Recently I had an auditing experience where a firm simply did not include any FDA Adverse Event Codes in their Form 3500A. I was actually surprised the eSubmitter did not "kick" the form out as incomplete. None-the-less, for all those who use FDA Adverse Event Codes when submitting eMDRs, please know
FDA is harmonizing the eMDR adverse event coding system with the new IMDRF Adverse Event Reporting terminologies. Update takes place on April 6, 2018.
Coding Resources
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| Coding Resources |
| This page contains a comprehensive set of resources for reporters to use when selecting event codes in an MDR. |
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John Beasley RAC
Founder and Senior Consultant
Medtech Review, LLC
Henderson NV
United States
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