Shelf-life

Shelf-life has to be supported by evidence such as real-time or accelerated aging data covering packaging and sterility as well as device function. Changing it can affect regulatory submissions, which is why the FDA 510(k) change guidance defines the term.

period of time until the expiry date during which a medical device or accessory (3.1) in its original packaging maintains its stability under the conditions specified in the information supplied by the manufacturer [SOURCE: IMDRF/GRRP WG/N52: 2019[4], 3.36, modified — replaced ‘by the manufacturer’ with ‘in the information supplied by the manufacturer’.]

ISO 20417:2021, clause 3.24

The term or period during which a device remains suitable for its intended use. This period ends at the device’s expiration date.

FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017), Appendix C, Significant Terminology