Unique Device Identification System

FDA is issuing regulations establishing a unique device identification system for medical devices. The recordkeeping, reporting, and third-party disclosure requirements referenced in the UDI regulation are imposed on any person who causes a label to be applied to a device, or who causes the label to be modified, with the intent that the device will be introduced into interstate commerce without any subsequent replacement or modification of the label. In most instances, the labeler would be the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler. This rule is intended to substantially reduce existing obstacles to the adequate identification of medical devices used in the United States. By making it possible to rapidly and definitively identify a device and key attributes that affect its safe and effective use, the rule would reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use.

The latest form for Unique Device Identification System expires 2023-02-28 and is listed under ICR 201912-0910-001.

Reporting (ongoing)

Federal Enterprise Architecture: Health - Consumer Health and Safety