21 CFR 830.50 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Medical Devices (Subpart A To § 898.14) — Unique Device Identification (§ 830.3 To § 830.360) — Requirements For A Unique Device Identifier (§ 830.10 To § 830.60) — Changes that require use of a new device identifier.

4 Aug 2016

(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.

21 CFR 830.50

[78 FR 55825, Sept. 24, 2013]