This rule proposes to establish a unique device identification system to implement § 519(f) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices.
The FDA is amending its July 10, 2012, proposed rule as required by Section 614 of the Food and Drug Administration Safety and Innovation Act (FDASIA). This amendment requires modification of the timeframe for implementation of the proposed rule’s requirements as they apply to devices that are implantable, life-saving (life-supporting), or life sustaining.
Regulatory Impact Analysis
- Unique Device Identification System; Proposed Rule Amendment
- Unique Device Identification System; Proposed Rule (PDF – 563KB)
- Report: "Unique Device Identification (UDI) for Medical Devices," Eastern Research Group, Inc., May 2012
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- September 2013: Final Regulatory Impact Analysis of Unique Device Identification System