March 3, 2023

FDA 510(k) Modifications – Inclusion of Non-Triggering Change Details

If multiple changes have been made to the subject device since the prior 510(k), but where only one/some of those changes trigger(s) the need for a new 510(k), and if the aggregate of changes isn’t what’s triggering the need for the new 510(k), then you “should” (meaning this isn’t a requirement) in the 510(k) simply identify and describe the nature of the changes that don’t require submission of the new 510(k).   Indeed, the actual mandate regarding the non-triggering changes is for you to detail those aspects internally in accordance with the QS regulations.  In other words, the developmental documentation and data (e.g., test results/reports, etc.) associated with the non-triggering aspects should definitely NOT be included in the 510(k).  Instead, keep the substance of the 510(k) focused on those aspects that triggered the 510(k) for the changed device; specifically, those changes that can “significantly affect safety and effectiveness”.  I explain further below.

A 510(k) is a statutory creature that has a very specific purpose; namely, to demonstrate the statutory substantial equivalence of the subject device in comparison to a predicate device.  Accordingly, I generally advise and practice that the substance of the 510(k) needs to be strictly and succinctly focused on that statutory substantial equivalence assertion.  My clients will tell you my mantra that every word, sentence, and component of the 510(k) needs to be strategically written so as to specifically address the substantial equivalence statute and regulations.  Any information and data that doesn’t directly relate to this substantial equivalence exercise only convolutes the aim of the 510(k), and can easily confuse and frustrate the FDA reviewer.  This is because the inclusion of data not related to the substantial equivalence assertion signals to the FDA that the sponsor believes that those aspects are in fact germane to the substantial equivalence effort. In other words, that those attributes could significantly affect safety and effectiveness. Don’t lead FDA down that path unless it is truly necessary from the standpoint of the statutory intent of a section 510(k) notification.

If disclosing a non-triggering change(s) at all, then I prefer to put each change’s explanation in the subsection of the 510(k) corresponding to the nature of the particular non-triggering change.  For example, if a non-triggering change has been made in the labeling, then I disclose that in the labeling subsection.  If a non-triggering change was made regarding form/fit/function, then I disclose that in the device description (among other corresponding subsections as appropriate), and so on.