FDA Delays UDI Marking Implementation for Some Orthopedic Implants
Thursday, December 18, 2014
Source: Becker's Spine Review
There are additional delays for the unique device identifier requirements on single-use implantables.
The Food and Drug Administration said in a letter on Wedensday that some labelers of single-use implants will have until Sept. 24, 2016 to comply with the FDA's UDI marking requirements. The extra time will allow for implant sterilization before use to comply with the FDA's rules. The FDA originally required markings on the devices, but safety concerns led to changing requrieemnts so the markings could be on product packaging. Single-use devices are sometimes sterilized apart from the implantation process, according to the report, which means packaging is discarded.
AdvaMed successfully advocated on behalf of the device companies to delay requirement deadlines so companies can implement markings appropritley.