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User manual / instructions for use for class II device always required?

#1
Our company plans to include a sterile saline flush syringe from an external company in the package for our class II device, just for the convenience of the user. The saline syringe is a 510(k) cleared class II device, and the whole device will also be a class II device. My question is: Will the FDA require us to include the instructions for use / user manual (from the other company) for the syringe in our package?
 
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Ronen E

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#2
First you need to clarify whether "your package" is a convenience kit (specific FDA expectations apply) or just 2 devices - yours, and the syringe in its original package - packaged together for shipping / wholesale purposes.
A third scenario is that "your device" is the syringe + other objects that you make (or source), packaged together is a primary/retail packaging. In this case the syringe is a component and its 510(k) is less relevant. If that's the case you'll need to look at all that as one device, and provide appropriate labelling.
 
#3
Thanks for your reply, Ronen E. I think we have the third scenario. In EU there is a rule saying that you don't necessarily need to provide IFUs for device classes IIa and under, but there is no similar rule in the US, am I right?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
In EU there is a rule saying that you don't necessarily need to provide IFUs for device classes IIa and under
This is an inaccurate statement (as phrased).

You can find all the applicable labeling rules (USA), including any exemptions, in 21 CFR 801 and here.
 
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