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  7. eMDR Frequently Asked Questions (FAQs)
  1. eMDR – Electronic Medical Device Reporting

eMDR Frequently Asked Questions (FAQs)

Update: April 13, 2026

As of April 14, 2025, the ESG NextGen Unified Submission Portal (USP) replaced the legacy WebTrader user interface. This user-friendly web-based platform provides the ability to submit regulatory information to the FDA and track the status through Center receipt. 

This webpage addresses common questions about the preparation and submission of eMDR files. 

Frequently Asked Questions

QuestionAnswer
How do I enroll in ESG NextGen or eMDR?Go to the How to Enroll in eMDR Program webpage for instructions to sign up.
How long does it take to receive a new ESG NextGen account and enroll in eMDR?

Low-volume submitters receiving a new ESG NextGen account and enrolling in eMDR take approximately one to two business days.

High-volume submitters take approximately one due to additional required validation of the final test submissions.

Am I required to report this adverse event?

Refer to the Code of Federal Regulations Title 21 Part 803 (Medical Device Reporting) and Medical Device Reporting for Manufacturers – Guidance for Industry and FDA Staff.

If you have further questions, email the MDR Team’s Helpdesk at MDRTHelpdesk@fda.hhs.gov.

How do I submit electronic reports other than MDRs to the Center for Devices and Radiological Health (CDRH)? Ex. eCopies or Radiation Emitting ProductEmail the CeSub Helpdesk at CeSubHelpDesk@fda.hhs.gov and request information about the submission type in question.
How do I submit electronic reports regarding drug or biologic adverse events?Email the Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER)  Electronic Submissions Helpdesk at esub@fda.hhs.gov and request information about drug adverse event reporting to FDA’s Adverse Event Reporting System (FAERS).
I received a letter informing me that a voluntary MedWatch report (Form FDA 3500 for health professionals or Form 3500B for consumers/patients) 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 you received contains all of the allowable releasable information about the report in question. Please be aware that voluntary submitters can request that they not be identified to the device manufacturer.
How is the eMDR submission process related to the FDA ESG NextGen?    eMDR uses the FDA Electronic Submissions Gateway Next Generation (ESG NextGen), an agency-wide receipt point for sending information electronically to the FDA. Within that context, the FDA ESG NextGen is a conduit, or "highway", along which submissions travel to reach their final destination. You must register for an ESG NextGen account to submit to eMDR. See more about ESG NextGen.
How will we know CDRH received our submission? (For both low- and high-volume submitters).

You will get four separate Acknowledgment files (Ack1, Ack2, Ack3, and Ack4) when you submit your MDR electronically through the ESG NextGen. You must review Ack3 and determine if the MDR “passed” or “failed” to verify that your submission was accepted by eMDR.

Acknowledgment 1 (Ack1) is sent by the ESG NextGen and confirms the submission was successfully received by the ESG NextGen.

Acknowledgment 2 (Ack2) is sent by the ESG NextGen and indicates the submission was sent to CDRH.

Acknowledgment 3 (Ack3) and Acknowlegdement 4 (Ack4) are sent from CDRH. Ack3 is an HTML file, while Ack4  is an XML file, but they contain the same information. Examples of both "passed" and "failed" Ack3 and Ack4 are available in the eMDR implementation Package.

What happens when Ack3 and Ack4 notify me of errors in submissions?If you submit an electronic MDR and you get an error message in Acknowledgment 3 (Ack3) and Acknowledgment 4 (Ack4), please correct the errors and resubmit the submission. When you resubmit the MDR, you will get another set of acknowledgments (Ack1, Ack2, Ack3, and Ack4).
What is the time frame to receive these acknowledgments?You should receive all acknowledgments (Ack1. Ack2, Ack3, and Ack4) within 5-10 minutes after your submission unless ESG NextGen or eMDR is down for maintenance.
Is there a recommended time of day to send submissions?

Maintenance (whether scheduled or unscheduled) should take place over the weekend. For this reason, reporters are asked to submit their reports between the hours of 10:00 a.m.

Monday and 5:00 p.m. Friday (Eastern Time Zone (ET)) (UTC−05:00).

The various systems used to process electronic MDRs are independent of each other with regard to scheduled maintenance and down-times:

The ESG NextGen is down: If the ESG NextGen is down, acknowledgments 1 and 2 (Ack1 and Ack2) will be delayed. Your submission will not reach CDRH for processing using the eMDR system. Refer to the Planned Maintenance and Status History | FDA for information on ESG NextGen maintenance and down-times.

eMDR system is down: If the eMDR system is down,  Acknowledments 3 and 4 (Ack3 and Ack4) will be delayed. If the eMDR system is down, but the ESG NextGen is functional, your submission will be routed to CDRH, and you will receive Ack1 and Ack2. Refer to eMDR System Status | FDA for information on eMDR maintenance and down-times.

How do I submit a supplement/follow-up report?

Your supplement report will have the same report number, but it will be marked as a follow-up in G6 (for manufacturers) or F7 (for user facilities and importers). It will also include a follow-up number, which is 1 for the first supplement, and increments by 1 for each supplement thereafter. If you used eSubmitter to generate the initial report, you may reopen the submission in eSubmitter, update the relevant report fields, update G6/F7 with the appropriate follow-up information, and then repackage and resubmit your report. If you are starting from a blank report, be sure to include the report number from the initial report in the report number field.

Please do not repeat content in the narrative fields, because the supplement's narrative is appended to the original narrative in MAUDE Database. The values you include in other fields will be used to overwrite the corresponding value in the previous version of the report.

Will requests for additional information from CDRH come to us electronically using the ESG NextGen?No. At this time, the ESG NextGen is not set up to handle outgoing requests for additional information. You will receive any request for additional information by email.
What data can we use for testing?

All test reports sent to eMDR Test are loaded to the test MAUDE Database. These reports will not be released to the public at any time. You can submit fictional 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.

Examples:

FEI/CFN-YEAR-70001 (for Manufacturer and Importer reports) CMS-YEAR-7001 (for User Facility reports).

How do I sign up to receive alerts about eMDR and other CDRH electronic submissions systems?You may use the Subscribe to CDRH Email Lists | FDA webpage and enter your email to subscribe to the subscription that best suits your needs.
Who do we contact for questions regarding the FDA ESG NextGen?For questions regarding registration, setup, policy, and other FDA ESG questions, please write to ESGNGSupport@fda.gov.
Can we install FDA eSubmitter on a network?Yes. 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. For details, see Networking in Preferences in the FDA eSubmitter User Manual.
We have a PDF we want to include. Can we add it to the zip file generated by FDA eSubmitter?No. Do not modify the file after it is generated by FDA eSubmitter. If you do, your submission will fail the our loading process. Always attach the desired PDF to the appropriate question using the Attachments section of the 3500A form in FDA eSubmitter software. Repackage your files and resubmit your submission to FDA.
Can we submit multiple patients or devices per MDR report?No. The current version of FDA eSubmitter allows only one patient and one device per MDR report. Each report may have only one Section A and one Section D. The same is true for eMDR submission XML files from high-volume submitters.
How do we submit attachments?You can submit attachments electronically using the 3500A form in the FDA eSubmitter application (for low-volume submitters) and in the eMDR submission XML file (for high-volume submitters). Refer to the FDA eSubmitter User Manual.

If your questions are not answered on this page, please visit the eMDR Troubleshooting and Contacts webpage.

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