Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Has anyone been asked to confirm a meeting date BEFORE the RTA part of the process has been completed?  A recent pre-sub request resulted in a quick reply to schedule the meeting, while telling us that the RTA feedback would be provided when the date of the meeting was confirmed.  Perhaps there is nothing needed from the RTA review, but why wait to provide that?  If there is additional information needed per the RTA review, there is little time to get that info to FDA.

I am confused...

Sorry also a bit confused by your post ... are you talking about a 510(k) submission, an IDE submission, an IND submission, or something else?  I am assuming that RTA means Refuse To Accept, but you requested a pre-sub meeting at the same time as the application.  Maybe you could describe the chronology and type of submissions you are doing.

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs
------------------------------

Original Message:
Sent: 25-Jun-2018 08:22
From: Anonymous Member
Subject: Odd pre-sub process

This message was posted by a user wishing to remain anonymous

Has anyone been asked to confirm a meeting date BEFORE the RTA part of the process has been completed?  A recent pre-sub request resulted in a quick reply to schedule the meeting, while telling us that the RTA feedback would be provided when the date of the meeting was confirmed.  Perhaps there is nothing needed from the RTA review, but why wait to provide that?  If there is additional information needed per the RTA review, there is little time to get that info to FDA.

I am confused...

This message was posted by a user wishing to remain anonymous

It was a pre-sub process.  It just seemed that setting up the date of the meeting before accepting the request was out of the usual sequence.
Original Message:
Sent: 26-Jun-2018 03:19
From: Richard Vincins
Subject: Odd pre-sub process

Sorry also a bit confused by your post ... are you talking about a 510(k) submission, an IDE submission, an IND submission, or something else?  I am assuming that RTA means Refuse To Accept, but you requested a pre-sub meeting at the same time as the application.  Maybe you could describe the chronology and type of submissions you are doing.

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs

Original Message:
Sent: 25-Jun-2018 08:22
From: Anonymous Member
Subject: Odd pre-sub process

This message was posted by a user wishing to remain anonymous

Has anyone been asked to confirm a meeting date BEFORE the RTA part of the process has been completed?  A recent pre-sub request resulted in a quick reply to schedule the meeting, while telling us that the RTA feedback would be provided when the date of the meeting was confirmed.  Perhaps there is nothing needed from the RTA review, but why wait to provide that?  If there is additional information needed per the RTA review, there is little time to get that info to FDA.

I am confused...

I've had that happen a couple times. I think the lead reviewers know that calendars are challenging, and they want to ensure they have a timely meeting, so they just get started on that scheduling as quickly as possible. I always choose to view it as the RTA review is likely fine at least based on their first pass.

G-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 25-Jun-2018 08:22
From: Anonymous Member
Subject: Odd pre-sub process

This message was posted by a user wishing to remain anonymous

Has anyone been asked to confirm a meeting date BEFORE the RTA part of the process has been completed?  A recent pre-sub request resulted in a quick reply to schedule the meeting, while telling us that the RTA feedback would be provided when the date of the meeting was confirmed.  Perhaps there is nothing needed from the RTA review, but why wait to provide that?  If there is additional information needed per the RTA review, there is little time to get that info to FDA.

I am confused...