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?

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