Solidifier and Spill Kits in US - Why is it registered in EPA not FDA?

#1
Hey guys

Can any one please explain to me what is the regulation for Solidifier and Spill Kits in US and why its registered in EPA not FDA but i found in the FDA website body fluid disposal kit with product code OKF and under regulation number 878.4040.

I also posted a topic in EU medical Device if any one can help me with this Solidifiers.:cool:

thanks all
 
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Steve Prevette

Deming Disciple
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Super Moderator
#2
My assumption would be is once something is "spilled" it is now "waste" which is regulated by the EPA. When it was "in process" materials it would have been regulated by FDA.
 
#4
Thank you every body.

But I want to know what is the regulation of the product it self not the waste after the procedure.

why some products registered in FDA and why others registered in EPA?!!

Thanks every one :)
 

harry

Super Moderator
#5
........................ why some products registered in FDA and why others registered in EPA?!! .........................
If your interest is in products like spill kits, those meant to be used in the FDA regulated environment such as blood spill kits would naturally be regulated by FDA. General use chemical spill kits would naturally come under the purview of EPA.
 
M

MIREGMGR

#6
EPA and FDA do not coordinate with each other.

EPA has a defined scope. So does FDA. The boundaries are sometimes fuzzy because the real world involves hard judgment calls. It's common for two seemingly equivalent products near a scope-boundary to be regulated differently. Gellants ("liquid waste solidifiers") might be handled like that.
 
#7
If your interest is in products like spill kits, those meant to be used in the FDA regulated environment such as blood spill kits would naturally be regulated by FDA. General use chemical spill kits would naturally come under the purview of EPA.

EPA and FDA do not coordinate with each other.

EPA has a defined scope. So does FDA. The boundaries are sometimes fuzzy because the real world involves hard judgment calls. It's common for two seemingly equivalent products near a scope-boundary to be regulated differently. Gellants ("liquid waste solidifiers") might be handled like that.





Thank you very much guys :agree1:
 
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