必赢亚娱乐官网(中国)有限公司

您当前位置:奥咨达医疗器械服务集团 >> 法规指南 >> 国际法规 >> 浏览文章

美国FDA 2012财务年度医疗器械收费状况

阅读: 2016年05月14日

美国FDA 2012财务年度医疗器械收费状况

 

  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

小规模企业(收入总额或销售额小于1亿美金)收费金额

上市前批准包括PMAPDPPMRBLA申请

220,050美金

55,013美金

小组追踪PMA补充申请

165,038美金

41,259美金

180PMA补充申请

33,008美金

8,252美金

实时PMA补充申请

15,404美金

3,851美金

上市前通告(510K)申请


4,049美金

2,024美金

III类产品周期性报告


7,702美金/

1,925美金/

机构注册


2,029美金


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美金,每申请1个副本加收15美金(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。


  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%

  企业注册年费:2011-2179      2012-2029,2012财务年度收费降低6.9%。

  奥咨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]

  -----------------------------------------------------------------------

  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.

  -----------------------------------------------------------------------

  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

  ----------------------------------------------------------------------------------------------------------------

  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

  -----------------------------------------------

  Cumulative Total............................................  ..............  ..............      18,003,760

  ----------------------------------------------------------------------------------------------------------------

  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

  ----------------------------------------------------------------------------------------------------------------

  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




(编辑:佚名 来源:本站原创)
分享按钮:
上一篇:美国FDA 第三方审核及清单
下一篇:美国FDA 2011财务年度的医疗器械收费状况

常用查询

    评审进度查询       |         医疗器械标准目录库       |         临床试验机构目录库       |         检测中心承检目录库

    医疗器械分类目录      |       医疗器械检测中心受检目录      |      国产必赢亚娱乐官网查询      |       进口必赢亚娱乐官网查询

更多>>

专家解读

奥咨达服务项目流程

临床试验
体外诊断试剂
进口注册
中国注册
质量管理体系
医械咨询
欧盟CE认证
美国FDA注册
海外注册
  • 经验丰富

    3000+医械客户,标准服务

  • 安全保障

    签订业务合同,资料专人管理

  • 合作无忧

    200+专业顾问,保质完成服务

  • 信誉卓著

    高新技术企业,信誉保障

  • 必赢亚娱乐官网|必赢亚娱乐官网

    XML 地图 | Sitemap 地图