I am experiencing an error in WebTrader

Email the ESG HelpDesk at [email protected] and request support

I am experiencing an error in eSubmitter

Email the eSubmitter Helpdesk at [email protected] and request support

Ack3 says my report failed due to a "duplicate report" error

This error means that eMDR has already accepted a report with this report number. If this is a supplemental report, verify that it is marked as a follow-up and has the correct follow-up number. If you are submitting to pre-production, note that pre-production may contain reports received in production or from paper submissions. Pre-production eMDR submissions should always have report numbers that have never been used before on any MDR.

I am a high-volume submitter and I get the "duplicate report" error on the first submission of a report

Email the CDRH Electronic Submissions Helpdesk at [email protected] and request that they look up the core ID for the report with the report number in question. Your AS2 system may have sent the same report twice, or there could be some other technical issue.

Ack3 says my report failed due to having an invalid report number

This error means that the report number you provided was not valid. Every report (even reports to the pre-production system) must include a current and valid FEI or CFN number in the first part of the report number. The pre-production eMDR system will also reject reports with very high years (ex. 9000). The sequence number in the final part of the report number should always have five digits, and the first report of each year should have sequence number 00001.

How do I sign up for ESG or eMDR?

Go to the eMDR Enrollment site to sign up.

How long is the process to receive a new ESG account and enroll in eMDR?

Receiving a new ESG account and enrolling as a low-volume eMDR submitter takes approximately one to two weeks. High-volume enrollment requires approximately one additional week to validate the final test submissions.

Am I required to report this event?

Email the MDR Policy Branch [email protected] with your question

How do I submit electronic reports other than MDRs to CDRH? Ex. ISO 13485

Email the CeSub Helpdesk at [email protected] and request information about the submission type in question

How do I submit electronic reports regarding drug adverse events?

Email the CDER Electronic Submissions Helpdesk at [email protected] and request information about drug adverse event reporting

I received a letter informing me that a voluntary MedWatch report involving one of my firm's devices was received. Can I get the voluntary reporter's contact information in order to follow-up?

The copy of the report that was sent provides all of the information that the FDA is allowed to release about the report in question. Please be aware that voluntary submitters can request that they not be identified to the device manufacturer. In either case, the copy of the report you received contains all of the releasable information.

How is the eMDR project related to the FDA ESG?

All electronic submissions to the FDA come through the ESG. You should purchase a digital certificate and register as a trading partner with the FDA. Once registered, you can submit electronic MDRs via the ESG. See more about ESG.

How will we know our submission reached CDRH?

You will get three acknowledgments when you submit your MDR electronically. Acknowledgment 1 (also referred to as Receipt) is sent by the ESG and confirms the submission was successfully received by the ESG. Acknowledgment 2 is sent by the ESG and indicates the submission reached CDRH. Acknowledgment 3 is sent from CDRH and indicates your submission is successfully loaded or notifies you of any errors that occurred during validation and loading. Your "passed" Ack3 serves as proof that your submission was received and accepted by eMDR.

What is the time frame to receive these acknowledgments?

You should receive your acknowledgments quickly after your submission unless ESG is down for maintenance. If the ESG is down, acknowledgments 1 and 2 will be delayed. If the eMDR system is down, acknowledgment 3 will be delayed.

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. For example, a filename such as "5555555555.5555.5555.xml" will be read as filename "5555555555.55555555xml." This will result in the FDA being unable to open and read the file properly, so please only include periods in a filename to indicate file extensions.

Will requests for additional information from CDRH come to us via the ESG electronically?

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.

What data can we use for testing?

All test reports are loaded to our test database. These reports will not be released to the public at any time. You can submit "made-up" data for testing or use data from a prior 3500A. 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. Example -- CFN-YEAR-70001 or FEI/CMS-YEAR-70001.

How do I sign up to receive alerts about eMDR and other CDRH electronic submissions systems?

Sign up for the CDRH Industry email list