A bit long winded but here's some background: Last year there were some branches that acted as the guinea pigs to try the interactive RTA process and I now believe it is in practice for all branches. David's right that there was some criticism that reviewers were RTA'ing (sometimes on day 15) things that were very easy to remedy (e.g. the file says "see label on page ##" and the sponsor forgot to include the label in an attachment). In this example, if asked, the sponsor could easily send the attachment and the file could be accepted. But instead they were refused and went back to Day 1, [do not pass GO, do not collect $200]. Once they finally got the necessary documentation in, then they would be accepted. Interactive RTA was FDA's way to compromise a bit...if the items could be easily sent, then the reviewer should keep it on FDA's clock and work interactively. If large swaths of items were missing from a submission, the reviewer should refuse it and wait until the sponsor got it right.
I heard of some consultants/companies complaining that their files were refused over and over by the lead reviewer, allowing the clock to be reset over and over. This is not the point of the RTA since when you send in your response to a refusal, you're now saying "I believe I am sending you what you've asked for." Unless it's still glaringly deficient, it should be accepted. While I like to think that the reviewers are trying hard to accept files that are complete, it was being seen by industry as a way of FDA adding more time to their clock without taking a hit on the MDUFA goals. And some reviewers were refusing over and over, sometimes for new issues (which is wrong and supremely frustrating). Again, not my files, but still... :)
With all this said, these questions should not be SR questions/deficiencies. If you think it's more along the lines of SR instead of RTA, I would talk to the lead reviewer about that (and maybe the branch chief if you think you need to). Every 510(k) needs to stand on it's own, however, if you're asked for software documentation and you've indicated that it is identical to K###### (your own company's predicate), then I would say you should not have to include this again. Make sure that you've included that this device/system is part of a previous submission and include the K-numbers (there is a place for this as well in the CDRH coversheet). If they just want you to include it all over again when you're just adding to that previously cleared system, I would consider that burdensome and would ask the reviewer why.
The new guidance (issued 8/4/15) recommends you not only include the complete RTA checklist but also include the page numbers were everything can be found. This helps them accept it faster if they choose to use it. And the person doing the RTA is almost always your lead reviewer. I've only known a few rare occasions where this is not the case.
Good luck!
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Allison Komiyama PHD, RAC
Principal Consultant
Acknowledge Regulatory Strategies
San Diego CA
United States
Original Message:
Sent: 01-18-2016 15:06
From: Tina O'Brien
Subject: RTA vs. Substantive Review
One more question on this topic... Is it likely that the person conducing the RTA review is also the SR reviewer?
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Tina O'Brien RAC, MS
Sr. Regulatory Affairs Specialist
Fisher & Payket Healthcare
Auckland
New Zealand