FDA 510(k) documentation includes shelf-life studies. If you want to claim a shelf-life span for your device, you’ll need to keep the necessary studies and reports on hand. Even if accelerated studies are acceptable, FDA usually prefers real-time stability studies. To confirm the safety and effectiveness, the FDA required the performance test to be conducted following the real-time/accelerated research.
If the device is supplied sterile, sterilization and packaging validations should be performed after the shelf-life term.