Shelf Life Isn’t Always Required on Medical Device Labels

Shelf Life Isn’t Always Required on Medical Device Labels

March 13, 2023

Shelf Life Isn’t Always Required on Medical Device Labels

 

FDA’s medical device label regulations at 21 CFR §801.18 include the language, “…Whenever the label of a medical device includes a printed expiration date…”, thereby leaving open the possibility that a medical device label might not include an expiration date.  In alignment with this, FDA’s shelf life guidance states, “…To determine if a particular device requires a shelf life and assign an expiration date, there are a number of different parameters that must be considered….For some devices…it is not reasonable to assign a shelf life…” [emphasis added.].  Accordingly, we can be confident that a shelf life isn’t always required on medical device labels.  Specifically, while sterile devices must always be labeled with a shelf life, it remains that non-sterile devices may not need one.

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