An IVD and RUO have different regulatory status, so a product cannot be both.
Potentially, a product could be an RUO for a new use or indication, but this seldom happens. It also complicates inventory management.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 23-Aug-2022 09:59
From: Anonymous Member
Subject: IVD and RUO
This message was posted by a user wishing to remain anonymous
Hi,
I wanted to get an insight whether can we as a manufacturer sell an identical product labelled as IVD (upon clearance) and also as a Research Use Only (RUO). In other words, can you sell the same product labelled either as IVD or as RUO?
Thank you