FDA’s system will automatically route three separate electronic acknowledgments to the user’s ESG account. These acknowledgements indicate the stage of processing that the eMDR has reached:
- Acknowledgment 1, also known as the Receipt or MDN (Message Disposition Notification) acknowledgment, indicates that the ESG received the eMDR(s).
- Acknowledgment 2 indicates that CDRH received the eMDR(s).
- Acknowledgment 3 indicates the pass or failure status of the eMDR(s) into CDRH’s adverse event database–that is, whether the eMDR was successfully loaded into the database.
If there are no errors, we anticipate that the three acknowledgement letters will be generated the same day or within 24 hours of the submission.
