弗锐达医疗器械咨询机构FDA工作组提醒医疗器械同业,美国 FDA 于2011年8月1日颁布了2012财务年度的医疗器械收费状况,如下表:
申请类型 | 对应情况 | 标准收费金额 | 小规模公司(收入总额或销售额小于1亿美元)收费金额 |
上市前批准包括PMA、PDP、PMR、BLA申请 | ① | 220,050美元 | 55,013美元 |
小组追踪PMA补充申请 | ② | 165,038美元 | 41,259美元 |
180天PMA补充申请 | ③ | 33,008美元 | 8,252美元 |
实时PMA补充申请 | ④ | 15,404美元 | 3,851美元 |
上市前通告(510K)申请 | 4,049美元 | 2,024美元 | |
III类产品周期性报告 | 7,702美元/年 | 1,925美元/年 | |
机构注册 | 2,029美元 | ||
由CDRH出◣具的出口证明(CFG) | 对由同一个生产企业在同一生产场所生产的一个或多个产品申请CFG:正本175美元,每申请1个副本加↓收15美元(包括与正本同时申请或得到正本后的补充申请)根据2011财务年度的医疗器械收费状况,弗锐达医疗器械咨询 |
机构对510k申请费和企业注册进行了比较:
510k申请费 :2011-4349 2012-4049,2012财务年度收费降低7.4%
企业卐注册年费:2011-2179 2012-2029,2012财务年度收费降低6.9%。
弗锐达医疗器械咨询机构提醒,以上内容以下面英文为主:
[Federal Register Volume 76, Number 147 (Monday, August 1, 2011)]
[Notices]
[Pages 45826-45831]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19335]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0542]
Medical Device User Fee Rates for Fiscal Year 2012
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the fee
rates and payment procedures for medical device user fees for fiscal
year (FY) 2012. The Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as amended by the Medical Device User Fee Amendments of 2007
(title II of the Food and Drug Administration Amendments Act of 2007
(FDAAA)), authorizes FDA to collect user fees for certain medical
device submissions, and annual fees for certain periodic reports and
for certain establishments subject to registration. The FY 2012 fee
rates are provided in this document. These fees apply from October 1,
2011, through September 30, 2012. To avoid delay in the review of your
application, you should pay the fee before or at the time you submit
your application to FDA. The fee you must pay is the fee that is in
effect on the later of the date that your application is received by
FDA or the date your fee payment is received. In order to pay a reduced
small business fee, you must qualify as a small business before you
make your submission to FDA; if you do not qualify as a small business
before you make your submission to FDA, you will be required to pay the
higher standard fee. This document provides information on how the fees
for FY 2012 were determined, the payment procedures you should follow,
and how you may qualify for reduced small business fees.
FOR FURTHER INFORMATION CONTACT: For information on the Medical Device
User Fee and Modernization Act (MDUFMA): visit FDA's Web site, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm.
For questions relating to this notice: Contact David Miller, Office
of Financial Management (HFA-100), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 301-796-7103.
SUPPLEMENTARY INFORMATION:
[[Page 45827]]
I. Background
Section 738 of the FD&C Act (21 U.S.C. 379j) establishes fees for
certain medical device applications, submissions, supplements, and
notices (for simplicity, this document refers to these collectively as
``submissions''); for periodic reporting on class III devices; and for
the registration of certain establishments. Under statutorily-defined
conditions, a qualified applicant may receive a fee waiver or may pay a
lower small business fee. (See 21 U.S.C. 379j(d) and (e)).
Under the FD&C Act, the fee rate for each type of submission is set
at a specified percentage of the standard fee for a premarket
application (a premarket application is a premarket approval
application (PMA), a product development protocol (PDP), or a biologics
license application (BLA)). The FD&C Act specifies the standard fee for
a premarket application for each year from FY 2008 through FY 2012;
however, the standard fee for a premarket application received by FDA
during FY 2012, which is set in the statute ($256,384), is adjusted in
accordance with the offset provisions of the FD&C Act. Using this
adjusted fee rate for FY 2012 as a starting point, this document
establishes FY 2012 fee rates for other types of submissions, and for
periodic reporting, by applying criteria specified in the FD&C Act.
The FD&C Act specifies the annual fee for establishment
registration for each year from FY 2008 through FY 2012; the
registration fee for FY 2012 is $2,364, which is also adjusted in
accordance with the offset provisions of the FD&C Act. There is no
reduction in the registration fee for small businesses. An
establishment must pay the registration fee if it is any of the
following types of establishment:
Manufacturer--An establishment that makes by any means any
article that is a device, including an establishment that sterilizes or
otherwise makes such article for or on behalf of a specification
developer or any other person.
Single-Use Device Reprocessor--An establishment that
performs additional processing and manufacturing operations on a
single-use device that has previously been used on a patient.
Specification Developer--An establishment that develops
specifications for a device that is distributed under the
establishment's name but which performs no manufacturing, including an
establishment that, in addition to developing specifications, also
arranges for the manufacturing of devices labeled with another
establishment's name by a contract manufacturer.
II. Offsetting Fee Amounts for Collections in Excess of Appropriations
in FY 2008 through FY 2011
Under the offset provision of the FD&C Act (see section 739(h)(4)
(21 U.S.C. 379j-11(h)(4))), if the cumulative amount of fees collected
during FY 2008 through FY 2010, together with the estimated amount to
be collected in FY 2011, exceeds the aggregate amounts specified to be
appropriated in these four FYs in section 739(h)(3) of the FD&C Act,
the aggregate amount in excess shall be credited to the appropriation
account of FDA and subtracted from the amount of fees that would
otherwise be collected in FY 2012. Table 1 of this document presents
the amount of MDUFMA fees collected during FY 2008 through FY 2010
(actuals), and the amount estimated to be collected in FY 2011, and
compares those amounts with the fees specified to be appropriated in
these four FYs in section 739(h)(3) of the FD&C Act.
Table 1--Statement of Fees Appropriated, Fees Collected, and Differences as of September 30, 2010
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Fees
Fiscal year appropriated Fees collected Difference
----------------------------------------------------------------------------------------------------------------
2008 Actual..................................................... $48,431,000 $49,314,691 $883,691
2009 Actual..................................................... 52,547,000 59,731,482 7,184,482
2010 Actual..................................................... 57,014,000 66,949,587 9,935,587
2011 Estimate................................................... 61,860,000 61,860,000 0
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Cumulative Total............................................ .............. .............. 18,003,760
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Unearned Revenue Included in Above Amount................... .............. .............. 8,491,930
Excess Collections Less Unearned Revenue (Offset Amount).... .............. .............. 9,511,830
----------------------------------------------------------------------------------------------------------------
The total amount FDA expects to have collected in excess of
appropriations by the end of FY 2011 is $18,003,760. However, of that
amount, a total of $8,491,930 represents unearned revenue--primarily
fees paid for applications that have not yet been received. The
unearned revenue is held in reserve either to refund, if no application
is submitted, or to apply toward the future FY when the application is
received. The net of these two figures, $9,511,830, is the amount that
FDA has received in excess of appropriations that is available for
obligation, and the amount by which fee revenue will be offset in FY
2012.
For FY 2012, the statute authorizes $67,118,000 in user fees (see
section 738(h)(3)(E)). In order to determine the revised collection
amount, we deduct the net excess collection amount of $9,511,830 from
$67,118,000, and the revised revenue target for FY 2012 becomes
$57,606,170. Stated as a percent, this is 85.8281 percent of the
original revenue target for FY 2012. Accordingly, if we multiply this
percentage by the revenue amounts for the two fees set in statute,
$256,384 for a Premarket Application fee and $2,364 for an
Establishment Registration Fee (see 21 U.S.C. 379j(b)), the reduced
fees for FY 2012 are $220,050 for a premarket application fee and
$2,029 for the annual establishment registration fee.
It is important to note that the appropriation for FY 2012 still
must be $67,118,000 as specified in the statute, so that the $9,511,830
in user fees collected in prior years is appropriated and available for
obligation.
III. Fees for FY 2012
Under the FD&C Act, all submission fees and the periodic reporting
fee are set as a percent of the standard (full) fee for a premarket
application (see 21 U.S.C. 379j(a)(2)(A)), and the offset fee for the
standard premarket application, including a BLA, a premarket report,
and an efficacy supplement, for FY 2012. As calculated previously, the
FY 2012 premarket application fee is $220,050. This is referred to as
the ``base fee.'' The fees set by reference to the base fee are as
follows:
For a panel-track supplement, 75 percent of the base fee;
[[Page 45828]]
For a 180-day supplement, 15 percent of the base fee;
For a real-time supplement, 7 percent of the base fee;
For a 30-day notice, 1.6 percent of the base fee;
For a 510(k) premarket notification, 1.84 percent of the
base fee;
For a 513(g) (21 U.S.C. 360(c)(g)) request for
classification information, 1.35 percent of the base fee; and
For an annual fee for periodic reporting concerning a
class III device, 3.5 percent of the base fee.
For all submissions other than a 510(k) premarket notification, a
30-day notice, and a 513(g) request for classification information, the
small business fee is 25 percent of the standard (full) fee. (See 21
U.S.C. 379j(d)(2)(C).) For a 510(k) premarket notification submission,
a 30-day notice, and a 513(g) request for classification information,
the small business fee is 50 percent of the standard (full) fee. (See
21 U.S.C. 379j(d)(2)(C) and 379j(e)(2)(C).)
The annual fee for establishment registration, after reduction as
calculated in the previous section, is $2,029 in FY 2012. There is no
small business rate for the annual establishment registration fee; all
establishments pay the same fee. The statute authorizes increases in
the annual establishment fee for FY 2011 and subsequent years if the
estimated number of establishments submitting fees for FY 2009 is fewer
than 12,250. (See 21 U.S.C. 379j(c)(2)(A).) The number of
establishments submitting fees in FY 2009 was in excess of 12,250, so
no establishment fee increase is warranted under this provision of the
statute.
Table 2 of this document sets out the FY 2012 rates for all medical
device fees.
Table 2--Medical Device Fees for FY 2012
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Standard Fee, as a Percent of
Application fee type the standard fee for a premarket FY 2012 FY 2012 small
application standard fee business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted under Set in statute at $256,382, but $220,050 $55,013
section 515(c)(1) of the FD&C Act (21 U.S.C. offset by multiplying by
360e(c)(1)), a PDP submitted under section 85.8281 percent.
515(f) of the FD&C Act, or a BLA submitted
under section 351 of the Public Health
Service (PHS) Act (42 U.S.C. 262)).
Premarket report (submitted under section 100%............................ 220,050 55,013
515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved BLA under 100%............................ 220,050 55,013
section 351 of the PHS Act).
Panel-track supplement........................ 75%............................. 165,038 41,259
180-day supplement............................ 15%............................. 33,008 8,252
Real-time supplement.......................... 7%.............................. 15,404 3,851
510(k) premarket notification submission...... 1.84%........................... 4,049 2,024
30-day notice................................. 1.6%............................ 3,521 1,760
513(g) (21 U.S.C. 360c(g)) request for 1.35%........................... 2,971 1,485
classification information.
----------------------------------------------------------------------------------------------------------------
Annual Fee Type
----------------------------------------------------------------------------------------------------------------
Annual fee for periodic reporting on a class 3.5%............................ 7,702 1,925
III device.
Annual establishment registration fee (to be Set in statute at $2,364, but 2,029 2,029
paid by each establishment that is a offset by multiplying by
manufacturer, a single-use device 85.8281 percent.
reprocessor, or a specification developer, as
defined by 21 U.S.C. 379i(13)).
----------------------------------------------------------------------------------------------------------------
IV. How to Qualify as a Small Business for Purposes of Medical Device
Fees
If your business has gross receipts or sales of no more than $100
million for the most recent tax year, you may qualify for reduced small
business fees. If your business has gross sales or receipts of no more
than $30 million, you may also qualify for a waiver of the fee for your
first premarket application (PMA, PDP, or BLA) or premarket report. You
must include the gross receipts or sales of all of your affiliates
along with your own gross receipts or sales when determining whether
you meet the $100 million or $30 million threshold. In order to pay the
small business fee rate