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DIRECTIONS FOR COMPLETING SEAWARD REQUEST FORM (Rev. 8/7/14) SECTION I FUNDS REQUESTED/PERIOD OF PERFORMANCE/BACK-UP DOCUMENTATION CFS Account No: (Do not request Subaward under ANA account or if
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ORA UMD stands for Other Reportable Adverse Events Unanticipated Medical Devise. It is a reporting system used to disclose adverse events related to medical devices.
Manufacturers, importers, and device user facilities are required to file ORA UMD reports when adverse events occur with medical devices.
ORA UMD reports can be filled out online through the FDA's MedWatch website or by submitting a paper form to the FDA.
The purpose of ORA UMD is to ensure the safety and effectiveness of medical devices by reporting and investigating adverse events.
Information such as the type of device, details of the adverse event, patient information, and any actions taken in response to the event must be reported on ORA UMD.
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