Can YOU help? --> Unanswered questions <-- (Other than Marcelo's Informational posts)

#1
My company is repackaging and distributing RUO products. A customer intends to use an RUO product in the IVD kit they are developing. Our facility handling this product is non-compliant to any quality standard. Although sold as an RUO, this customer wants us to acknowledge and agree that they will use the product as a component of IVD products that will be distributed worldwide. Would that arrangement subject my company to FDA scrutiny?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#3
"FDA scrutiny" is a very broad term. Technically speaking, yes your company will be within FDA jurisdiction, but as what / to what extent?... The answer is "As a component supplier to a medical device (IVD) manufacturer." As such, I don't think that the direct implications will be too onerous. Other than that the customer might require all sorts of things under their supplier qualification process, but I wouldn't relate to that as "FDA scrutiny". It also matters how critical this component is within the context of the customer's device.
 

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