Hello!
I have a differing opinion from my colleagues, so I would like to get other's opinions on the scenario below.
I received a change notice that is adding equipment at a sub-supplier to expand manufacturing capacity. The new equipment will change a part of the process from manual to automated.
We do not hold the relationship with this component supplier. Rather, our contract manufacturer maintains this relationship (it's the supplier of the contract manufacturer).
My question is do we need to report this change to FDA? The component specifications remain the same. Nothing is changing from how our device is manufactured at the contract manufacturer.
Thoughts?
I have a differing opinion from my colleagues, so I would like to get other's opinions on the scenario below.
I received a change notice that is adding equipment at a sub-supplier to expand manufacturing capacity. The new equipment will change a part of the process from manual to automated.
We do not hold the relationship with this component supplier. Rather, our contract manufacturer maintains this relationship (it's the supplier of the contract manufacturer).
My question is do we need to report this change to FDA? The component specifications remain the same. Nothing is changing from how our device is manufactured at the contract manufacturer.
Thoughts?