Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All.

All being well, I will hopefully submit my first 510(k) application soon. I have installed the eSubmitter tool so I can package the files correctly and I was wondering how long this would take once I hit the 'Package Submission Files'? I used this for one of our pre-submission meetings and it was fairly quick, I am going to guess that the full submission will not be as quick!

In your experience, will this be a few minutes or a few hours for the tool to package the files?

Thanks

Also just a few minutes ... it does not take that long.  Though it does depend on how many files there are - if you have put together all the files according to eCopy specification, then it should result back to you fairly quickly with a positive result !

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 30-Jan-2020 10:10
From: Anonymous Member
Subject: eSubmitter Tool

This message was posted by a user wishing to remain anonymous

Hi All.

All being well, I will hopefully submit my first 510(k) application soon. I have installed the eSubmitter tool so I can package the files correctly and I was wondering how long this would take once I hit the 'Package Submission Files'? I used this for one of our pre-submission meetings and it was fairly quick, I am going to guess that the full submission will not be as quick!

In your experience, will this be a few minutes or a few hours for the tool to package the files?

Thanks

This message was posted by a user wishing to remain anonymous

A couple minutes.

Keep in mind, all it is doing is renaming the files to the correct format and assigning it to a directory. It's not really changing the files.
Original Message:
Sent: 30-Jan-2020 10:10
From: Anonymous Member
Subject: eSubmitter Tool

This message was posted by a user wishing to remain anonymous

Hi All.

All being well, I will hopefully submit my first 510(k) application soon. I have installed the eSubmitter tool so I can package the files correctly and I was wondering how long this would take once I hit the 'Package Submission Files'? I used this for one of our pre-submission meetings and it was fairly quick, I am going to guess that the full submission will not be as quick!

In your experience, will this be a few minutes or a few hours for the tool to package the files?

Thanks

When I opened a file to organize a 510(k) I got a message that said it was only for Quick Review Pilot users and it could only be used as a template. It said if I wasn't with the Quick Review Pilot that my 510(k) would be rejected.

Has anyone else tried this?

------------------------------
John Minier RAC
Consultant, Principal
------------------------------

Original Message:
Sent: 31-Jan-2020 07:17
From: Anonymous Member
Subject: eSubmitter Tool

This message was posted by a user wishing to remain anonymous

A couple minutes.

Keep in mind, all it is doing is renaming the files to the correct format and assigning it to a directory. It's not really changing the files.
Original Message:
Sent: 30-Jan-2020 10:10
From: Anonymous Member
Subject: eSubmitter Tool

This message was posted by a user wishing to remain anonymous

Hi All.

All being well, I will hopefully submit my first 510(k) application soon. I have installed the eSubmitter tool so I can package the files correctly and I was wondering how long this would take once I hit the 'Package Submission Files'? I used this for one of our pre-submission meetings and it was fairly quick, I am going to guess that the full submission will not be as quick!

In your experience, will this be a few minutes or a few hours for the tool to package the files?

Thanks

This message was posted by a user wishing to remain anonymous

My experience is a couple minutes.
Original Message:
Sent: 15-May-2020 13:18
From: John Minier
Subject: eSubmitter Tool

When I opened a file to organize a 510(k) I got a message that said it was only for Quick Review Pilot users and it could only be used as a template. It said if I wasn't with the Quick Review Pilot that my 510(k) would be rejected.

Has anyone else tried this?

------------------------------
John Minier RAC
Consultant, Principal

Original Message:
Sent: 31-Jan-2020 07:17
From: Anonymous Member
Subject: eSubmitter Tool

This message was posted by a user wishing to remain anonymous

A couple minutes.

Keep in mind, all it is doing is renaming the files to the correct format and assigning it to a directory. It's not really changing the files.
Original Message:
Sent: 30-Jan-2020 10:10
From: Anonymous Member
Subject: eSubmitter Tool

This message was posted by a user wishing to remain anonymous

Hi All.

All being well, I will hopefully submit my first 510(k) application soon. I have installed the eSubmitter tool so I can package the files correctly and I was wondering how long this would take once I hit the 'Package Submission Files'? I used this for one of our pre-submission meetings and it was fairly quick, I am going to guess that the full submission will not be as quick!

In your experience, will this be a few minutes or a few hours for the tool to package the files?

Thanks