No Defined Shelf Life/Expiration Date - Disposable single-use, non-invasive, non-sterile

#1
The product in question is disposable single-use, non-invasive, non-sterile. This product in the past would have been considered an unclassified accessory. There is no guidance on this accessory and no corresponding product code.

My question is whether or not we need shelf life data or if a justification/rationale would be sufficient? The materials are known as non-degradable and there are no foreseeable environmental/storage conditions that would lead to any sort of breakdown affecting safety or effectiveness. For labeling would manufacturing date and no expiration date be sufficient?
 

yodon

Staff member
Super Moderator
#3
I don't know the answer to your specific question, but...

Do you have all this documented in your Risk File? Also consider transport conditions and excursions from normal storage temperature ranges.
 

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