@Regulatory: September 2012
Unique device identification system proposed rule
On July 10, 2012, the Food and Drug Administration (FDA) issued for comment a proposed regulation on a unique device identification (UDI) system for medical devices. The proposed regulation offers the opportunity for improving operations, traceability, and patient safety. On the surface, the proposed regulation appears straightforward in that medical devices that are deemed critical should be uniquely identified to improve traceability and ultimately patient safety. Three key benefits coming from the proposed regulation are:
- Adverse event identification and reporting
- Device authentication
- Recall management and traceability
Though seemingly simple in concept, full implementation can be difficult as the overall supply and distribution chain landscape is very complex for devices.
Download the PDF to learn more about the proposed regulation and our perspective.
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