We have a next generation device on the market. Next generation device was released in August 2007. We are still receiving back used devices, which failed during a procedure and require investigations. The devices coming back have Lot Numbers (from the old generation devices) that have already surpassed the shelf life (expired). Per FDA guideline, do we as a device manufacturer still have to perform thorough investigations on those "used" expired products or can we just create a one-page letter stating that since the shelf life has expired, it will be redundant to perform a thorough investigation. In addition, the next generation device should correct the failure mode that was seen in the expired returned/used device(s).
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