Hello, everyone - long time lurker, first time poster!
I am a development engineer at one of the "Big Five" orthopaedic companies. I am currently finishing a Master's degree in Regulatory and Clinical Affairs (Amazing how much better I am at my job now that I know a lot more about RA/CA), and right now I am working on a project to develop regulatory and clinical strategies to support a feasibility proposal recommending my company to pursue a new market sector (Spine).
Anyway, I've come across a tiny sticking point that I cannot seem to find an answer for - I've tried searching through these forums, FDA's website, FDAnews.com, and taken a shotgun-approach to Google...But I cannot find any definitive evidence either way. So my question to all of you out there is:
If I develop an instrument that is specifically designed to be used only during the implantation of a unique medical device, does that instrument's US classification default to the same class as said implant device? When I am at work doing real-world medical device engineering projects, I have always just included instrumentation in with the 510(k) and whatnot... So I am not real sure if this is just something I misinterpreted along the way, or if unique instrumentation used for the implantation of a specific device really are upclassified.
I've asked a regulatory specialist at work also, and she said they do default to the implant's classification - but she couldn't find any objective evidence to show the FDA's stance actually is that.... I can't post links yet, but the only thing I could find even mentioning it was a linkedin discussion that did not really get anywhere or cite sources.
Thanks for any guidance you can provide