510K Interactive Review

[katiesam]

We have had notification that our submission has passed through substantive review and that any discrepancies will be brought up during the interactive review process.
AS far as I can see the deadline for interactive review is in two weeks time and we have yet to hear anything. Does anyone know if discrepancies are usually brought up at the time the submission passes to interactive review?

I am hopeful that we would be given time to answer any questions before the deadline.

Any advice from people who have gone through this before would be much appreciated.

 

[mihzago]

What I think is that your lead reviewer completed the substantive review process without identifying any significant issues that would require an RAI letter.

I assume that when you say that you are nearing the deadline for interactive review is that you're getting close to the 90-day review goal for the submission.

So what this all means, it appears, is that your submission is being reviewed by the management, and is very close to getting clearance, but sometimes during the management review minor issues come up that you may have to address interactively. For example, your lead reviewer may ask you to tweak language in your indications for use or in your labeling and requests that you do it in 2-3 days.

I think you're almost there. Congratulations!

 

[katiesam]

Thank you for providing a really helpful insight into the 510k process. The 90 days review goal is in two weeks time, so we are now feeling much more hopeful, fingers crossed for celebrations towards the end of the month!

Thanks again.