Call it refurbish or not? Medical Devices

#1
Hi !
Our company is discussing the possibility to start a refurbish line. These are my questions;
1. Is calling it "refurbish" a correct name/ process?
2. What are the impacts for CE & FDA submissions, we already have?

Thanks
Simona F Krant
 
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yodon

Staff member
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#2
If you go to the FDA Guidance Search page and enter 'reprocess' in the search box, there are 10 guidance docs (not all will be applicable). That's probably a good start if that's indeed, what you're doing. If you're just doing service, it just falls under standard controls.
 
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