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entitled 'Food and Drug Administration: Revenue Information on Certain 
Companies Participating in the Medical Device User Fee Program' which 
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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),[Footnote 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.[Footnote 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. 

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 firm[Footnote 3]--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).[Footnote 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.[Footnote 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).[Footnote 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. 

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.[Footnote 
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. 

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,[Footnote 8] FDA is 
responsible for ensuring that medical devices are reasonably safe and 
effective, among other things, before they become commercially 
available.[Footnote 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.[Footnote 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.[Footnote 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. 

Table 1: Device Applications Subject to User Fees under MDUFMA in 
Fiscal Year 2006: 

Application: PMA; 
Purpose of application: 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; 
Standard user fee: $259,600; 
Small business discount user fee[A]: $98,648. 

Application: Product Development Protocol (PDP); 
Purpose of application: 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; 
Standard user fee: 259,600; 
Small business discount user fee[A]: 98,648. 

Application: Premarket Report; 
Purpose of application: 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; 
Standard user fee: 259,600; 
Small business discount user fee[A]: 98,648. 

Application: Panel-track PMA Supplement; 
Purpose of application: 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; 
Standard user fee: 259,600; 
Small business discount user fee[A]: 98,648. 

Application: 180-day PMA Supplements; 
Purpose of application: 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; 
Standard user fee: 55,814; 
Small business discount user fee[A]: 21,209. 

Application: Real-time PMA Supplement; 
Purpose of application: Request for approval of a minor change to an 
approved device, such as a minor change in the design or labeling; 
Standard user fee: 18,691; 
Small business discount user fee[A]: 7,103. 

Application: Premarket Notification/510(k)[B]; 
Purpose of application: Request for approval of a device that is 
substantially equivalent to a legally marketed device that was not 
subject to premarket approval; 
Standard user fee: 3,833; 
Small business discount user fee[A]: 3,066. 

Application: Biologics License Application (BLA); 
Purpose of application: Request for approval to introduce and license 
biological products for interstate commerce; 
Standard user fee: 259,600; 
Small business discount user fee[A]: 98,648. 

Application: BLA Efficacy Supplement; 
Purpose of application: A supplement to an approved premarket 
application that requires substantive clinical data; 
Standard user fee: 259,600; 
Small business discount user fee[A]: 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, Panel-track 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). 

[End of table] 

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: 

[See PDF for image] 

Source: GAO analysis of FDA data. 

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. 

[End of figure] 

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. 

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.[Footnote 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: 

[See PDF for image] 

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

[End of figure] 

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, 

Signed by: 

Randall B. Williamson: 
Acting Director, Health Care: 

Enclosures--3: 

[End of section] 

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.[Footnote 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.[Footnote 14] In total, we 
identified 133 subsidiary companies that were responsible for 740 of 
the remaining 2,994 applications. 

* 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.[Footnote 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. 

[End of section] 

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. 

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: 

Annual revenue (millions of dollars): $0; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 4; 
Companies. 

Annual revenue (millions of dollars): $0; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 13; 
Applications. 

Annual revenue (millions of dollars): >$1 to $25; 
Application type (fee in dollars): PMA ($259,600): 1; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 21; 
Companies. 

Annual revenue (millions of dollars): >$1 to $25; 
Application type (fee in dollars): PMA ($259,600): 1; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 33; 
Applications. 

Annual revenue (millions of dollars): >$25 to $50; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 11; 
Companies. 

Annual revenue (millions of dollars): >$25 to $50; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0;  
Application type (fee in dollars): 510(k) ($3,833): 31; 
Applications. 

Annual revenue (millions of dollars): >$50 to $75; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 1; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0;  
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 10; 
Companies. 

Annual revenue (millions of dollars): >$50 to $75; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 1; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 20; 
Applications. 

Annual revenue (millions of dollars): >$75 to $100; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 8; 
Companies. 

Annual revenue (millions of dollars): >$75 to $100; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 18; 
Applications. 

Annual revenue (millions of dollars): >$100 to $125; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 1; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
1; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 8; 
Companies. 

Annual revenue (millions of dollars): >$100 to $125; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 1; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
7; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 14; 
Applications. 

Annual revenue (millions of dollars): >$125 to $150; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 5; 
Companies. 

Annual revenue (millions of dollars): >$125 to $150; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 7; 
Applications. 

Annual revenue (millions of dollars): >$150 to $175; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 1; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 1; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
1; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 2; 
Companies. 

Annual revenue (millions of dollars): >$150 to $175; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 1; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 1; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
1; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 3; 
Applications. 

Annual revenue (millions of dollars): >$175 to $200; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 4; 
Companies. 

Annual revenue (millions of dollars): >$175 to $200; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 9; 
Applications. 

Annual revenue (millions of dollars): >$200 to $300; 
Application type (fee in dollars): PMA ($259,600): 1; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 2; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
1; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 6; 
Companies. 

Annual revenue (millions of dollars): >$200 to $300; 
Application type (fee in dollars): PMA ($259,600): 1; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 2; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
1; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 25; 
Applications. 

Annual revenue (millions of dollars): >$300 to $400; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 1; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
3; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 12; 
Companies. 

Annual revenue (millions of dollars): >$300 to $400; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 2; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
5; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 61; 
Applications. 

Annual revenue (millions of dollars): >$400 to $500; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 1; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 4; 
Companies. 

Annual revenue (millions of dollars): >$400 to $500; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 2; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 12; 
Applications. 

Annual revenue (millions of dollars): >$500 to $600; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
1; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 10; 
Companies. 

Annual revenue (millions of dollars): >$500 to $600; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
1; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 22; 
Applications. 

Annual revenue (millions of dollars): >$600 to $700; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 5; 
Companies. 

Annual revenue (millions of dollars): >$600 to $700; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 18; 
Applications. 

Annual revenue (millions of dollars): >$700 to $800; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 1; 
Companies. 

Annual revenue (millions of dollars): >$700 to $800; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 2; 
Applications. 

Annual revenue (millions of dollars): >$800 to $900; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 3; 
Companies. 

Annual revenue (millions of dollars): >$800 to $900; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 4; 
Applications. 

Annual revenue (millions of dollars): >$900 to $1,000; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 0; 
Companies. 

Annual revenue (millions of dollars): >$900 to $1,000; 
Application type (fee in dollars): PMA ($259,600): 0; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 0; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 0; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 0; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
0; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 0; 
Applications. 

Annual revenue (millions of dollars): More than $1,000; 
Application type (fee in dollars): PMA ($259,600): 12; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 2; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 8; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 
20; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
22; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 129; 
Companies. 

Annual revenue (millions of dollars): More than $1,000; 
Application type (fee in dollars): PMA ($259,600): 21; 
Application type (fee in dollars): PDP ($259,600): 0; 
Application type (fee in dollars): Premarket Report ($259,600): 0; 
Application type (fee in dollars): BLA ($259,600): 2; 
Application type (fee in dollars): Panel-Track PMA Supplement 
($259,600): 8; 
Application type (fee in dollars): 180-Day PMA Supplement ($55,814): 
78; 
Application type (fee in dollars): Real-Time PMA Supplement ($18,691): 
216; 
Application type (fee in dollars): BLA Efficacy Supplement ($259,600): 
0; 
Application type (fee in dollars): 510(k) ($3,833): 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. 

[End of table] 

[End of section] 

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): 

FOOTNOTES 

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

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

[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. 

[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. 

[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. 

[10] In 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. 

[11] For 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. 

[12] A 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. 

[13] To 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. 

[14] Subsidiary address information was not available in Mergent. 
Therefore, we matched applications to the Mergent database using name 
alone. 

[15] Both "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.  

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