J
We recently had a new product accepted by the FDA and they had us remove the words specificity and sensitivity from the direction insert. We had labeled the results of testing as both Sensitivity/Copositivity and Specificity/Conegativity. For EU, Sensitivity and Specificity are required---but FDA won't even allow those words in the insert. But, of course, the EU requirements do not explain the "but if's".
I understand their reasoning.....our diagnostic kits are not linked with a specific diagnosis. They are kits used to aid in determining diagnosis but without a direct analytical correlation.
Are there any guidance documents anyone knows of that might help me sort this out? Or, any other information that might help?
I understand their reasoning.....our diagnostic kits are not linked with a specific diagnosis. They are kits used to aid in determining diagnosis but without a direct analytical correlation.
Are there any guidance documents anyone knows of that might help me sort this out? Or, any other information that might help?
