J
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
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