电子辐射产品美国FDA注册

POST TIME:2019-09-11 14:33 READ:

电子辐射产品美国FDA
  美国FDA规定任何含有电路并发射任何类型辐射的产品都是电子辐射产品。例如,诊断X射线系统,激光手术器械,微波炉和移动电话。 X射线,微波,无线电波(FM),激光,可见光,声波,超声波和紫外线都是电子辐射产品发出的光线。含有这些射线的产品需要提交给美国FDA进行年度注册。美国食品和药物管理局的器械和辐射健康中心(CDRH)负责监管美国市场上使用的电子辐射产品,目的是避免公众接触危险或不必要的辐射。法规21 CFR子部分J,部分1000-1050包含FDA关于电子辐射产品辐射安全的规定。所有电子辐射产品制造商都必须遵守这些规定。如果生产的电子辐射产品用于医疗用途(医疗设备)或用于辐射或用于测试食品,则产品的制造商必须符合上述规定之外的相关规定,例如放射性医疗设备。产品应在医疗器械上注册和列出(参见FDA医疗器械认证)。
  如果您的产品是电子放射性产品,您必须先向CDRH提交产品报告,补充报告或缩写报告,以便在首次进入美国并进行商业销售之前获取跟踪号(ACCESSION NUMBER)。
  我们的服务:
  完成电子排放产品报告并提交给FDA,以帮助您获取跟踪号码(ACCESSION NUMBER),以帮助公司尽快完成,如有必要,如何避免不愿意支付提供美国代理商的费用注册所需
  重要提示:
  在向FDA注册后,电子放射产品和制造公司将收到FDA的确认函,确认已收到产品和公司相关报告。确认函包含跟踪号码(ACCESSION NUMBER)。产品可以在美国市场上清理和销售。生产电子放射性产品的公司应每年7月1日至8月30日向FDA提交放射性产品年度报告,以避免通关障碍。 FDA报告要求在提交过程中签署FDA代表转让协议,AUA测试提供相应的美国代理服务。
  关于欧华
  l国内领先的激光产品FDA注册咨询服务;
  l与国内激光雕刻/切割/打标机/激光笔等生产和外贸企业合作达100多家;
  我快!好服务!职业!焦点!浓缩!
  如果您认为将来可以使用我们的服务,您可以联系我们的在线客服:
  完成FDA注册后,您将收到FDA的注册确认函,我们还将为注册确认的客户颁发FDA证书。


以下为FDA注册确认信样本

- - - - - - - - - - DOCUMENT RECEIVED, FILED, & ACKNOWLEDGED - - - - - - - - - -

- DOCUMENT RECEIVED, FILED, & ACKNOWLEDGED - - - - - - - - - -

This automated notification from the CeSub Submission Process contains general information about the aforementioned submission:

Accession Number:  1820833-000

Date Loaded:  Sep 17, 2018

Document Date:  Sep 15, 2018

Establishment Name:  DONGGUAN HELLEN ELECTRONIC TECHNOLOGY CO.,LTD

Purpose:  This submission is a(n) Product Report. These Surveying, Leveling, Alignment Laser Products include designated model(s) HL-2165-01, HL-2165-02, HL-2165-03, HL-2165, HL-2165P.

 

Submitter: Tony Mo

Email:  tonymo1@cct-prc.com

Reporting Official:  Tony Mo

Email:  tonymo1@cct-prc.com

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

Please note that your firm is required to submit an Annual Report to CDRH every year by September 1.

If you meet all other applicable FDA requirements, you may market the product(s) reported. Please be aware that additional electronic product radiation control or medical device regulations may apply to your product, such as:

 

21 CFR 1002.11, requiring report supplements under certain circumstances following the same reporting forms as used for product reports on your products

21 CFR 1002.13, requiring annual reports to be submitted each year by September 1 using the appropriate reporting form for annual reports

21 CFR 1010 - 1050, requiring certification to FDA radiation safety performance standards

21 CFR 807, requiring manufacturer registration and device listing, and

21 CFR 807, 812 and 814, requiring medical device clearance or approval

 

For further information see:

Radiological Health web site - http://www.fda.gov/Radiation-EmittingProducts/default.htm
FDA Electronic Submissions Gateway website -
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm

If you have any questions, please contact the Director of the Division of Radiological Health, or the branch chief of your respective product area, as listed on the CDRH Management Directory, under the Office of In Vitro Diagnostics and Radiological Health, Division of Radiological Health.
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm127854.htm

Please include a primary (and optional secondary) contact email address in all submissions (and/or cover letters) to facilitate electronic correspondence.

Sincerely yours,

 

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

Center for Devices and Radiological Health


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