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Helpful Tips
February 2007 Edition:
Dear CeSub Participant:
This email is one of a series of emails meant to provide you with helpful information regarding the CeSub eSubmitter software. These emails will include enhancements in the latest software release, as well as highlight solutions for common problems that users are having with eSubmitter.
Recent updates to the eSubmitter software included the following enhancements:
- Enhanced the file attachment capability to include Excel files (.xls, .csv).
- Updated various business rules and questions within the eSubmitter templates.
- Enhanced the Rad Health related submittal letter (cover letter).
- Incorporated CLIA templates related to OIVD reporting, including a CLIA Waiver template and a CLIA Categorization Request template.
- Note: Periodically, you should connect to the Internet and start up eSubmitter so that the software updates automatically to our latest version.
Don't Forget:
- Package your Submission: Electronic submissions must be correctly packaged within eSubmitter and the zip file should be burned onto a CD-ROM. (Note: Only burn one zip file per CD-ROM.) CDRH will not be able to process submissions that are not correctly packaged. See below for step-by-step instructions on packaging submissions within eSubmitter.
- Cover Letter: Remember to print out a hard copy of your cover letter after you have completed, packaged, and copied your submission onto a CD-ROM. Be sure to sign the cover letter and include it with the CD-ROM that you mail to CDRH. We cannot begin processing your submission without a signed cover letter. Don't forget it is no longer necessary to print the whole report to submit. Only the cover letter needs to be printed and signed (except for any variance requests that must be sent to Dockets Management).
Having Trouble?
- Packaging Submissions: Do you have trouble attaching files to a question in your submission? Read Packaging Submission Files for detailed instructions.
- Expired Report Forms: Have you experienced trouble with your report form expiring before you are ready to submit? Read Expired Report Forms for a detailed explanation and instructions for our current work-around.
- Supplements to Expired Report Forms: Do you open an expired-template report to do a Save As…, and discover that it's not editable? Or open a report to create a supplement, but it expires before you're done? Read Expired Report Forms for help.
Thank you for your continued participation in this program!
The CDRH CeSub Team
July 2006 Edition:
Dear CeSub Participant:
This email is one of a series of emails meant to provide you with helpful information regarding the CeSub eSubmitter software. These emails will include enhancements in the latest software release, as well as highlight solutions for common problems that users are having with eSubmitter.
The new software version 1.11.04 was made available July 6, 2006!
- For more information, click here to visit our website.
- Periodically, you should connect to the Internet and start up eSubmitter so that the software updates automatically to our latest version.
Don't Forget:
- Product Codes: When searching for your product code using the product code search tool, remember that it will only search on one word at a time. Try to search several times, trying different key words, to find the best match for your product.
- Cover Letter: Remember to print out a hard copy of your cover letter (aka Submittal Letter) after you have completed, packaged, and copied your submission onto a CD-ROM. Be sure to sign the cover letter and include it with the CD-ROM that you mail to CDRH. For legality reasons, the FDA requires a signature from the manufacturer representative.
- Email subscription: New subscription list-serve for updates and new guidances on the Radiological Health website. Interested? See www.fda.gov/cdrh/radhealth
Having Trouble?
- File Attachments: Do you have trouble attaching files to a question in your submission? Open the PDF “Attaching_Files” for further instructions.
This information contained in this email is from the CDRH CeSub Team. For specific questions regarding CeSub eSubmitter, email us at cdrhesub@cdrh.fda.gov. Questions regarding FDA regulations or requirements in Radiological Health's performance standards should be directed to the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at dsmica@cdrh.fda.gov or the Division of Mammography Quality and Radiation Programs (DMQRP) at 301-594-3332.
Thank you for your continued participation in this program!
The CDRH CeSub Team
January 2006 Edition:
Dear CeSub Participant:
This email is the first in a regular series that will provide you with helpful information regarding the CeSub eSubmitter software. These emails will include enhancements in the latest software release, as well as highlight solutions for common problems that users are having with eSubmitter.
New in software version 1.10.00 (available January 9, 2006):
- Microwave Oven Products Annual Report is now available!
- For more information, visit our website.
Don’t Forget:
- Periodically, you should connect to the Internet and start up eSubmitter so that the software updates automatically.
- After you complete, package, and copy your submission onto a CD-ROM, be sure to print out a hard copy of your cover letter. Sign the cover letter and include it with the CD-ROM that you mail to CDRH. For legality reasons, the FDA requires a signature from the manufacturer representative.
- Have you sent an electronic Radiological Health submission to CDRH and received an acknowledgement email message with your accession number? Be sure to reopen your submission and add the FDA accession number. (From eSubmitter, open your report, click Tools, Assign Report ID.)
- To attach a file to a particular question, you must perform two distinct steps: 1) You must add the file to your File List. 2) You must then select the specific file to attach it to the question that you are answering. Need more help? See the information below.
Having Trouble?
This information contained in this email is from the CDRH CeSub Team. For specific questions regarding CeSub eSubmitter, email us at cdrhesub@cdrh.fda.gov. Questions regarding FDA regulations or requirements in Radiological Health’s performance standards should be directed to the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at dsmica@cdrh.fda.gov or the Division of Mammography Quality and Radiation Programs (DMQRP) at 240-276-3332.
Thank you for your continued participation in this program!
The CDRH CeSub Team
Updated April 6, 2007 |
