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How to Submit FDA Requested H10 Data on MedWatch FORM 3500A Device Reoprt (Doc ID 3039726.1)

Last updated on SEPTEMBER 23, 2024

Applies to:

Oracle Life Sciences Argus Safety - Version 8.2.3.1 and later
Oracle Life Sciences Argus Safety Cloud Service - Version 8.2.3.1 and later
Information in this document applies to any platform.






Goal

When trying to generate MedWatch FORM 3500A Device report using Argus 8.2.3.1, the FDA required H10 field corresponds to Narrative and not the Related Report Number.

How can the appropriate H10 field data be reported to the FDA? 

Solution

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In this Document
Goal
Solution

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