I'm currently struggling with the following situation:
We've identified a great predicate that has the same technology and indications for use.
But, when I look up their 510(k), I notice that the listed product-code is inaccurate (there is a much more concise code to describe), and the listed review panel is obviously wrong (has nothing to do with the device).
So I'm struggling with the following decision: In our 510(k) should we:
a) Just list the same pro-code & panel, despite them being inaccurate/incorrect, or
b) Correct the error and use a more accurate pro-code, and the correct panel?
(b) is obviously preferable (as the resulting listing would more correctly describe the product), but I'm afraid that it would stall the approval process...
Any advice/input much appreciated...
We've identified a great predicate that has the same technology and indications for use.
But, when I look up their 510(k), I notice that the listed product-code is inaccurate (there is a much more concise code to describe), and the listed review panel is obviously wrong (has nothing to do with the device).
So I'm struggling with the following decision: In our 510(k) should we:
a) Just list the same pro-code & panel, despite them being inaccurate/incorrect, or
b) Correct the error and use a more accurate pro-code, and the correct panel?
(b) is obviously preferable (as the resulting listing would more correctly describe the product), but I'm afraid that it would stall the approval process...
Any advice/input much appreciated...