This message was posted by a user wishing to remain anonymous
Former FDA here and converter of many a Special 510(k). As everyone else said, in principle you can put in a Q-sub. But in practice it will take forever and be fairly pointless. You can answer the questions on your own: Are you modifying your own device, are there well established methods of testing its performance, and is a summary of the test data (instead of all the test data itself) enough to evaluate the device? The answers might be subjective, but you can come up with SOME answer and justify it, which is the best anyone can do. Also, you can research whether predicate devices have been submitted as Specials.
The question of "are summary data enough?" often does not have a good answer. I mean, let's say your output is data on noise. What is the "summary" really? Is it a plot of the data? FDA basically tries to be consistent with its own previous decisions, so it's important to research those if possible.
I'd just submit as a Special and be prepared in case FDA converts it to Traditional, in which case you might have to submit your test reports and software documentation in more detail. Frankly although it shouldn't be, in practice the conversion process at FDA can be somewhat subjective and can also depend on the reviewer's workload at the time. Conversion requires effort on the reviewer's part; it must be justified to management as well as a special department that handles conversions. It also requires that the reviewer know how previous similar 510k's were handled.
To be honest, with all due respect to Lee, I would leave out the paragraph in the cover letter that you mentioned. FDA reviews every single Special to see whether it should really be a Special, they decide the date that the clock starts, and they do notify sponsors of conversion. The process is the same for every submission, much of it is automated by their IT tracking system, and it is very, very well defined, so there is no need to make special requests. As a reviewer I had a load of up to 14 submissions at a time--I wouldn't necessarily have paid attention to (or appreciated) advice from industry on how to run my review or what communications to make.
Original Message:
Sent: 20-Jan-2021 12:28
From: Anonymous Member
Subject: FDA Pre-sub for special v. traditional 510 (k) submission opinion
This message was posted by a user wishing to remain anonymous
Hello! Has anyone ever use the FDA's pre-submission program to gain an opinion on whether a special or traditional 510(k) is the correct submission pathway? If so, can you share your experience? Thank you.