Regulatory Open Forum

Good day Thom,

You will not find that stated anywhere in a regulation which prohibits this being done, but also does not necessarily allow.  What it comes down to is why two 510(k) premarket notifications to the US FDA are being made at the same time with the same device.  In some circumstances, this might be feasible.  From previous discussions and "non-public" information sharing the FDA makes comments about the 510(k) process being "serial" for the same device.  It also depends directly on the predicate device which is being used.  As an example, I worked at a company years ago where we had Product X and Predicate Z.  They wanted to submit Product X for an indication under one submission using Predicate Z.  Then they wanted to submit Product X for an expanded indication under another submission using Predicate Z, but also our own device as a predicate.  It can be understood you can only use a predicate once cleared, though the rationale company was using, "Well, they can just look at the submission already made."

Not really how the 510(k) submission process works because the different submissions can muddle each other.  There can also be many other considerations made such as type of clinical data, testing involved, labelling, and the indications for use being sought.  So the key is in what you wrote: 'then a second 510(k) should not be submitted until ...' because it depends on the reasons why these two topics can not be submitted under one submission.  Definitely I can comment, the more complicated the submission is to understand the more challenges will be encountered; thus organisations make submissions one after the other to complete one and then move onto the next.  In fact, I have worked on submissions where once we got the 510(k) clearance, literally the next day we submitted the next submission.

I've seen two 510(k)s at the same time quite frequently for diabetes devices. For example, an insulin pump might have a 510(k) for the new pump and its software at the same time as a 510(k) for the bolus calculator. FDA clears both at the same time. Similarly, iCGM devices might split to have one 510(k) for physical design changes and another for software. Whether this is acceptable may depend on the OHT and how the different changes interact or if they are sufficiently separate.