You cannot get your product cleared through FDA via the 510(k) process unless FDA determines it is substantially equivalent to a predicate. It must have the same intended use
AND1. technological characteristics that are
the same as those of the predicate device.
OR
2. technological characteristics that are different from those of the predicate devices, AND
the device is as safe and effective as the predicate device AND
the technological differences do not "raise new questions of safety and effectiveness."
If by "we want," you are saying that your company management is stubbornly insisting on a 510(k) even though it is clear that the above criteria are not going to be met, I recommend you tell consultants that you are looking for someone who will assist you with the content of the submission, but will not be responsible for advising you on whether or not the data are adequate to support substantial equivalence. That's a happy situation for most consultants, since it is usually the latter responsibility that is the regulatory PITA, not the submission itself.
On the other hand, if you really want to know, clarify that you are looking for someone who can also help you assess the likelihood that FDA will accept the data as supporting SE.
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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: 19-Apr-2018 03:12
From: Sayaka Takami
Subject: 510k availability for advanced wound care product
Hi, all.
We are Japanese chemical company and looking for a good FDA consultant for our advanced wound care product.
We are going to launch it first in US and then expand to other regions. The product is made of unique genetically-recombined protein, but we want 510k application.
As we have no experience in US, it would be appreciated if some of you might help us.
Sayaka
Sanyo chemical, Japan