About FDA Confirmations for Electronic Medical Device Reporting

Once an eMDR or a batch eMDR has been transmitted to the FDA, the FDA Electronic Submissions Gateway (ESG) will respond to the submission. Depending on the processing state, the FDA Status field may be in any of the following three states:

• 1 of 3 - ESG. Indicates that FDA ESG has sent a Message Delivery Notification (MDN) to confirm that the submission was received. The message includes an official date received.

• 2 of 3 - ESG. Indicates that FDA ESG has sent an MDN to confirm that the submission has reached the Center for Devices and Radiological Health (CDRH).

• 3 of 3 - ESG. Indicates that CDRH has sent a message to confirm that the submission has been successfully loaded into the Adverse Event database, or that it has been rejected.

For information about eMDR transmission using Siebel Business Application, refer to Transmitting Electronic Medical Device Reporting Immediately, and Managing Batch Electronic Medical Device Reporting.