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.