FDA electronic submission gateway (ESG): FAILED eMDR Submission

srrbell

Starting to get Involved
#1
Hi Everyone,

I'm hoping someone might be able to help me deal with an eMDR submission failure that was noticed too late...

I've been using FDA'S ESG to electronically submit MDRs for a couple years now and am familiar with the process. Unfortunately, as we're a small company with limited reports coming in or going out, no one else in the company is really up to speed.

When I was out of the office for a week back in March, my coworker tried to file an MDR electronically (which was actually the addition of a manufacturer narrative in response to a user facility-generated MedWatch report). She did "package" the report using the FDA's eSubmitter software, but she never logged into the gateway (ESG) online to formally submit it. So as far as the FDA is concerned, the MDR was never actually filed. There was another issue similar to this, where the report WAS submitted through ESG, but the "acknowledgments" weren't reviewed carefully... come to find out, the submission actually failed, and now we're past the 30-day deadline. :frust:

Has anyone ever had any experience with these types of problems? (I know it's highly unlikely, but) is there any way to explain these errors/oversights to the FDA so we can correct this problem and/or file late without being penalized?

Thank you for taking the time to read this; any help or experience you can offer would be greatly appreciated! :thanx:
 
Elsmar Forum Sponsor
#4
I've been trying to activate my ESG account for 2 months now! absolutely horrible experience, either they want you to report or not. I've had to get documents notarised and electronic certificates especially created its crazy, but I could get a 483 for not doing it, and on top of it I have to perform a mock EMDR!:frust:
 
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