3500a software

Are there any formatting requirements for filenames submitted via eMDR? Please make sure filenames do not contain periods except to indicate the file extension. Due to the way filenames are read, once a period is encountered, the rest of the filename is considered the file extension.

No, at this time the ESG is not set up to handle outgoing requests for additional information. You will receive any request for additional information by mail in keeping with our current practice. Are there any special requirements for digital certificates to submit via the ESG? For questions regarding registration, setup, policy, and so on, please write to esgprep fda. Can we install FDA eSubmitter on a network? The software can be installed anywhere and will work properly.

The file-locking option can be used to prevent users from accidentally overwriting the work of another. We have a PDF we want to include. Do not modify the file after it is generated by FDA eSubmitter. If you do, your submission will fail our loading process.

Repackage your files and resubmit your submission to FDA. Can we submit multiple patients or devices per MDR report? How do we report supplemental or follow-up information? For supplemental information, only submit new or updated information.

Do not resubmit information provided with your initial MDR submission. Make sure you denote the report as a follow-up in Section G7, and provide a follow-up number. New and updated information that can be provided as discrete data elements on the A form should be reported in the appropriate sections. Instead, include it in Section F10 where you would normally provide device problem codes.

How do we do that? Please use field H10 to explain the change or indicate the change for the field. This includes all discrete data elements. Note that this is different from how supplemental reports are submitted refer to question above. You may submit the letter you received as part of the attachment to the message. How do we submit attachments? You can submit attachments electronically using the FDA eSubmitter application.

Depending on the source of the initial report, you may submit the source report information as follows:. If you have more than one source report for the event—that is, both 1 and 2 as described above—include one report as part of your electronic MDR, and submit the other s as attachment s.

How do we go about setting up for testing with the eMDR system? The purpose of testing is to catch any issues early on, so once you transition to electronic reporting, there are no major problems due to improper formatting or incorrect values in the submission.

When you are ready to send a guidance compliant electronic MDR submission, please send the below test reports based on your submission method to the test ESG account.

Can we send test submissions through the Gateway? What data can we use for testing? All test reports are loaded to our test database. This will not be released to the public at any time. To ensure that your report does not get rejected because a duplicate report is present in our system with the same report number, please use a leading 7 in your sequence number. How many reports are required for testing? The purpose of testing is to catch any issues early on, so once you transition to electronic reporting, there are no major problems.

Testing will continue until all issues are resolved satisfactorily. Issues can arise as a result of improper formatting, validation failures, etc. When you are ready to send a guidance compliant electronic MDR submission, please send the below based on your submission method to the test ESG account. Who should we contact with questions? DRAFT v1. By using FDA eSubmitter, participants generate a standard adverse event message effortlessly, without the need for special programming.

Incoming submissions are processed as follows: The ESG receives an inbound submission. Once you package a submission in eSubmitter, you can securely submit it as noted in the table below. The FDA does not have the ability to access, review, or supplement the information on your local computer through this application.

Please note that the method for sending submissions to the FDA differs based on the Center and submission type being transmitted. See the Quick Guide for packaging guidelines for participating eSubmitter Programs. As a user of this software you are not required to perform your own validation.