Expiration date

Setting or extending an expiration date needs supporting data, usually from aging and stability studies. When the label carries an expiration date, it is also part of the UDI production identifier.

Expiration date means the date by which the label of a device states the device must or should be used. FDA, we, or us means the Food and Drug Administration.

21 CFR, 830.3

Expiration date means the date by which the label of a device states the device must or should be used. FDA, we, or us means the Food and Drug Administration.

21 CFR, 801.3

The date beyond which the product may cease to perform safely or effectively and beyond which the manufacturer states the product should not be used.

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

The two CFR definitions tie the expiration date to what the label states. The 510(k) change guidance describes it from the performance side, as the date beyond which the device may cease to perform safely or effectively.