Newcastle University

FDA delays UDI labelling requirements

The FDA originally proposed requiring implantable medical devices to bear a unique device identification code on their surface. But industry protested that part of the proposed rule, so the agency ultimately opted to rely on packaging as the surface for UDIs. However, some orthopedics are removed from their packaging well before surgery or implantation, forcing the FDA to make a change on the fly

The agency delayed the UDI labeling deadline by two years to Sept. 24, 2016, for single-use orthopedics that are intended to be sterilized before use.

Read more here.

Last modified: Tue, 03 Mar 2015 14:15:45 GMT

MetalHip Newcastle: metalhip@ncl.ac.uk; +44 191 2083261

School of Mechanical & Systems Engineering, Stephenson Building, Newcastle University, Newcastle upon Tyne, NE1 7RU, United Kingdom