FDA Medical Device Accessory Packaging Requirements

robert.beck

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thanks for this interesting comment. this arose with a package that contains six individual items that are sent to and used by the same patient. each item is single use but not all six are necessarily from the same lot. each item is labeled with its lot. since complete UDIs are not required, is it reasonable to assume that complete, automatic traceability is not required, and it is ok to not track which lots go into each package?
 
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