UDI Rule a Challenge for Ortho Company (MDDI)
Orthopedics company Globus Medical asks FDA to exempt already-distributed implant inventory from the Unique Device Identifier (UDI) labeling rule.
The long shelf life and uncommon business model of orthopedic implants is presenting a hitch in implementing FDA's Unique Device Identification (UDI) labeling rule. Orthopedics company Globus Medical Inc. recently sent a Citizen Petition to the agency asking for exemption from the rule for some of it implants.
FDA's UDI rule requires that a UDI be included on medical device packages and labels, though t...
