By Marie Thibault
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 the rule is being phased in gradually, with different deadlines for different classes of devices. Companies have until September 24, 2015 to add a UDI to “implantable, life-supporting, and life-sustaining devices,” and until September 24, 2016 to put a UDI on labels and packages of Class II devices.
Globus Medical sells devices that must meet either of these two compliance dates, but has asked that FDA consider devices distributed but not yet sold by the deadlines to be exempt from the rule. The company explained in its petition, “UDI labeling would be applied to all products in accordance with the FDA schedule and existing inventory would be consumed without relabeling for UDI. The reason for this request is that the distribution model for orthopedic implants is unlikely to result in complete inventory consumption within the allotted three year post implementation deadline.”
