Current through June 30, 2022
Section 801.20 - Label to bear a unique device identifier(a)In general.(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) 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 , and §801.55 provides a means to request an exception or alternative not provided by those provisions.