§830.50. Changes that require use of a new device identifier.
21 C.F.R. § 830.50
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.
Whenever you create a new device package, you must assign a new device identifier to the new device package.
Notes, amendments, and revision history
Amendments
[78 FR 58825, Sept. 24, 2013]
Authority
Authority: 21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j, 371.
Source
Source: 78 FR 58823, Sept. 24, 2013, unless otherwise noted.
Amendments
[78 FR 58825, Sept. 24, 2013]