Senate Bill Would Boost Flow of Device Supply Chain Data

April 20, 2012
The FDA would be required to implement a unique device identification (UDI) system by the end of 2013 if a new Senate bill becomes law. The bill also requires the agency’s Sentinel postmarket surveillance system to track device-related adverse events. The Ensuring Safe Medical Devices for Patients Act, S. 2193, was introduced March 15 by Sens. Jeff Merkley (D-Ore.), Chuck Grassley (R-Iowa), Michael Bennet (D-Colo.) and Herb Kohl (D-Wis.). The bill follows calls by several House members for congressional hearings on surgical mesh and metal-on-metal hip replacements — both the subject of ongoing safety concerns.
The GMP Letter