Device intended to be implanted in the human body for more than 1 year

The term helps define which devices FDA can order to be tracked. Tracking only applies to devices that FDA has ordered, not to every implant.

Device intended to be implanted in the human body for more than 1 year means a device that is intended to be placed into a surgically or naturally formed cavity of the human body for more than 1 year to continuously assist, restore, or replace the function of an organ system or structure of the human body throughout the useful life of the device. The term does not include a device that is intended and used only for temporary purposes or that is intended for explantation in 1 year or less.

21 CFR, 821.3