全国咨询热线：1585-1991-892(江苏);1565-6919-600(安徽);15376481036(山东)
全国咨询热线：
1585-1991-892(江苏);1565-6919-600(安徽);15376481036(山东)
1585-1991-892(江苏);1565-6919-600(安徽);15376481036(山东)
The enterprises produce electronic emission products should submit annual reports of the emission products to FDA between July 1st to August 30th every year to avoid troubles during customs clearance.
During the reports submitting process, FDA needs a signed appointment agreement, Jiangsu Weixin Testing & Services Co., Ltd. can provide agent service of USA.
After registration, no certificate for FDA, there would be one confirmation letter sent from FDA as following (for reference only):
- - - - - - - - - - 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
