Sensitivity vs. Specificity - FDA won't even allow those words

J

jewels

#1
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".:confused:

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? :thanks:
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
I've never come up against anything like this not being FDA.

Does this ring a bell with anyone?
 

Al Rosen

Staff member
Super Moderator
#3
jewels said:
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".:confused:

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? :thanks:
I'm not familiar with IVD's but is this link to the FDA guidance on Lab Test Labeling what you are looking for?

http://www.fda.gov/cdrh/ode/1352.html

I think the following paragraph, I found in the guidance document, explains it.
FDA Guidance said:
A test that has been characterized to a predicate but has not been compared to "true" diagnostic states should be labeled WITHOUT sensitivity or specificity claims. Relative performance may be described in terms of agreement, co-positivity and co-negativity, or using other similar terms.
 
J

jewels

#4
Thank you for your input

We did have the FDA guidance on co-positivity and co-negativity and hit that nail on the head. We linked these terms with sensitivity and specificity and the FDA didn't like that. So, we need to revamp our Performance Characteristics so they are acceptable to both FDA and the MDD.

Thanks for your help....
 
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