Food and Drug Administration
Revenue Information on Certain Companies Participating in the Medical Device User Fee Program Gao ID: GAO-07-571R March 30, 2007The 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), 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. 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--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). All companies qualifying as small businesses under the $100 million threshold pay reduced fees when submitting applications subject to user fees. 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. 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. Congress 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). 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.
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.
GAO-07-571R, Food and Drug Administration: Revenue Information on Certain Companies Participating in the Medical Device User Fee Program
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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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