M
Hi all,
Our customer (U.S. company) requires us (E.U. company) to register, list and pay the Device Facility User Fee with FDA.
This is a surprise for us, as since 2004 we have been working with this company and there is no changes on products or specs.
We are approved supplier of the U.S. company. We supply them and manufacture under their specifications medical instruments packaged and labeled under class I (exempted), and the U.S. company is who puts on the U.S. market and distributes under it's name and trademark the medical instruments.
There is no information about our compnay on labels or product sheet as manufacturer..
My question is: Should our company register, list and pay the Device Facility User Fee with FDA?
Thanks!
Our customer (U.S. company) requires us (E.U. company) to register, list and pay the Device Facility User Fee with FDA.
This is a surprise for us, as since 2004 we have been working with this company and there is no changes on products or specs.
We are approved supplier of the U.S. company. We supply them and manufacture under their specifications medical instruments packaged and labeled under class I (exempted), and the U.S. company is who puts on the U.S. market and distributes under it's name and trademark the medical instruments.
There is no information about our compnay on labels or product sheet as manufacturer..

My question is: Should our company register, list and pay the Device Facility User Fee with FDA?
Thanks!