(e) The Center Director may rescind an exception or alternative granted under this section if, after providing an opportunity for an informal hearing as defined in section 201(x) of the Federal Food, Drug, and Cosmetic Act and under part 16 of this chapter, the Center Director determines that the exception or alternative no longer satisfies the criteria described in this paragraph (e) or that any safeguard or condition required under this paragraph (e) has not been met.
801.20 Label to bear a unique device identifier.
801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier.
801.35 Voluntary labeling of a device with a unique device identifier.
801.40 Form of a unique device identifier.
801.45 Devices that must be directly marked with a unique device identifier.
801.50 Labeling requirements for stand-alone software.
(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 SUBSEC 801.30, 801.45, and 801.128(f)(2), and
(a) In general. The following types of devices are excepted from the requirement of
(1) A finished device manufactured and labeled prior to the compliance date established by
(2) A class I device that
(3) Individual single-use devices, all of a single version or model, that are distributed together in a single device package, intended to be stored in that device package until removed for use, and which are not intended for individual commercial distribution. This exception is not available for any implantable device. The device package containing these individual devices is not excepted from the requirement of
(4) A device used solely for research, teaching, or chemical analysis, and not intended for any clinical use.
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