The 2012 law called FDASIA extended FDA’s authorities in ways that could toughen the bite of inspections, and require greater transparency about the source of devices to improve the quality of post-market data and reduce medical errors. The Universal Device Identifier, like a car’s VIN provides important information about the pedigree of devices. Use of UDI will improve the quality of post-market data, improve recalls and enable firms to better trend information about how their devices are performing in the market. Implementing UDI presents great logistical challenges and depending on the device, may present more than a few alternative ways to accomplish the necessary identification steps. This panel will update current FDA plans for the rollout and implementation of the new UDI rule.
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