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Biocompatibility for Class I Non-Sterile Medical Device

J

jennaleeb

#1
Hello and thanks again to everyone that posts on this forum!

We are manufacturing a Class I nonsterile device which is intended to be used to collect a vaginal specimen. We have performed cytotoxicity testing on the final product (results grade 0, no cell lysis) and our subcontracted manufacturers have used the same raw materials in another vaginal specimen collection device and performed cytotox, irritation and sensitivity testing with no findings.

Is the needless slaughtering of more animals called for?! It would seem we could analyse the available evidence as well as the results from cytotoxicity.

Any advice on the matter is appreciated!

Jenna
 
Elsmar Forum Sponsor
M

MIREGMGR

#3
We are manufacturing a Class I nonsterile device which is intended to be used to collect a vaginal specimen. We have performed cytotoxicity testing on the final product (results grade 0, no cell lysis) and our subcontracted manufacturers have used the same raw materials in another vaginal specimen collection device and performed cytotox, irritation and sensitivity testing with no findings.
Will they provide you with copies of their irritation and sensitization reports? Can you rigorously show that there are no differences in processing from raw materials to finished product that could affect biocompatibility?

If so, and given that this is Class I, I think you could refer to the other-product testing and not do your own testing.

Is the needless slaughtering of more animals called for?!
This of course is irrelevent to the regulatory compliance question, however important it might be to you and me ethically.
 
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