Makers of high-risk medical devices would be required to include on product packaging a unique identifying code linked to a new FDA-run database by about May 2014 under a regulation proposed by FDA July 3.
The mandate will extend to class II, moderate-risk devices two years later, and to some low-risk class I devices two years after that. For certain products, including most implantable devices, the unique device identifier (UDI) codes will also need to be etched directly onto devices, not just on the labels, with an additional two-year lag on implementation, according the long-awaited
