FDA wants your comments!! Your chance to be heard – Unique Device Identification Convenience Kits
FDA announced an opportunity for public comment on the guidance document for Unique Device Identification Convenience Kits. Prior to the UDI rule, as per 21CFR 801.30 there was a general thinking that Medical procedure kits including orthopedic procedure kits are convenient kits. But the passage of UDI rule let to the interpretation that Implantable device,