Dear Registered Establishment and Other Stakeholders:
致医疗用品企业的正式代表:

The United States Food and Drug Administration (U.S.FDA) is announcing the medical device user fee rates and payment procedures for fiscal year (FY) 2008.(October1.2007-September30,2008 ).The Federal Food, Drug, and Cosmetic Act (FD&C), as amended by the Medical Device User Fee Amendments of 2007 (“the 2007 Amendments”),authorizes FDA to collect user fees for certain medical device applications and submissions, for periodic reporting on class 111 devices, and for the registration of certain establishments.
美国FDA宣布向医疗用品企业征收2008年度的注册年费（2007年10月1日-2008年9月30日）.根据2007年医疗用品使用费修订的联邦食品，药物和化妆品法（FD&C）规定 ，授权FDA，集中收取用户费用包括特定医疗设备的申请，及第三类医疗用品定期做出报告和特定企业注册费。.

To avoid any delay in the review of an application or submission, your payment must be received by FDA on or before the time the submission is received by FDA. If you have not paid all fees owed, FDA will consider your submission incomplete and will not accept it for review. If you are a small business, you may qualify for reduced fees, and you may also qualify for a waiver of the fee for your first Premarket Application.
为了避免任何延误，在申请审查或提交时，你的付款必须汇到FDA或之前的时间提交到FDA。如果你还没有支付所欠的费用，FDA将因为你提交的信息不完整，不接受审查。如果你是一个小公司，你有资格可以申请减费，同时你也有资格申请豁免有关首次上市申请的费用。

New –Annual Fee for Establishment Registration
注册年费的新规定

The 2007Amendments require certain medical device establishments to pay an annual registration fee. (See Enclosed Letter-Establishment Registration Fees and Electronic Registration and Listing for Medical Device Establishments.

2007年修正案规定医疗用品企业需要每年交纳登记的费用（见所附的信中规定的医疗用品企业的登记费用及电子注册费用).

For fiscal year 2008 . (October1.2007-September30, 2008 ) ,the fee for registration of any establishment is :

所有医疗用品企业2008年度（2007.10.1-2008.9.30）的登记注册费用如下：
每个企业2008年度的登记注册费用为＄1.706

There are no small business fee waivers or reduced fees for establishment registration. If you do not pay a required establishment registration fee, your registration will be considered incomplete and your establishment is deemed to have failed to register in accordance with section 510.

小企业不能减免或降低登记注册费用. 按照第510条，如果你不付注册登记费，你的登记将被视为不完整的而你的登记也被视为已无法向政府注册.
New – Additional Types of Submissions are subject to a Fee.
新的规定-其他类型的提请书都必须交费

The 2007Amendments make two additional types of submissions subject to user fees: a 30-day Notice and a Request for Classification Information {513(g) Request}.If you make one of these submissions on or after October1.2007, you must pay a fee, as shown in the table on the back of this page.
2007年的修正案添加了两个关于用户费用意见的补充项目类型：为期30天的通知，和信息分类要求。如果你在2007年10月1日当天或者之后提出这些申请书其中的一个，你必须交纳一定的费用，请见在此页后面的列表.

New –Annual Fee for Periodic Reporting on a Class 111 Device
新规定-对第三类医疗用品定期报告的年费

If you market a class 111 device that is subject to periodic reporting (e.g., you are required to submit an annual concerning the device), you must pay an annual fee, as shown in the table on the back of this page.
如果你在市场上出售第三类医疗用品,这种医疗用品应有定期报告（例如你被提交这个医疗用品的年度报告），那么你必须付年费，见此页后面的列表.
All Existing Fees are Reduced Beginning FY2008??
所有现有的收费项目从2008年度开始减少
The standard and small business fees that apply in FY2007 will be significantly reduced beginning October1, 2007 .The new fees are shown in the table on the back of this page.
在2007年度申请的标准和小型企业的费用将在2007年10月1日起大大减少。新的收费标准在此页后面的表中。

The FY2008 fee rates apply to submissions made on or after October1.2007.If FDA receives both your submission and your payment before October1.2007, you will pay the fee in effect for FY2007.If FDA receives either your application or your payment after September30,2008, you will have to pay the fee for an FY2009 submission (fees for FY2009 will be published in the Federal
Register in early August 2008).

2008年度的费率应用于2007年10月1日当天或之后。
如果FDA在2007年10月1日之前收到申请书和付费，那么你的付费将在2007年度有效。如果FDA在2008年9月30日之后收到申请或者年费，那么需要支付2009年度的申请费用。2008年8月将在联邦登记册上刊登2009年度的注册费用.

If you want to pay the small business fee rate for an application or submission, or you want to receive a waiver of the fee for your first premarket application, you must quality as a small business before you send your submission to FDA. Your gross receipts or sales, including the gross receipts or sales of all of your affiliates, must not exceed $100 million (and must not exceed $30 million to quality for a waiver of the fee for your first Premarket Application).To learn how to quality as a small business, see FDA’s guidance document, FY2008 Medical Device Small Business Qualification and Certification, available at http://www.fda.gov/cdrh/mdufma.

如果你想支付小型企业申请费率，或者想减免有关费用，你必须符合作为小企业的资格，请一定在提交给FDA.你的销售额或总收益，包括你的所有分支机构的总收益或销售额，不得超过1亿美元（并且不得超过3000万美元，才有资格豁免首次上市申请的费用）根据FDA的指导性文件来学习如何定位一个小企业，可在http://www.fda.gov/cdrh/mdufma 网站上进行2008年度医疗器械小型企业的资格认证.

New—Foreign Businesses Can Now Qualify for Small Business Fees
新规定-国外企业，现在有资格按小型企业付费

The 2007 Amendments permit a foreign business to qualify as a small business and pay the small business fee
without submitting a Federal (U.S.) income tax return. You will have to submit information to FDA, including a Certification from your National Taxing Authority showing that your gross receipts or sales, including the gross
receipts or sales of all of your affiliates, do not exceed $100 million when expressed in U.S. dollars. To learn how
a foreign business can qualify as a small business, see FDA’s guidance document, FY 2008 Medical Device
Small Business Qualification and Certification, available at http://www.fda.gov/cdrh/mdufma.

2007年的修正案，准许外国以企业作为一个小企业并缴纳小型企业的费用,不提交美国联邦（U.S.）的所得税.你将要提交资料给美国食品药品管理局，其中包括，从你的国家征税机构所出示的证明，显示你的总收益或销售额，包括你所有分支机构的总收益或销售额，用美元衡量不得超过1个亿。根据FDA的指导性文件来学习如何定位一个小企业，可在http://www.fda.gov/cdrh/mdufma 网站上查看2008年度医疗器械小型企业的资格认证.

Fee for Medical Device Application, Submissions, and Periodic Reporting
医疗器材的申请，陈述以及定期报告的费用

The 2007 Amendments reduce the standard and small business fees for all applications and submissions that
were subject to a fee in FY 2007. For fiscal year 2008 (October 1, 2007-September 30, 2008), the fees for
medical device applications, submissions, and periodic reported are:

2007年修订案将降低2007年度收取的所有标准和小型企业的申请报告和产品提请书的费用. 2008年度（ 2007年10月1日- 2008年9月30日），医疗用品申请，产品提请书和产品周期报告的费用如下：

Do NOT send payment to FDA with your application. Additional information, including instructions on how and
where to send payment and how to qualify as a small business, is available at: http://www.fda.gov/cdrh/msufma.

不要寄给FDA你的费用伴随你的申请书，附加的信息，包括介绍如何和那里付款，以及如何有资格作为一个小型企业，可以登录网站查阅： http://www.fda.gov/cdrh/msufma 。

The Division of Small Manufactures, International and Consumer Assistance (DSMICA) can answer questions
Concerning the new law and help you find guidance documents and other reference materials. DSMICA can be
Contacted by phone at 800-638-2041 or 240-276-3150 or by email at dsmica@fda.hhs.gov. Questions regarding
Products regulated by the Center for Biologics Evaluation and Research should be directed to the Office of
Communication, Training and Manufactures Assistance (OCTMA). OCTMA can be contacted by phone at (301)
827-2000 or (800) 835-4709 or by email at matt@cber.fda.gov

小生产者、国际和消费者协助部（DSMICA），可以回答有关新的法律的问题，并帮助你找到指导文件及其他参考资料. 小生产者、国际和消费者协助部（DSMICA）可以通过电话800-638-204或者是电子邮件dsmica@fda.hhs.gov. 来联系。有关由生物制品评价和研究中心管制的产品的问题，可直接联络(OCTMA).办公室. (OCTMA) 可以通过电话301-827-2000或者800-835-4709或者是电子邮件matt@cber.fda.gov来联系。

Additional information regarding medical device user fee is available at: http://www.fda.gov/cdrh/mdufma
对于医疗设备使用费的附加信息，公众可以的登陆网站http://www.fda.gov/cdrh/mdufma查阅.

Sincerely yours,

John Stigi, Director Division of Small Manufactures, International and Consumer Assistance, please
contact at: dsmica@fda.hhs.go
John Stigi, 小生产者、国际和消费者协助部主任
联络方式： dsmica@fda.hhs.gov

Establishment Registration Fees and Electronic Registration and Listing for Medical Device Establishments
关于医疗用品企业的注册费和电子注册及列表的规定问答
To: Official Correspondents of medical device establishments
致医疗用品企业的正式代表：
Effective October 1,2007 ,FDA will require:
自2007年10月1日生效 FDA要求
A user fee to be paid for certain types of establishment registrations and Electronic registration of medical device establishments and the listings produced or processed by these establishments.
特定类型企业的注册费 电子注册 医疗用品企业注册和产品列名

The following questions and answers provide additional information about electronic registration and listing and other changes to the program.
以下问题将提供由电子注册和产品列名更详细的内容

1. What are the changes in the annual registration process ?
每年的注册过程有哪些变化？
1. All establishments must register and list electronically.
所有企业都必须使用电子注册和列名
2. The period for annual registration will be from October 1st to December 31stof each year Establishments will list at the same time they complete their annual registration requirements.
注册期为每年的10月1日至12月31日，当企业完成了所有注册要求后，企业将被列名
3. There is now a fee for annual registration for certain types of establishments. See the section, “who is required to pay the establishment fee?” Your registration is not complete until we notify you that all requirements have been met.
现在对于特定类型的企业要收费。请见问题“什么样的企业必须交费？”直到我们通知您所有的要求都达到标准你的注册才能完成。

2 Who must complete a 2008 annual registration?
谁必须完成2008年的注册？
All firms that are currently registered must complete an annual registration. In addition, all contract manufacturers and contract sterilizers (establishments that sterilize or otherwise make a device for a specification developer or any other person) must also now register each year.
所有现在已注册的医疗用品企业，都必须完成年注册。另外所有代工生产企业和灭菌消毒企业也必须每年注册.

3. When do I complete the 2008 annual registration?
什么时候完成2008年度注册？
All 2008 annual registration must be complete electronically between October 1,2007 and December 31,2007.

所有2008年度注册都必须用电子方式在2007年10月1日至2007年12月31日之间完成.

4. .Who is required to pay the establishment registration fee?
谁必须支付企业注册费？
The following types of establishments are required to pay the establishment registration fee:
以下的企业要求付注册费
Device manufacturers 医疗用品生产企业
Contract sterilizers (establishments that sterilize a device for a specification developer or any other person)协议消毒灭菌企业
Contract manufacturers (establishments that make a device for a specification developer or any other person)协议生产企业
Single-use device reprocessors单一使用医疗用品再制造公司
Specification developers特殊产品的研发公司

5. What is the establishment registration fee for fiscal year 2008 ?
2008年度的注册费用是多少？
The establishment registration fee for fiscal year 2008is $1,706.
2008年度的注册费用是1706美元

6. How do I submit my registration for 2008 electronically?
怎么样采用电子方式提交2008年度企业注册？
There are five basic steps for submitting your 2008 electronically:2008年度企业注册的电子提交方式分以下5个步骤：
1. You will be sent an account ID and password /PIN via email.
你将收到企业账户名称和密码
2. Use the account ID and password to log on to our site at: http://www.access.fda.gov/cdrh/oaa.
用新账号和密码进入FDA的网站http://www.access.fda.gov/cdrh/oaa.
3. Review the registration information for your establishment and make any updates.
核查贵公司的注册信息并更新
4. Review your listing information (if you are required to list your devices) and make updates. See “how do I submit my Listing information?”
审核贵公司医疗用品的信息并更新（如果你被要求列出你的产品信息）看“怎么样采用电子方式提交我的产品列表信息？”
5. Submit payment if you are required to do so.
如果贵公司属于特定公司则必须提交注册费
Online help will be available for each of the steps listed above.
网上可以提供帮助

7. How do I submit payment for the annual establishment registration fee?
如何提交企业注册年费？
Follow the instructions on the screen to make your payment .Be sure to allow for enough time for your payment to be received and recorded. This process can take up to two weeks. Your registration is not complete until FDA notifies you that all requirements have been met. That notification will be sent to you via email.

按照屏幕上的说明提交年费，请确保有足够的时间使您的付款和备案完成。这个过程最多2个星期.你的注册必须在FDA通知你所有要求都符合后才可以完成.正式通知将通过E-mail送达.

8. When is my registration for 2008 completed?
我的2008年度公司注册什么时候可以完成？
Your registration is complete when you have entered the information electronically at our site, have paid the establishment registration fee (if you are required to do so), and have received notification from us that all requirements have been met. That notification will be sent to you via email.
当你用电子方式提交你的信息并按规定支付费用并从FDA处收到正式通知的E-mail时，即为注册完成.

9. Will my current registration and listing data be moved to the new electronic system?
我公司的现有信息和产品信息会转移到新的电子系统中吗？
Yes. All of the registration and listing information that we have on file for your
establishment and your products will be moved to new system. You may, however,
be required to update certain product information when you first log into the electronic
system.是的。所有信息都将转移到新的系统中，当你登录新的系统时，你可以更新有关的内容.

10. Who id required to list their devices?
谁被要求列出他们的医疗用品？
All firms, with one exception, that are currently required to register must also list their
devices at the time of the annual registration. Initial Importers are required to register
annually, but are not required to list. In addition, contract manufactures and contact
sterilizers (establishments that sterilize or otherwise make a device for a specification
developer or any other person) must also now list at the time of their annual registration.
所有公司只有一个例外-进口商.以前它不仅需要每年注册，同时也需要列出所有医疗用品名单.现在仅需要每年注册.另外协议（代工）工厂和协议（代工）消毒灭菌厂家都必须每年注册并列出产品名单.

11. How do I submit my Listing information?
我怎样提交我的产品名单信息？
Listing information is submitted at the same time as your annual registration information.
产品列名提交应在提交企业注册的同时:

　1. Complete the electronic annual establishment registration.完成企业注册
2. Review the listings currently on record for your establishment.审核在档案中现存的产品名单
3. Make update as needed.如果需要即可更新
4. You may include multiple proprietary names for a given listing if applicable.如果必要你可以给予列名包括多种专有产品的名称
5. For each listing, you will need to identify whether your product requires

premarket notification/approval or is exempt.对于每种列名，你都需要确认这种产品是否有入市前通告或可以豁免
If your product requires premarket notification/approval you will:如果你的产品需要入市前通告你应该
a.Enter the premarket submission number 提交入市前号码
b.Enter the proprietary names 提交产品名称
c.Identify the activities that you perform on or to the products 确认有效性

If your product is exempt you will: 如果你的产品是被豁免的，你应该
a. Identify the product code(s) 确认产品的号码
b. Enter the proprietary names 提交产品的名称
c. Identify the activities that you perform on or to the products确认有效性

12. When will I be able to update my listing information?
何时我将更新我的产品列名？
You will be able to update your listings using the electronic system at ant time, including
when a new device is being produced or if there is a change to device already listed.
你可以在任何时候更新你的产品列名.包括正在生产中的新产品或在列表中已经改变了的产品.

13 Are there any reductions in fees for small businesses or other group?
对于企业或其他团体是否可以减少收费？
No, all establishments who are required to pay have the same establishment registration User fee.
不能，所有被要求付费的企业都必须付相同的注册费.

14. I do not have access to the Internet. How can I submit my annual registration and listing?
我无法上网我如何提交我的年度企业注册和产品列名？
The law requires that all registration and listing be submitted electronically unless FDA
grants you a waiver “because electronic registration and listing is not reasonable for the
person requesting such waiver ”. To apply for a waiver, please submit your request with a
complete explanation of why you cannot submit your registration through the Internet to:
Food and Drug Administration
法律规定全部注册和列名都必须以电子方式提交除非FDA同意你豁免。豁免申请，请写明理由并解释为什么你不能通过网上提交注册.寄到
Center for Devices and Radiological Health, HFZ-308
9200 Corporate Boulevard
Rockville, MD 20850-4015

15. Where can I get assistance of I have any questions?
如果有任何问题，在哪里可获得协助？
For assistance you may contact us at:您可以通过以下方式联系我们：
Email: device.reg@fda.hhs.gov?
电子邮件：device.reg@fda.hhs.gov
Phone: 240-276-0110
电话：240-276-0110
Or You may also contact the Division of Small Manufactures, International and Consumer
Assistance at:
或者你也可以联络小企业国际和消费者协助部
Email: dsmica@fda.hhs.gov
电子信箱：dsmica@fda.hhs.gov
Phone: 240-276-3150 or 800-638-2041
电话：240-276-3150? 800-638-2041

Fees*（注册费）
Congress authorized FDA to collect an annual establishment registration fee for device establishment registrations submitted to the FDA after September 30th, 2007. 国会授权美国食品和药物管理局收取每年设立登记费为器械设立登记，在2007年9月30日后提交给FDA。
The following types of establishments are required to pay the annual establishment registration fee: 下列类型的机构，须每年支付住册登记费

　　·Device manufacturers医疗用品生产企业
·Contract sterilizers (establishments that sterilize a device for a specification 　　　developer or any other person) that put the device into commercial distribution协议消　　　毒灭菌企业（为特定研发者和任何个人的医疗用品的灭菌消毒的企业），把该医疗用品投入批量生　　　产.
·Contract manufacturers (establishments that make a device for specification developer 　　　or any other person) that put the device into commercial distribution协议生产企业（为　　　特定研发者和任何个人制造医疗用品的企业），把该医疗用品投入批量生产.
·Single-use device reprocessors 单一使用医疗用品再制造公司
·Specification developers. 特殊产品的研发公司

Congress has established a schedule of registration fees for fiscal years as follows: 国会已经建立了一个财政年度注册登记费用的时间表如下

提示各企业（公司）注意：所有2008年度的注册都必须在2007年10月1日至2007年12月31日之间完成
There are no reductions in annual establishment registration fees for small businesses or any other group.
小型企业或任何其他团体的年企业注册费不能减少
The fee should be paid as soon as possible after registering your establishment or submitting your annual establishment registration information electronically. Follow the instructions on the screen to make your payment. Be sure to allow for enough time for your payment to be received and recorded. This process can take up to two weeks. Your registration is not complete until FDA notifies you that all requirements have been met.

交费要在公司注册后马上办理。如果只注册不交费，注册将无法完成。您可以按照后续屏幕上的指示操作来付款. 收到您的付款并记录在案需要一定的时间，这个过程可能需要长达两周。交费后两个星期左右，FDA将正式通知企业.

Please note: If you are sending your payment and require a SWIFT code, the SWIFT code for the receiving bank is FRNYUS33.
请注意：如果支付时需要SWIFT代码，收款银行的代码为FRNYUS33
For wire transfer of funds, the required information is:
电汇资金所需的资料：

FDA’s Account number: 75060099
Routing Number: 021030004
Reference: Invoice Number
FDA的账户号码： 75060099
通信号码： 021030004
参考：发票编号
如果支付时需要SWIFT代码，收款银行的代码为FRNYUS33

银行地址
The bank address is:
US Dept of Treasury
TREAS NYC
33 Liberty St
New York, NY 10045
Fed Wire funds are payable in US dollars only. Fed Wire transfers are being made to the US Dept of Treasury’s account at the New York Federal Reserve Bank.
美联储电汇资金只可缴付美元。并通过纽约联邦储备银行付给美国财政部。

Updated October 11, 2007