Biocompatbility testing on Class 1 device requirements

[planB]

I'm not sure even FDA knows what it thinks about all of this. I don't know that it's had enough exposure to devices claiming to be 510(k) exempt to have even developed an opinion. Especially an informed opinion.

Everything agreed except: Being the regulatory authority in the largest market for medical devices with oversight over more devices than anybody else worldwide, I would personally be cautious to assume FDA has not an informed opinion. Just my 2 cents.

 

[Watchcat]

Everything agreed except....I would personally be cautious to assume FDA has not an informed opinion. Just my 2 cents.

Ah, but you can't disagree with me about assuming, because I haven't. You can disagree with me that I don't know or that I'm not sure, but not about assuming. The Regulatory Watchcat is dedicated to finding out. When and if I do, everyone in this forum will be among the first to know.

 

[monoj mon]

Yes, but in the Introduction to that document, it states that the guidance is to assist in preparing premarket applicatons HDEs, IDEs, 510ks, and De Novo request. The trach tube holder is exempt.

I once submitted a premarket notification for a whole set of devices which included two 510(k) exempted devices. One of them stays inside the sterile field and comes in contact with intact skin occasionally while the other one stays outside the sterile field. I conducted biocompatibility testing for the former one while I didn't conduct it for the one which stays outside the sterile field although both are connected to each other. This strategy was acceptable for the reviewer. I hope this will give you more confidence while making the decision.