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FDA Supplier Labeling Requirements

E

ElizaB

#1
#1
Hi all,

I work for a component supplier (not a "component" as the FDA defines it) for several medical device manufacturers. We do not manufacture a finished device but we are ISO 13485 certified.

The only labeling requirements I can think of are that we have a process specified (product and service provision). We review and control the label templates, and we keep records of the labels. Outside of this, any additional labeling requirements would be those imposed by a given customer, right?

Thanks for your time :)
 
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