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Active Surface Disinfectant Claims - FDA vs EPA and Hands vs Objects

markl368

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#1
I have a client who has developed a novel low-level active disinfectant for non-terminal applications. As such they fall under EPA rather than FDA regulation. Recent lab studies have found that placing objects on the active surface reduces the microbial bioburden on the objects, whether it be hands or things like cell phones. This is not the intended or cleared use...the cleared use is as a disinfectant for the surface to which is applied.

I've cautioned my client that if they want to pursue antimicrobial effect on hands, this would fall under FDA regulation as an antiseptic, and until it is approved as such, they cannot claim anything that supports this use. I'm clear on that.

My question though is whether publishing claims of disinfection of objects placed on the active surface would fall under FDA medical device regulation. This is certainly beyond the EPA cleared statements, but I'm thinking this might be something that would be akin to a "system" such as a low-level UV decontamination system.

Interested in hearing your thoughts.
 
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