Form FDA 3500A MedWatch eSubmitter

gunnyshore

gunnyshore

Starting to get Involved
#1
#1
I'm about to embark on this project to setup the Electronic Submissions Gateway so that I can submit MedWatch reports.
Has anyone gone through this gauntlet and has any recommendations, things not to do?

Thanks for your help - Jim Shore
 
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William55401

William55401

Quite Involved in Discussions
#2
#2
Here's an option to consider. Don't do it. I was in a similar place as you. For a past consulting client (class I sterile consumer direct), I had a service supplier (Registrar Corp) take on the Registration and Listing (R & L) responsibilities for the client. As part of the R & L services, the supplier became the firm's official correspondent with USA FDA. eMDR submissions (form 3500A) was included in the base services cost. This made sense for my client as we expected a handful of MDRs per year. Disclaimer: I am an independent consultant and not affiliated with Registrar Corp.
 
gunnyshore

gunnyshore

Starting to get Involved
#3
#3
William55401 said:
Here's an option to consider. Don't do it. I was in a similar place as you. For a past consulting client (class I sterile consumer direct), I had a service supplier (Registrar Corp) take on the Registration and Listing (R & L) responsibilities for the client. As part of the R & L services, the supplier became the firm's official correspondent with USA FDA. eMDR submissions (form 3500A) was included in the base services cost. This made sense for my client as we expected a handful of MDRs per year. Disclaimer: I am an independent consultant and not affiliated with Registrar Corp.
Click to expand...
 
William55401

William55401

Quite Involved in Discussions
#5
#5
You are welcome. Just about everything (with the exception of Management Responsibility) can be outsourced. Good luck.
 
L

lizVR

Registered
#6
#6
gunnyshore said:
I'm about to embark on this project to setup the Electronic Submissions Gateway so that I can submit MedWatch reports.
Has anyone gone through this gauntlet and has any recommendations, things not to do?

Thanks for your help - Jim Shore
Click to expand...
It is kind of a pain getting it all set up, but once you have the software installed and the account activated with CDRH, the individual submissions are quite simple. If you find yourself needing to maintain that path the site has guidance for use and setup.

Go to CDRH learn and Questions and Answers about eMDR - Guidance doc (I don't have enough posts to give you the links, 2 more to go!)
 
P

PercyG

Registered
#7
#7
We are a distributor and received a MedWatch report from a customer due to a quality issue. As a distributor, our only requirement is to forward the report to the manufacturer to complete, correct?
 
L

LUFAN

Involved In Discussions
#8
#8
What does your quality agreement say with the manufacturer? If no agreement or language, you might need to file yourself and still report to manufacturer.
 
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