CDRH portal/change in contact person
- Thread starter SallyOV
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I'm curious myself... years ago, I was nearly certain that the answer was effectively no. This seems absurd, but I was at a company where the point person for "portal reasons" was the point of contact for all sorts of stuff... and she was approaching retirement, so issues involving UDI, Reporting, etc. were all going to be jeopardized. We never resolved this (while I was there) but I remember having to drag her back into communicating with an agency because she was the only person who could send/get emails.
I doubt anyone considers this when establishing contact, but a "generic" company mailbox really should be used for these sorts of agency contacts. It is far easier for a company to reassign its own mailbox than it is to get federal agencies to do the necessary updates... certainly on the typical timescale of employment at medical device manufacturers.
I doubt anyone considers this when establishing contact, but a "generic" company mailbox really should be used for these sorts of agency contacts. It is far easier for a company to reassign its own mailbox than it is to get federal agencies to do the necessary updates... certainly on the typical timescale of employment at medical device manufacturers.
EmiliaBedelia
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IIRC, anyone can make an account for the CDRH submission portal, so if you don't have an ongoing submission going on I would just create an account for the new person. There's not really a need to change the contact person IMO. Last time I used it the portal is kind of useless for managing a submission anyway because it just tells you the status and the number of days. You should have a means other than the submission portal for managing the eCopy and correspondence regardless.
To change the official correspondent for an ongoing submission, in the past you had to send a letter/memo to the reviewer. If you are trying to change the official correspondent, I would also reach out to the reviewer to make sure that they change the person on record.
To change the official correspondent for an ongoing submission, in the past you had to send a letter/memo to the reviewer. If you are trying to change the official correspondent, I would also reach out to the reviewer to make sure that they change the person on record.
As I wrote, for me this was many years ago, but the issue we were having was that the single user and site/company ID (for submissions) had a 1:1 relationship. At that time, creating a new account would have ended up with a new number. I always assumed that enough phone calls could get it straightened out, but that it wouldn't necessarily be quick.
The times I got dragged into this were pretty much textbook "poor planning on your part..." situations with a healthy dose of "oh, are these the consequences of my actions?"
EmiliaBedelia
Trusted Information Resource
I think you might be thinking of FURLS and the industry systems accounts. That system is also a nightmare, but at least it's easy to update the official correspondent. In addition to DRLM/FURLS there are a lot of secret systems/databases that are not obvious and also not linked to any other systems, so there are certainly places where an email address can hide and cause big problems. FDA has moved over to 2FA recently anyway so the days of 1 shared account across an entire division are coming to an end.
The CDRH portal is pretty new - it is basically a submission portal only and was only implemented around the time they started accepting eSTARs. It is not connected to the industry systems for establishment registration, etc.
Ahh yes. I enter the credentials listed on our internal cheat sheet. But wait! An email has been sent to W******@companyname.com. They have a code that lasts 10 minutes. Oh...I have to call this person, tell them they've received an email with a super secret code. Send me the code in (looks at clock).... 7 minutes!
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