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Siebel Life Sciences Guide > Regulatory Reporting > Transmitting Electronic Medical Device Reporting ImmediatelyOccasionally, 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
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. |
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