FDA Releases Final Rule Establishing UDI System for Tracking Medical Devices
On Friday, FDA issued a final rule establishing a unique device identification system for tracking medical devices. The first component of the UDI system created under FDA's final rule is a unique identifier assigned by manufacturers to track devices' lot or batch number, expiration date and manufacturing date. The second component is a public, searchable database administered by FDA -- called the Global Unique Device Identification Database -- that will serve as a reference catalogue for all devices that have an identifier.
- "FDA Issues Final Unique Device Identifier Rule" (Bowman, FierceHealthIT, 9/20).
- "Medical Devices Need Unique Identifiers Under U.S. Rules" (Edney, Bloomberg Businessweek, 9/20).
- "UDI Rule Is Here, but Is It Enough?" (Monegain, Healthcare IT News, 9/20).