§ 830.50. Changes that require use of a new device identifier.
71 words·~1 min read·
/us/cfr/t21/s§ 830.50·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [78 FR 58825, Sept. 24, 2013]