Now before I offer an answer to my eleventh hour hype, let me summarize what Jay Crowley, senior advisor for patient safety for the FDA, has outlined for all medical device manufacturers who want to ship or export to the United States.

As you are aware, the Unique Device Identification (UDI) system is the FDA’s proposed system for identifying medical devices in a standardized way. This will help any recall efforts, post market surveillance and adverse event reporting, and electronic health record documentation. Another bonus is for the supply chain management to help improve it’s ordering and distribution of products. At the end of the day, though, the main driver is patient safety.

The FDA will be publishing the proposed UDI system regulations in 2010 for all medical devices. This will create an analogous, standardized identification system for all medical devices and promote the use of data that can help manufacturers manage their products.

For those manufacturers of medical devices in the Class 3 category, you will have one year after the final ruling, Continue reading →