21 CFR 830.50 – Changes that require use of a new device identifier
Current as of: 2024 | Check for updates
|
Other versions
(a) Whenever you make a change to a device that is required to bear a unique device identifier (UDI) on its label, and the change results in a new version or model, you must assign a new device identifier to the new version or model.
(b) Whenever you create a new device package, you must assign a new device identifier to the new device package.