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FDA has an agreement with EPA where low-level disinfectants used in areas like hospital rooms are regulated by EPA. A client has a low-level EPA-approved disinfectant cleared to inhibit microbial growth on the surface to which it is applied.
But recent lab tests show that items that contact the activated surface also have decreased bio-burden even though there is no application of the disinfectant to the object.
In order to claim this as an intended use, would this now be classified as a medical device, akin to a UV sanitizing unit?
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