Regulatory Open Forum

Hello,

I am curious if anyone has experience with or heard of a catch up 510(k) being rejected?  Is anyone aware of this happening?  If so, what were the ramifications for currently marketed product?

Thank you all!

I have had clients approach me during and after an existing 510(k) notification was in jeopardy.  Sometimes the issue can be salvaged in that 510(k), sometimes not, and sometimes never.  To give definitive advice, we would need to know more details about the subject device indications and technological characteristics and the specific facts surrounding the 510(k) "being rejected" [that's not an actual status given to 510(k)s by FDA] and about the full context/purpose/scope of the 510(k) with respect to currently marketed product.  In the meantime, here are a few thoughts.

If the "catch-up" 510(k) was unsuccessful, the particular details of the case need to be known in order to understand the specific ramifications.  But ultimately, if the marketed product in its current embodiment is not the subject a valid corresponding 510(k) clearance (or other legally marketed status/route), then that product is considered to be "misbranded" (a statutory type of illegality).  FDA might give some grace for that situation depending on the scenario.  Yet, if your catch-up 510(k) effort failed and if FDA knows you have marketed, or are currently marketing, the misbranded device version, then such grace will likely run out soon.  FDA's reaction to continued marketing could easily be an escalated compliance gesture like requiring a recall or issuing a Warning Letter, or both, or more.  You need to be leaning on a solid and proper risk analysis and expert assistance (if not already deployed) to properly understand and manage the potential ramifications.

Hello Anon,

There would need to be further information provided why the 510(k) submitted is in 'jeopardy' to understand the situation better in order to comment.  There can be ramifications on the current product in the market, but really depends what type of product, the situation of the submission, what the "catch-up" was being done, and impact on safety or efficacy (performance) of the devices still on the market.