激光FDA注册

新闻来源:小编发布时间:2020-11-09 16:14:57浏览次数:299

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,江苏维新检测技术服务有限公司可提供相应的美国代理人服务。
FDA注册后并无任何证书颁发,由FDA发出的确认信内容如下(仅供参考):
- - - - - - - - - - DOCUMENT RECEIVED, FILED, & ACKNOWLEDGED - - - - - - - - - -
This automated notification from the CeSub Submission Process contains general information about the aforementioned submission:

Accession Number: 1331XXX-XXX
Date Loaded: 11/25/20XX
Document Date: 11/21/20XX
Establishment Name: XXXXXXXX
Purpose: This submission is a(n) Annual Report. These Material Processing Laser Products cover the period from July 01, 2012 to June 30, 20XX.

Submitter: Wallace Xu
Email: wallace.xu@zuoce.org
Reporting Official: xxxxx
Email: xxxx
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
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
Thank you for your participation in the eSubmitter Program. If any questions or concerns arise during our review of your report, we will notify you. If you have any questions, contact us at (301) 796-5710.
Sincerely Yours,

Janine M. Morris
Director
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health