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Transmitting Electronic Medical Device Reporting Immediately

Occasionally, you may be made aware of a unique medical device report that cannot wait until month-end processing, and must be reported to the FDA immediately.

For more information about rules and guidelines for regulatory reporting delays, refer http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm149672.htm.

To force immediate FDA reporting

1. Navigate to Regulatory Reports screen, then the eMDR view.

   A list of all regulatory reports whose RR Sub Status is eMDR will be listed.

2. In the eMDR list, select the regulatory report you want to transmit.

   Regulatory reports that have not yet been transmitted will have Transmission Status set to Not Transmitted.

3. Click Transmit.

   NOTE:  The Transmit button will be grayed out if the regulatory report has already been transmitted or has been overridden.

Once transmitted, monitor the FDA Status field of the eMDR for FDA confirmation. For more information on confirmation statuses, refer to About FDA Confirmations for Electronic Medical Device Reporting.