I haven't done one, but yes, I've heard of them. I can think of two reasons to do a catch-up 510(k):
1) It will facilitate future product development by giving you a "clean" 510(k) to serve as a basis for future modifications or future devices for which you might use the "caught up" device as a predicate.
2) "Pay me now or pay me later." By this I mean you are starting to get the uncomfortable feeling that your device has morphed bit by bit by bit over time to the point that maybe it might not bear close regulatory scrutiny today. So, better to subject it to scrutiny now, and deal with the results of that scrutiny now, than keep putting it off until one day scrutiny happens, and by then it's gotten even more out of hand and you have a major regulatory headache to deal with. Also, the general wisdom is that such things will always go better with FDA if you bring it to their attention on your own initiative, rather than waiting for FDA to bring it to yours.
Of course, whenever you ask FDA to look at something, you can't know what its response might be, so you would want to think about worst case scenarios and be prepared to deal with them if need be. From the perspective of the regulatory professional, you want to make sure your management fully understands the pros and cons and is fully on board (in writing, so it really happened) with the idea.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 12-Jan-2017 14:47
From: Aliva Das
Subject: Hello everyone,
Is anyone aware of a Catch up 510(k) for Medical Devices. Has anyone done or thought of similar kind of submission?
Please advise and provide inputs if any.
Thanks,
Aliva Das
Regulatory Associate
Glidewell Dental Labs