FDA product code and regulation number

Harini17

Involved In Discussions
#1
Dear Experts,

We have a question w.r.t accessory device in the hemodialyzer machine i.e, it's a hollow
fiber filter used during therapeutic plasma filtration in the dialyzer.
According to Our understanding, the FDA regulation is 21 CFR 876.5820 and
the product code would be KOC. Others argue that no it's 876.5860 and the
product code is KDI. Kindly clarify on this which regulations and product
code does this belong to most appropriately.

Looking forward to hear from you soon.

Thanks
 
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QAengineer13

Quite Involved in Discussions
#2
Dear Experts,

We have a question w.r.t accessory device in the hemodialyzer machine i.e, it's a hollow
fiber filter used during therapeutic plasma filtration in the dialyzer.
According to Our understanding, the FDA regulation is 21 CFR 876.5820 and
the product code would be KOC. Others argue that no it's 876.5860 and the
product code is KDI. Kindly clarify on this which regulations and product
code does this belong to most appropriately.

Looking forward to hear from you soon.

Thanks
Hi Harini,

You can definitely get an opinion from fellow cove members if they are familiar or worked in the same field as yours but another option would be to contact:

Information-Medical Devices / Radiation Products
Division of Industry and Consumer Education
CDRH-Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
 

Harini17

Involved In Discussions
#3
Hi,

Thanks for your suggestion. I already contacted CDRH, but you know FDA will always ask us to submit 513(g). The product code and regulation number confirmation is needed just to quote in the doc that it belongs to this code in US.

In 2015, it was considered as class 3 with 876.5860 regulation. But now there is a change, it's now considered as class 2 with 876.5820 or 876.5860. Acc to me it's 876.5820, since it's a accessory. But I need confirmation from Experts.

Thank you.
 

QAengineer13

Quite Involved in Discussions
#4
Hi,

Thanks for your suggestion. I already contacted CDRH, but you know FDA will always ask us to submit 513(g). The product code and regulation number confirmation is needed just to quote in the doc that it belongs to this code in US.

In 2015, it was considered as class 3 with 876.5860 regulation. But now there is a change, it's now considered as class 2 with 876.5820 or 876.5860. Acc to me it's 876.5820, since it's a accessory. But I need confirmation from Experts.

Thank you.
I get what you mean,Harini. But at the end of the day its the FDA's blessing is what you are after. Good Luck!
 
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