April 5, 2023

FDA 510(k) Aggregate Change Analysis for Special 510(k)-Cleared Devices

A Special 510(k) is intrinsically by definition a 510(k) intended to detail only a 510(k)-cleared device modification(s) rather than to detail the 510(k)-cleared aspects that haven’t been modified.  This means that the subject device described in the Special 510(k) cannot be fully characterized and understood simply by what is stated directly in the Special 510(k) document submission.  Indeed, FDA itself says that [see the Special 510(k) guidance], in order to have a complete understanding of the device under review, the Special 510(k) is to a) detail the change(s) made that triggered the Special 510(k), and then also b) regarding the aspects that weren’t changed, “…state that no changes were made“.

So a properly written Special 510(k) will simply make such a generic statement for whatever 510(k)-cleared aspects haven’t been changed.  In other words, those unchanged aspects are “incorporated by reference”, and thus aren’t actually described directly in the Special 510(k) submission.  But this certainly does not mean that those unchanged 510(k)-cleared aspects are no longer part of the device’s current 510(k) clearance.  They are definitely there, specifically by way of their incorporation by reference into the Special 510(k).  Therefore, to fully understand those 510(k)-cleared attributes, one is forced to go to the 510(k) submission document where they were detailed.

Ultimately, it is in contravention of U.S. medical device law to assert that those unchanged 510(k)-cleared aspects are somehow nullified by their generic incorporation by reference into the Special 510(k).  Again, a Special 510(k) is intrinsically for detailing modifications that are to be paired with the various unchanged 510(k)-cleared aspects so as to represent the full 510(k)-cleared version.