辐射激光产品美国FDA
美国FDA规定，任何包含有电路并且发射出任何种类射线的产品都属于电子放射产品。例如诊断用X射线系统、激光手术器械，微波炉及手机等。而X射线、微波、 无线电波（调频RF）、激光、可见光、声波、超声以及紫外线等都属于由电子放射产品放射出的射线，含有这些射线的产品均需向美国FDA递交年度注册。
美国食品药品监督管理局下属的器械与辐射健康中心(CDRH)负责监管在美国市场使用的电子放射产品，其目标是避免公众暴露在危险或者不必要的辐射中。法规21 CFR Subpart J, parts 1000–1050包含了FDA针对电子放射产品的射线安全性的规定。所有的电子放射产品的生产商都必须符合该法规中的规定。如果所生产的电子放射产品是用于医学用途（医疗器械）或用于照射或是检测食品，则该产品的生产商除了满足上述的法规之外，还需要满足相应的法规，如放射性医疗器械产品要进行医疗器械注册和列名等(参看医疗器械FDA认证)。
如果您的产品属于电子放射产品，首次进入美国并且进行商业分销前，必须向CDRH提交产品报告、补充报告或者是缩略报告，以获得跟踪编号（ACCESSION NUMBER）。
我们的服务：
重要提示：
电子放射产品及生产企业在向FDA注册后，将收到由FDA发出的确认信，确认信表明产品和企业的相关报告已经收到，确认信中包含跟踪编号( ACCESSION NUMBER ),此时可以该产品即可在美国市场清关和销售。生产电子放射产品的企业应在每年7月1日至8月30日之间向FDA递交放射产品年度报告，以避免清关受到阻碍。 FDA报告递交过程中需要签署FDA代表指派协议，欧华检测可提供相应的美国代理人服务关于欧华
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l 合作的国内激光雕刻/切割/打标机/激光笔 等生产及外贸企业达到一百多家；
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您完成FDA注册后，您将收到来自FDA的注册确认信，我方也将为通过注册确认的客户出具FDA证书。(下页为FDA注册信样本)
- - - - - - - - - - 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
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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
业务经理