I’d be curious if anyone is ‘in the know’ on awareness of any general strategy for compliance to the UDI ruling for non-sterile implantables (such as spinal implants) ? The FDA gave us an extension to Sep 2016 to implement, but there is no real clear “solution” for how or what exactly to implement. I attended FDA’s UDI Conference in Baltimore a few months ago but it did not shed much light. I know the larger players are working on certain solutions of their own, but even they did not have all the answers, nor were the solutions I saw complete, last I checked. I even wondered about possible licensing/buying of solutions, maybe from these larger players, and I was told the FDA was working on some means to manage that possibility. Request to FDA’s Help Desk have gone unacknowledged to this point. The other puzzling thing to me is it seems that the hospitals need to be in this loop as well, since whatever solutions the medical device companies come up with, one would think it would need to be harmonized with each hospital’s procedures for sterilization, etc. Last I checked with AdvaMed, I did not get much clarity, as it did not appear that they were leading any “common” resolution. Curious if anyone has any inside knowledge or suggestions.

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