Medical Device Research Use Only (RUO) label

SANE

Starting to get Involved
#1
Dear all,

I am a rather beginner in the regulatory affairs for IVD diagnostics and some questions which will come from my side may sound quite naive.
We want to offer our products now also as RUO products. We have adapted the technical file, the SDS and now I want to adapt the labels. Having checked the ISO 152233 and the ISO 7000, I do not find the RUO symbol.
Can somebody tell me where I can find it? My search was without success.
Thanks for your support.
 
Elsmar Forum Sponsor
#4
Dear all,

I am a rather beginner in the regulatory affairs for IVD diagnostics and some questions which will come from my side may sound quite naive.
We want to offer our products now also as RUO products. We have adapted the technical file, the SDS and now I want to adapt the labels. Having checked the ISO 152233 and the ISO 7000, I do not find the RUO symbol.
Can somebody tell me where I can find it? My search was without success.
Thanks for your support.
Hello,

I am interested in this topic, since we have to sell our IVD reagent kits and instruments as RUO (Europe and US). Which are the laws that we need to respect? expecially for US... thank you!
Maria Elena
 

indubioush

Quite Involved in Discussions
#5
Hello,

I am interested in this topic, since we have to sell our IVD reagent kits and instruments as RUO (Europe and US). Which are the laws that we need to respect? expecially for US... thank you!
Maria Elena
21CFR809 for US: CFR - Code of Federal Regulations Title 21

(i) For a product in the laboratory research phase of development, and not represented as an effective in vitro diagnostic product, all labeling bears the statement, prominently placed: "For Research Use Only. Not for use in diagnostic procedures."

By the way, I find it a bit scary that you say you are selling your RUO kits and instruments, but I don't know all the details of course.
 
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