510(k) - Finished Test Reports - RTA - Bit of a Complaint

rwend07

Involved In Discussions
#1
Hello all,

We recently submitted a 510(k) citing a consensus standard and following test protocols outlined within the standard. We got an RTA that basically informed us that a new standard had recently published that superseded the previous standard and that we would need to re-do the biocomp testing before being moved into substantive review. In the process of talking with the reviewer, we asked if we could add placeholders for this testing so we could enter substantive while we waited for the test results, to which they said all test reports needed to be finalized before clearing RTA review.

My issue with this process is that it can (and is for us) seriously delaying the regulatory clearance while not having any positive impact on safety of the end user/patient (in fact, delaying the tech is likely costing quite a few lives). Our issue is that we will not receive any feedback on our test results until after our final test reports are issued (10+ weeks, plus RTA review and substantive review time) and will not know if any of our performance testing results are sufficient. This delay is a serious issue for a small startup.

So, in general, why are "placeholders" for final test reports not accepted for getting through RTA review when there is a clear timeline for results? Is this something that has been addressed somewhere within the FDA? Am I missing something here? It just seems like it would be much more efficient to pass it into substantive, review the entire submission, then if everything else is good-to-go, issue a hold so that their review times are not effected.

It'd be great to hear some "more experienced than I" perspective on this to ease my anxiety regarding our 3+ month delay.
 
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JeantheBigone

Quite Involved in Discussions
#2
The purpose of the RTA is to ensure that all information required for the reviewers to begin the substantive review is present. Back in the day, FDA would accept incomplete submissions and then start and stop as results were made available. The resulted in long review times and in some cases wasted effort when the submission was never completed.

Taken to the extreme, if "placeholders" were allowed, it would be possible to submit a 510(k) with no results, only the promise to have them ready at some later date. There would be nothing for FDA to review.

I would ask the question as to whether the consensus standard to which the testing was done was recognized by FDA at the time of submission (or shortly before). If it was not, you can submit either an audit showing the differences between the old and new standard OR a justification for why the older standard was used. That might be enough to get the submission back on track. You might try that tactic while getting the test results ready.

Another option open to you is the Q-sub, if you want to get a feel for what information the reviewers think they need to give you a positive decision.

It can be frustrating, that is for sure. I wish you luck!
 

shimonv

Trusted Information Resource
#3
Hi rwend07,
Which consensus standard are you referring to? and how old are your reports?

I agree with Jeanette. The FDA will not accept "placeholders" because it defeats the whole purpose of the RTA policy. Sorry.
You should defiantly consult with the test lab; perhaps you don't need to repeat all of the blo-compatibility tests. It may turn out that the delay is not as long as you think.

-Shimon
 

rwend07

Involved In Discussions
#4
The purpose of the RTA is to ensure that all information required for the reviewers to begin the substantive review is present. Back in the day, FDA would accept incomplete submissions and then start and stop as results were made available. The resulted in long review times and in some cases wasted effort when the submission was never completed.

Taken to the extreme, if "placeholders" were allowed, it would be possible to submit a 510(k) with no results, only the promise to have them ready at some later date. There would be nothing for FDA to review.

I would ask the question as to whether the consensus standard to which the testing was done was recognized by FDA at the time of submission (or shortly before). If it was not, you can submit either an audit showing the differences between the old and new standard OR a justification for why the older standard was used. That might be enough to get the submission back on track. You might try that tactic while getting the test results ready.

Another option open to you is the Q-sub, if you want to get a feel for what information the reviewers think they need to give you a positive decision.

It can be frustrating, that is for sure. I wish you luck!
Thanks Jean. It is a bit of an interesting situation. The recognized standard that was used is a device specific guidance (for airway accessories) and specifically defined the biocompatibility testing required (skin contact - permanant duration) for our type of device. Unfortunately, it also had a line in the section that said "the gas pathways should be evaluated to ISO 18562-1:--, upon its publication". With our luck, after we had solidified our regulatory strategy and begun our testing, the new standard 18562 published superseding the original biocompatibility guidance without us noticing (oversight on my part) so we submitted the 510(k) assuming skin contact was sufficient and got ourselves into this predicament. This new 18562 is not a recognized consensus standard currently, however I'm assuming it still counts as one because it is referenced in the other standard that is recognized and it appears the testing the FDA is requesting aligns with the standard.

I definitely understand why they require final test reports for the most part, but for something like this it seems like it should be addressed during a substantive review and then placed on hold until test reports are available. If we clearly define the testing that is being done and when it will come through, I don't see the issue from a review time perspective. They can always place it right back on hold in substantive pausing the clock, but at least we would be able to address other deficiencies in parallel instead of having everything linear (if that makes sense).

Thank you both for your perspective on the matter.
 

JeantheBigone

Quite Involved in Discussions
#5
Well as tough as it is to have to respond to the RTA, FDA may be doing you a favor by addressing this in the RTA rather than the substantive review. One difference between the RTA and the AI (additional information) request is that you can have multiple rounds in RTA, but for the AI, you get one shot which has to be done within 180 days. I know, it sounds like FDA can keep asking for more during the RTA. But the possible advantage is that if something is "off" in a report and FDA catches it in RTA, you have more opportunities to correct it than if you are past the RTA stage.

At any rate, good luck!
 

Edward Reesor

Trusted Information Resource
#6
Question for the group in relation to this issue:

If you applied for a 510(k) using a predicate device which was manufactured at the same facility using the same materials, does and entirely new series of 18652 testing have to be completed?
 

JeantheBigone

Quite Involved in Discussions
#7
Several different factors come into play here.

The first is if the testing standard is one recognized by FDA and if the predicate device was tested to a previous version of the standard no longer recognized by FDA. That does not appear to be the case here.

The second is that FDA generally wants to see testing on final finished devices. If anything has changed, and that includes the equipment used to manufacture, process, finish, clean etc the device, the more than likely FDA will expect testing on the current device.

Hope that helps.
 
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