21 C.F.R. § 801.20 – Label to bear a unique device identifier.

(a) In general.
1. (1) The label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of this subpart and part 830 of this chapter.
2. (2) Every device package shall bear a UDI that meets the requirements of this subpart and part 830 of this chapter.
(b) Exceptions. Exceptions to the general rule of paragraph (a) of this section are provided by §§ 801.30, 801.45, and 801.128(f)(2), and § 801.55 provides a means to request an exception or alternative not provided by those provisions.

[78 FR 58818, Sept. 24, 2013]