenue information in a financial income statement. Both gross sales or receipts and gross

revenues are general measures of annual revenue. However, annual revenues reported on a company’s

financial statement filed with SEC may not be identical to gross sales or receipts reported to the 

Internal Revenue Service for the same period. Taxable income reported on the tax return is computed

in accordance with prescribed federal tax regulations and rules, whereas, pretax financial income

reported on financial statements filed with SEC is measured in accordance with generally accepted

accounting principles (GAAP). Because tax regulations and GAAP are different, taxable income and

pretax financial income can differ. 

2 GAO-07-571R Financial Information on Device Companies
To provide annual revenues for companies qualifying as small businesses under the 

MDUFMA user fee program in fiscal year 2006, we obtained annual revenue data from FDA 

on these companies. To gather information about the MDUFMA user fee program, we 

interviewed FDA officials as well as representatives of the Medical Device Manufacturers 

Association. To provide annual revenues for companies publicly traded in the United States 

that submitted device applications subject to user fees and did not qualify as small businesses 

in fiscal year 2006, we obtained (1) company information from FDA on all device applications 

the agency received in fiscal year 2006 that were subject to user fees and (2) SEC data 

compiled by two private data vendors, Mergent and Audit Analytics. We then matched 

companies submitting device applications to publicly traded companies in the Audit 

Analytics and Mergent databases.7

 We assessed the reliability of FDA data by conducting 

interviews with FDA staff to understand how FDA collects and uses the data. We assessed 

the reliability of data from the two private data vendors by comparing actual financial 

information in SEC filings with financial information provided by the vendors for a sample of 

companies. Our results cannot be generalized to all companies that submitted device 

applications in fiscal year 2006. Together, companies qualifying as small businesses and 

publicly traded companies that were not qualified small businesses were responsible for 

about 50 percent of the approximately 4,500 device applications subject to user fees that 

were submitted in fiscal year 2006. We were unable to obtain revenue information for 

companies responsible for submitting the remaining 50 percent of applications. Because we 

identified applications submitted by companies that qualified as small businesses and 

publicly traded companies that did not qualify as small businesses, the remaining 

applications were likely submitted by private companies that did not qualify as small 

businesses. We were unable to identify the number of these companies. Enclosure I contains 

a more detailed description of our methodology. We conducted our work from October 2006 

through March 2007 according to generally accepted government auditing standards. 

Results in Brief 

Of the 697 companies that qualified as small businesses under the MDUFMA user fee 

program in fiscal year 2006, 656, or about 95 percent, had revenues at or below $30 million—

the threshold for small business qualification originally set by MDUFMA in 2002. Of the 41 

companies that had revenues above $30 million but at or below the current threshold of 

$100 million, 35 had revenues above $30 million but at or below $70 million. Of the 697 

companies that qualified as small businesses in fiscal year 2006, two-thirds submitted at least 

one device application subject to user fees during that year. These companies were 

responsible for about 20 percent of the approximately 4,500 device applications subject to 

user fees that were submitted to FDA in fiscal year 2006. 

We identified annual revenues for 258 publicly traded companies that submitted applications 

subject to user fees and did not qualify as small businesses in fiscal year 2006. Of these 

companies, 155, or about 60 percent, had annual revenues that were higher than $500 million. 

Another 47 companies had annual revenues above $100 million but at or below $500 million. 

 7

Companies that register their securities with SEC, which are referred to as registrants, may have

direct or indirect control of other companies, which are referred to as their subsidiaries. For the 

remainder of this report, “publicly traded company” refers to either a registrant or a subsidiary of a 

registrant. 

3 GAO-07-571R Financial Information on Device Companies
The remaining 56 companies had revenues at or below the current $100 million threshold for 

small business qualification. We did not determine why these companies were not qualified 

as small businesses. In total, the 258 publicly traded companies were responsible for about 

30 percent of the approximately 4,500 applications subject to user fees that were submitted 

to FDA in fiscal year 2006. 

HHS reviewed a draft of this report and provided technical comments, which we 

incorporated as appropriate. 

Background 

Under the Federal Food, Drug, and Cosmetic Act,8

 FDA is responsible for ensuring that 

medical devices are reasonably safe and effective, among other things, before they become 

commercially available.9

 Two FDA centers, the Center for Devices and Radiological Health 

(CDRH) and the Center for Biologics Evaluation and Research (CBER), are responsible for 

reviewing applications to market medical devices.10 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 

human immunodeficiency virus (HIV)), as well as therapeutic devices used in cell and gene 

therapies. 

Under MDUFMA, FDA is authorized to collect user fees from device companies for some 

device applications and not others.11 Companies that are not qualified small businesses pay 

the standard user fee for the applications they submit. Companies that qualify as small 

businesses by demonstrating that they meet the $100 million threshold pay a percentage of 

the standard user fee, with the amount of the discount depending on the application. In 

addition, the subset of companies that qualify as small businesses and have demonstrated 

annual revenues at or below $30 million receive a fee waiver the first time ever they submit 

one of certain applications that would have higher fees. Table 1 provides a description of the 

applications subject to user fees and the standard and discounted small business fees for 

fiscal year 2006. 

 8

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

9

Under the act, FDA is also responsible for ensuring that medical devices remain safe after they 

become commercially available. For example, FDA inspects medical device companies’ manufacturing 

establishments to assess compliance with good manufacturing practices. 

10In general, an application to market a medical device includes information on the device and its 

components. It also contains proposed labeling for the device and, when applicable, clinical and 

nonclinical studies that provide reasonable assurance of the device’s safety and effectiveness. 

11For example, FDA may charge a user fee for BLAs, which companies submit to FDA in order to

introduce and license biological products for interstate commerce. MDUFMA does not authorize FDA 

to charge a fee for a BLA manufacturing supplement, which is a request to change the manufacture of

an approved biological product and generally does not require submission of substantive clinical data. 

4 GAO-07-571R Financial Information on Device Companies
Table 1: Device Applications Subject to User Fees under MDUFMA in Fiscal Year 2006 

Application Purpose of application Standard user fee 

Small business 

discount user feea

PMA Request for approval of a device that 

supports or sustains human life, is of 

substantial importance in preventing 

impairment of human health, or which 

presents a potential unreasonable risk of 

illness or injury

$259,600 $98,648

Product 

Development 

Protocol (PDP)

An alternative review process for a device 

that would otherwise require a PMA; a key 

feature is that the applicant and FDA 

agree in advance concerning the data that 

must be developed to demonstrate that 

the device is safe and effective 

259,600 98,648

Premarket Report Request for approval of a high-risk device 

originally approved for single use—that is, 

use on a single patient during a single 

procedure—that a manufacturer has 

reprocessed for additional use

259,600 98,648

Panel-track PMA 

Supplement 

Request for approval of a significant 

change in the design or performance of an 

approved device, or for a new purpose for 

using the approved device, when 

demonstration of reasonable assurance of 

safety and effectiveness requires 

significant clinical data 

259,600 98,648

180-day PMA 

Supplements 

Request for approval of a significant 

change in aspects of an approved 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 

55,814 21,209

Real-time PMA 

Supplement 

Request for approval of a minor change to 

an approved device, such as a minor 

change in the design or labeling 

18,691 7,103

Premarket 

Notification/510(k)b

Request for approval of a device that is 

substantially equivalent to a legally 

marketed device that was not subject to 

premarket approval 

3,833 3,066

Biologics License 

Application (BLA) 

Request for approval to introduce and 

license biological products for interstate 

commerce 

259,600 98,648

BLA Efficacy 

Supplement 

A supplement to an approved premarket 

application that requires substantive 

clinical data 

259,600 98,648

Source: FDA. 

Note: Companies with annual revenues at or below $30 million receive a fee waiver the first time ever they submit a PMA, 

PDP, Premarket Report, or BLA as a qualified small business. 

a

The amount of the discounted user fee for a particular application is determined by multiplying the standard user fee for that 

application by a percentage amount specified by MDUFMA for that application. For PMAs, PDPs, Premarket Reports, Paneltrack PMA Supplements, 180-day PMA Supplements, Real-time PMA Supplements, BLAs, and BLA Efficacy Supplements, the

percentage is 38 percent. For Premarket Notifications, the percentage is 80 percent. 

b

FDA refers to a Premarket Notification submission as a 510(k) because the requirement for it is set out in § 510(k) of the 

Federal Food, Drug, and Cosmetic Act. 21 U.S.C. § 360(k) (2000). 

5 GAO-07-571R Financial Information on Device Companies
In order to evaluate a company for small business qualification, MDUFMA requires that FDA 

verify the “gross sales or receipts” reported on the most recent federal income tax returns by 

the company and any affiliate, partner, or parent firm. Companies must certify that they have 

furnished accurate copies of their income tax returns and those of any affiliate, partner, or 

parent firm. If a company cannot provide a copy of its most recent federal income tax return 

or that of any affiliate, partner, or parent firm—for example, if the company operates 

overseas and does not report some or all of its revenues on federal income tax returns—the 

company cannot qualify as a small business. 

Most Companies Qualifying as Small Businesses under the MDUFMA User Fee 

Program in Fiscal Year 2006 Had Annual Revenues at or below $30 Million 

We obtained annual revenues for 697 companies qualifying as small businesses in fiscal year 

2006. (See fig. 1.) According to FDA data, 656 of these companies, or about 95 percent, had 

revenues at or below $30 million—the threshold for small business qualification originally set 

by MDUFMA in 2002. Of the 41 companies that had revenues above $30 million but at or 

below the current threshold of $100 million set by MDUFSA in 2005, 35 had revenues above 

$30 million but at or below $70 million. 

Figure 1: Annual Revenues of Companies Qualifying as Small Businesses under the MDUFMA User Fee 

Program in Fiscal Year 2006

0

50

100

Number of companies

Annual revenue in millions

Source: GAO analysis of FDA data.

> $0 to $10

> $10 to $20

> $20 to $30

> $30 to $40

> $40 to $50

> $50 to $60

> $60 to $70

> $70 to $80

> $80 to $90

> $90 to 

 $100

500

550

600

<<

<

<<

<

<

<

<

<

9

579

27

50

15

6 5 3 2 1

Small business

threshold under

MDUFMA

Small business

threshold under

MDUFSA

Note: MDUFMA originally set the threshold for small business qualification at $30 million. In 2005, MDUFSA modified

MDUFMA by, among other things, raising the threshold for small business qualification to $100 million. 

About two-thirds of the 697 companies qualifying as small businesses in fiscal year 2006 

submitted a device application subject to user fees during that year. Specifically, 439

companies submitted at least one application that year, and these companies were 

responsible for about 20 percent of the approximately 4,500 applications subject to user fees 

that were submitted to FDA in fiscal year 2006. 

6 GAO-07-571R Financial Information on Device Companies
Most Publicly Traded Companies That Submitted Device Applications and Were 

Not Qualified Small Businesses Had Annual Revenues above $500 Million in 

Fiscal Year 2006 

We obtained annual revenues for 258 publicly traded companies that submitted device 

applications subject to user fees and did not qualify as small businesses in fiscal year 2006. 

(See fig. 2.) Using SEC data we obtained from two private data vendors, we found that 155 of 

these companies, or about 60 percent, had annual revenues above $500 million. An additional 

47 companies had annual revenues above $100 million but at or below $500 million for fiscal 

year 2006. The remaining 56 companies had annual revenues at or below the current small 

business threshold of $100 million, including 4 companies that reported revenues of $0.12

Altogether, these 258 publicly traded companies were responsible for about 30 percent of the 

approximately 4,500 applications subject to user fees that were submitted to FDA in fiscal 

year 2006. Enclosure II contains more information on the types and numbers of device

applications the companies submitted. 

Figure 2: Annual Revenues for Publicly Traded Companies That Submitted Device Applications Subject 

to MDUFMA User Fees in Fiscal Year 2006 and Did Not Qualify as Small Businesses 

0

20

40

60

80

100

120

140

160

4

52

22

8

13

4

Small business 155

threshold under

MDUFSA

Number of companies

Annual revenue in millions

Source: GAO analysis of FDA, Audit Analytics, and Mergent data.

$0

< > $100 to $200

< > $0 to $100

<

> $200 to $300

< > $300 to $400

< > $400 to $500

> $500

 12A company may report annual revenues of $0 if, for example, the company was new and at the time it

filed its report with SEC it had not yet generated revenues. 

7 GAO-07-571R Financial Information on Device Companies
We did not determine why each of the 56 publicly traded companies with annual revenues at 

or below $100 million was not qualified as a small business. One possible explanation 

provided by a medical device industry representative is that some companies that meet the 

current threshold for small business qualification may not apply if the discount in user fees 

for the device applications they are likely to submit is relatively small. Among the 56

companies we found with annual revenues at or below $100 million, all but one of the 

applications they submitted in fiscal year 2006 were Premarket Notifications. The Premarket 

Notification is the least expensive application and subject to the smallest discount. For fiscal 

year 2006, the standard user fee amount for the Premarket Notification was $3,833. In 

contrast, the user fee for companies qualifying as small businesses was $3,066. 

Agency Comments 

HHS reviewed a draft of this report and provided technical comments, which we 

incorporated as appropriate. 

- - - - - 

We are sending copies of this report to the Secretary of Health and Human Services, 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 will be 

available at no charge on GAO’s Web site at http://www.gao.gov. If you or your staff have 

questions about this report, please contact me at (206) 287-4860 or williamsonr@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 enclosure III. 

Sincerely yours, 

Randall B. Williamson 

Acting Director, Health Care 

Enclosures—3 

8 GAO-07-571R Financial Information on Device Companies
Enclosure I Enclosure I 

 

Scope and Methodology 

To provide annual revenues for the 697 companies that qualified as small businesses under 

the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) user fee program in 

fiscal year 2006, we obtained from the Food and Drug Administration (FDA) the number of 

these companies falling into $10-million increments of gross sales and receipts from $0 to 

$100 million. FDA collects and tabulates annual revenue information from tax returns that 

these companies provide to FDA as part of the small business qualification process. In order 

to qualify as a small business in fiscal year 2006, a company had to demonstrate that its total 

annual revenue—specifically, its gross sales or receipts and that of any affiliate, partner, or 

parent firm as recorded on the most recent U.S. federal income tax returns—did not exceed

$100 million. 

To provide total annual revenues for publicly traded companies that submitted device 

applications subject to user fees and did not qualify as small businesses in fiscal year 2006, 

we conducted a multistep analysis: 

• First, we obtained from FDA information on all 4,454 device applications the agency

received that year that were subject to user fees. 

• Second, we obtained from FDA the names and addresses of the 697 companies that 

qualified as small businesses under the MDUFMA user fee program in fiscal year 2006 and 

identified the 783 device applications they submitted by comparing company names and 

addresses between the 4,454 device applications and the list of 697 companies.13 This left 

3,671 applications subject to user fees that were submitted to FDA in fiscal year 2006 by 

companies that did not qualify as small businesses. 

• Third, we used two private databases containing information on publicly traded 

companies to identify 258 publicly traded companies that were responsible for 1,417 of 

the remaining 3,671 applications. The first database we used, Audit Analytics, contains the 

names, addresses, and annual revenues of publicly traded companies that register their 

securities with the Securities and Exchange Commission (SEC), known as registrants. We 

identified 125 registrants that were responsible for 677 of the 3,671 applications by 

comparing company names and addresses between the Audit Analytics database and the 

3,671 device applications. The second private database we used, Mergent, contains the 

names of companies that are subsidiaries of registrants. (Audit Analytics does not contain 

this information.) We used Mergent to identify applications submitted by companies that 

were subsidiaries of registrants. We did this by comparing subsidiary names with the 

company names on the remaining applications.14 In total, we identified 133 subsidiary 

companies that were responsible for 740 of the remaining 2,994 applications. 

13To determine whether an application belonged to a company on the list of qualified small businesses, 

we compared the names and addresses listed on the application and the list. If the names and 

addresses matched exactly, we considered the application to belong to the company. We also

considered an application to belong to a company if we deemed the match was probable in that the

two names were very similar. This methodology for comparison of company names and addresses was 

used throughout our analyses. 

14Subsidiary address information was not available in Mergent. Therefore, we matched applications to 

the Mergent database using name alone.

9 GAO-07-571R Financial Information on Device Companies
Enclosure I Enclosure I 

 

• Fourth, we used the Audit Analytics database to obtain annual revenues for the 258

companies we identified as publicly traded. Our methodology was based on FDA’s 

methodology to assess revenues for small business qualification. FDA defines a 

company’s annual revenue as the gross sales or receipts for that company and any 

affiliate, partner, or parent firm. When a company registers its securities with SEC, it must 

file consolidated financial statements indicating annual revenues—specifically, gross 

revenues—from all its operations, including those for its subsidiary companies.15

Therefore, for the 125 companies we matched with registrants in the Audit Analytics 

database, we used the annual revenue indicated for those companies in the same 

database. For the 133 companies we identified in Mergent as subsidiaries of registrants, 

we deemed that their associated registrants would be affiliate, partner, or parent firms; 

therefore, we used the annual revenue for the registrant indicated in the Audit Analytics 

database as the annual revenue for the subsidiary company.

Once we identified applications submitted by companies qualifying as small businesses and 

applications submitted by publicly traded companies, 2,254 applications remained—about 

50 percent of all 4,454 applications subject to user fees in fiscal year 2006. These applications 

are likely from companies that are private. 

After assessing the reliability of FDA data and SEC data compiled by Audit Analytics and 

Mergent, we found that both sets of data were suitable for our purposes. We assessed the 

reliability of FDA data by conducting interviews with FDA staff to understand how FDA 

collects and uses the data. We assessed the reliability of data from the two private data 

vendors by comparing financial information in SEC filings with financial information 

provided by the vendors for a sample of companies. To gather information about the 

MDUFMA user fee program, we interviewed officials from FDA, including officials from the 

two centers within FDA responsible for reviewing applications for medical devices—the 

Center for Devices and Radiological Health and the Center for Biologics Evaluation and 

Research. In addition, we interviewed representatives from a national trade association—the 

Medical Device Manufacturers Association—which represents manufacturers of medical 

devices. We conducted our work from October 2006 through March 2007 according to

generally accepted government auditing standards. 

15Both “gross sales or receipts” as reported on federal income tax returns and gross revenues as 

reported on a company’s financial statement filed with SEC are general measures of annual revenue.

However, they may not be identical for the same period. Taxable income reported on the tax return is 

computed in accordance with prescribed federal tax regulations and rules, whereas, pretax financial

income reported on financial statements filed with SEC is measured in accordance with generally

accepted accounting principles (GAAP). Because tax regulations and GAAP are different in many

ways, taxable income and pretax financial income can differ. 

10 GAO-07-571R Financial Information on Device Companies
Enclosure II Enclosure II 

Information on Device Applications Submitted by Publicly Traded Companies Not 

Qualified as Small Businesses, Categorized by Annual Company Revenue 

Under MDUFMA, medical device companies must pay user fees when they submit certain 

device applications. These applications are as follows: 

• Original Premarket Approvals (PMA) 

• Product Development Protocols (PDP) 

• Premarket Reports 

• Panel-track PMA Supplements 

• 180-day PMA Supplements 

• Real-time PMA Supplements 

• Premarket Notifications/510(k)s 

• Biologics License Applications (BLA) 

• BLA Efficacy Supplements 

In table 2, we provide detailed results of our analysis of device applications from companies 

publicly traded in the United States that submitted device applications subject to user fees 

and did not qualify as small businesses. We derived these results by obtaining application 

information from FDA, excluding applications from companies qualifying for small business 

discounts and waivers, and matching the companies responsible for the remaining 

applications to the revenues they reported to SEC, which we obtained from two private data 

vendors, Audit Analytics and Mergent. 

11 GAO-07-571R Financial Information on Device Companies 
Enclosure II Enclosure II 

Table 2: Annual Revenues for 258 Publicly Traded Companies Not Qualified as Small Businesses, Categorized by the 

Number of Device Applications per Application Type, in Fiscal Year 2006 

Application type (fee in dollars) 

Annual revenue 

(millions of dollars) 

PMA ($259,600)PDP ($259,600)Premarket Report ($259,600)BLA ($259,600)Pan

el-Track 

PMA Supple

m

ent 

($259,600)180-Day PMA Supple

m

ent 

($55,814)Real-Time PMA Supple

m

ent 

($18,691)BLA Efficacy Supple

m

ent 

($259,600)510(k) ($3,833)

$0 0 0 0 0 0 0 0 0 4 Companies 

0 0 0 0 0 0 0 0 13 Applications 

>$1 to ≤$25 1 0 0 0 0 0 0 0 21 Companies

1 0 0 0 0 0 0 0 33 Applications 

>$25 to ≤$50 0 0 0 0 0 0 0 0 11 Companies 

0 0 0 0 0 0 0 0 31 Applications 

>$50 to ≤$75 0 0 0 0 1 0 0 0 10 Companies

0 0 0 0 1 0 0 0 20 Applications 

>$75 to ≤$100 0 0 0 0 0 0 0 0 8 Companies 

0 0 0 0 0 0 0 0 18 Applications 

>$100 to ≤$125 0 0 0 0 0 1 1 0 8 Companies 

0 0 0 0 0 1 7 0 14 Applications 

>$125 to ≤$150 0 0 0 0 0 0 0 0 5 Companies 

0 0 0 0 0 0 0 0 7 Applications 

>$150 to ≤$175 0 0 0 0 1 1 1 0 2 Companies 

0 0 0 0 1 1 1 0 3 Applications 

>$175 to ≤$200 0 0 0 0 0 0 0 0 4 Companies

0 0 0 0 0 0 0 0 9 Applications 

>$200 to ≤$300 1 0 0 0 0 2 1 0 6 Companies 

1 0 0 0 0 2 1 0 25 Applications 

>$300 to ≤$400 0 0 0 0 0 1 3 0 12 Companies 

0 0 0 0 0 2 5 0 61 Applications 

>$400 to ≤$500 0 0 0 0 0 1 0 0 4 Companies 

0 0 0 0 0 2 0 0 12 Applications 

>$500 to ≤$600 0 0 0 0 0 0 1 0 10 Companies 

0 0 0 0 0 0 1 0 22 Applications 

>$600 to ≤$700 0 0 0 0 0 0 0 0 5 Companies 

0 0 0 0 0 0 0 0 18 Applications 

>$700 to ≤$800 0 0 0 0 0 0 0 0 1 Companies 

0 0 0 0 0 0 0 0 2 Applications 

>$800 to ≤$900 0 0 0 0 0 0 0 0 3 Companies 

0 0 0 0 0 0 0 0 4 Applications 

>$900 to ≤$1,000 0 0 0 0 0 0 0 0 0 Companies

0 0 0 0 0 0 0 0 0 Applications

More than $1,000 12 0 0 2 8 20 22 0 129 Companies 

21 0 0 2 8 78 216 0 759 Applications 

Source: GAO analysis of FDA, Audit Analytics, and Mergent data. 

Note: Shading for emphasis only. In addition, individual companies may appear in more than one column in the same row if they submit more 

than one type of application. As a result, the number of companies in this table does not sum to 258. 

12 GAO-07-571R Financial Information on Device Companies
Enclosure III Enclosure III 

GAO Contact and Staff Acknowledgments 

GAO Contact 

Randall B. Williamson, (206) 287-4860 or williamsonr@gao.gov

Acknowledgments 

In addition to the contact named above, James Musselwhite, Assistant Director; Donald Neff, 

Assistant Director; Ramsey Asaly; Cathy Hamann; Jessica Morris; Daniel Ries; and Yorick F. 

Uzes made key contributions to this report. 

(290610) 

13 GAO-07-571R Financial Information on Device Companies 
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. 
GAO’s Mission The Government Accountability Office, the audit, evaluation and 

investigative arm of Congress, exists to support Congress in meeting its 

constitutional responsibilities and to help improve the performance and 

accountability of the federal government for the American people. GAO 

examines the use of public funds; evaluates federal programs and policies; 

and provides analyses, recommendations, and other assistance to help

Congress make informed oversight, policy, and funding decisions. GAO’s 

commitment to good government is reflected in its core values of 

accountability, integrity, and reliability. 

The fastest and easiest way to obtain copies of GAO documents at no cost

is through GAO’s Web site (www.gao.gov). Each weekday, GAO posts 

newly released reports, testimony, and correspondence on its Web site. To

have GAO e-mail you a list of newly posted products every afternoon, go 

to www.gao.gov and select “Subscribe to Updates.” 

The first copy of each printed report is free. Additional copies are $2 each. 

A check or money order should be made out to the Superintendent of 

Documents. GAO also accepts VISA and Mastercard. Orders for 100 or 

more copies mailed to a single address are discounted 25 percent. Orders 

should be sent to: 

U.S. Government Accountability Office 

441 G Street NW, Room LM 

Washington, D.C. 20548 

To order by Phone: Voice: (202) 512-6000 

TDD: (202) 512-2537 

Fax: (202) 512-6061 

Contact: 

Web site: www.gao.gov/fraudnet/fraudnet.htm

E-mail: fraudnet@gao.gov

Automated answering system: (800) 424-5454 or (202) 512-7470 

Gloria Jarmon, Managing Director, JarmonG@gao.gov (202) 512-4400 

U.S. Government Accountability Office, 441 G Street NW, Room 7125 

Washington, D.C. 20548 

Paul Anderson, Managing Director, AndersonP1@gao.gov (202) 512-4800

U.S. Government Accountability Office, 441 G Street NW, Room 7149 

Washington, D.C. 20548 

Obtaining Copies of 

GAO Reports and 

Testimony

Order by Mail or Phone 

To Report Fraud,

Waste, and Abuse in 

Federal Programs 

Congressional 

Relations 

Public Affairs 

PRINTED ON RECYCLED PAPER