Hi,
I need some direction regarding labeling requirements for Private Brand OTC Class II medical device.
We are the legal manufacturer - own the 510(k) and label the product with the private brand name.
My understanding is that we(legal manufacturer) need only state on the labeling
Manufactured for XXXXXXXX or Distributed by XXXXXXXX and there is no requirement for us (legal manufacturer) to put our name on the product.
There has been discussion that some feel the manufacturer, according to IEC 60601 must have their name on the label.
I have not found anything which states that the manufacturer must have their name on the label so long as we are clear by stating "Manufacturer for" or "Distributed by".
Your help/input would be greatly appreciated.
I need some direction regarding labeling requirements for Private Brand OTC Class II medical device.
We are the legal manufacturer - own the 510(k) and label the product with the private brand name.
My understanding is that we(legal manufacturer) need only state on the labeling
Manufactured for XXXXXXXX or Distributed by XXXXXXXX and there is no requirement for us (legal manufacturer) to put our name on the product.
There has been discussion that some feel the manufacturer, according to IEC 60601 must have their name on the label.
I have not found anything which states that the manufacturer must have their name on the label so long as we are clear by stating "Manufacturer for" or "Distributed by".
Your help/input would be greatly appreciated.
