§ 801.30 - General exceptions from the requirement for the label of a device 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.

(a) In general. The following types of devices are excepted from the requirement of § 801.20; a device within one or more of the following exceptions is not required to bear a unique device identifier (UDI):

(1) A finished device manufactured and labeled prior to the compliance date established by FDA for § 801.20 regarding the device. This exception expires with regard to a particular device 3 years after the compliance date established by FDA for the device.

(2) A class I device that FDA has by regulation exempted from the good manufacturing practice requirements of part 820 of this chapter, exclusive of any continuing requirement for recordkeeping under §§ 820.180 and 820.198.

(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 § 801.20, and must bear a UDI.

(4) A device used solely for research, teaching, or chemical analysis, and not intended for any clinical use.

(5) A custom device within the meaning of § 812.3(b) of this chapter.

(6) An investigational device within the meaning of part 812 of this chapter.

(7) A veterinary medical device not intended for use in the diagnosis of disease or other conditions in man, in the cure, mitigation, treatment, or prevention of disease in man, or intended to affect the structure or any function of the body of man.

(8) A device intended for export from the United States.

(9) A device held by the Strategic National Stockpile and granted an exception or alternative under § 801.128(f)(2).

(10) A device for which FDA has established a performance standard under section 514(b) of the Federal Food, Drug, and Cosmetic Act and has provided therein an exception from the requirement of § 801.20, or for which FDA has recognized all or part of a performance standard under section 514(c) of the Federal Food, Drug, and Cosmetic Act and has included an exception from the requirement of § 801.20 within the scope of that recognition.

(11) A device packaged within the immediate container of a combination product or convenience kit, provided that the label of the combination product or convenience kit bears a UDI.

(b) National Drug Code (NDC) Numbers. If a combination product properly bears an NDC number on its label -

(1) The combination product is not subject to the requirements of § 801.20.

(2) A device constituent of such a combination product whose components are physically, chemically, or otherwise combined or mixed and produced as a single entity as described by § 3.2(e)(1) of this chapter is not subject to the requirements of § 801.20.

(3) Each device constituent of such a combination product, other than one described by § 3.2(e)(1) of this chapter, must bear a UDI on its label unless paragraph (a)(11) of this section applies.

(c) Exception for shipping containers. This rule does not require a UDI to be placed on any shipping container.

(d) The UDI of a class I device is not required to include a production identifier.

[78 FR 58818, Sept. 24, 2013]