Two separate 510k submissions for one device from the same company

JeantheBigone

Quite Involved in Discussions
#11
You can have as many 510(k)s in review concurrently as you want. :) Usually you don't want TOO many, in case you get an AI letter and are in a time crunch to reply......

FDA won't "send back" a 510(k) submission currently in the review process. They have no basis for doing so. The submitter can withdraw it, or the submission can end because either a NSE decision was reached OR the submitter failed to respond to an AI request. But that's it. Submitting an additional 510(k) for a similar device won't affect a submission currently in review.

And it's not uncommon for a submitter to decide in the middle of a review that they'd like to make a change. Can't be done however. So.....you need a new 510(k). They know that at FDA.

The question is...are the new Indications for Use sufficiently different that if the current device can't be used as a predicate if it gets cleared? Or the device(s) serving as a predicate for the existing submission? If so then I tend to agree with management - submit an additional 510(k) now so you can start marketing it sooner rather than later. If not, wait for clearance for the existing submission, then use THAT as your predicate to make the technical part of the submission easier (assuming the technological characteristics are really and truly identical).

@ QAEngineer13: The RTA hurdle is cleared at the beginning of the review and simply serves to ensure that the submission is administratively complete. If the first submission has already cleared the RTA hurdle and is on its way to the substantive review, FDA has no basis to backtrack and say that the submission was not administratively complete. The RTA checklist doesn't have anything that checks for contingencies on related submissions from the same submitter.
 
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