The FDA’s Center for Devices and Radiological Health (CDRH) has set a time line for release of the Unique Device Identification system. By September 30, 2013, the CDRH says it will launch the system for identifying and tracking all medical devices.
One of the CDRH’s responsibilities includes regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. A pilot study was started in August of last year to determine the feasibility of collecting and storing UDI data from the supplier to the product’s point of use at five hospitals. The UDI database pilot study is expected to be completed by September 2010.
The CDRH’s new director Jeffrey Shuren has set new strategic priorities for 2010 and for the following years. The changes include an overhaul of the 510(k) system, which requires that a new model of a device be compared for safety and effectiveness with another lawfully marketed model. A successful 510(k) submission results in FDA permission to market the new device. Part of the overhaul includes implementing the UDI system.
For a complete description of the CDRH and its strategic priorities for FY 2010, visit the U.S. FDA website.