invitro_spain
Involved In Discussions
Hello,
We are In vitro medical devices foreign manufacturers. When I registered the company and the products list as ASR on the FDA Website I have selected the following options: Manufacturer and complaint file establishment.
I have a doubt with this option, I guess that this option is according to the 21 CFR 820.198 but maybe I missunderstood the concept. I saw that the others appear as Manufaturer only.
Can anybody help me?
Thank you
We are In vitro medical devices foreign manufacturers. When I registered the company and the products list as ASR on the FDA Website I have selected the following options: Manufacturer and complaint file establishment.
I have a doubt with this option, I guess that this option is according to the 21 CFR 820.198 but maybe I missunderstood the concept. I saw that the others appear as Manufaturer only.
Can anybody help me?
Thank you