FDA Releases Unique Device ID Rule, Addresses Many Concerns of Industry

The Food and Drug Administration Sept. 20 released a final rule requiring that most medical devices distributed in the U.S. carry a unique device identifier (UDI).

The final rule (FDA-2011-N-0090) will be published in the Federal Register Sept. 24 and will take effect Dec. 23. Depending on the risk of the device, labelers (usually manufacturers) will have from one to seven years to comply with the UDI system, the FDA said.

The final rule makes various changes from the proposal, many of which were suggested by medical device industry groups. The FDA said compliance with the rule’s requirements will cost ...