The FDA ESG website provides notification of scheduled maintenance and maintains a status history that documents unscheduled down time for the FDA ESG. The CDRH eMDR website provides notification of scheduled maintenance for the CDRH eMDR processing system. Typically, an ESG or CDRH eMDR processing system outage will not last more than 24 hours and should not require an extension of time. However, if a manufacturer or importer is unable to submit a report on time due to an outage affecting the ESG or the CDRH eMDR processing system, it may document its attempts at timely filing in Block H10 for the affected reports and submit reports electronically as soon as the ESG or CDRH eMDR processing system is operational.
A reporting entity using an HL7 reporting option should plan for a backup method of reporting for an outage affecting its own system. If a reporting entity experiences an outage within its own system that will affect timely reporting, it should contact FDA at the eMDR email address, eMDR@fda.hhs.gov. The email should provide FDA with information on the problem, the number of reports affected, and an estimate of how long it will take to resolve. We will respond to provide instructions on alternatives for submission of the adverse event reports. A description of the problem with the electronic submission should be documented in Block H10 for the affected reports before they are submitted.
When an alternative method is used during a system outage, FDA will respond with an Acknowledgment 3 that documents that the report has been successfully loaded in the CDRH database or failed to load due to specified errors. In these instances, the reporting entity will not receive an Acknowledgment 1 or 2.
