Source: https://casetext.com/regulation/code-of-federal-regulations/title-21-food-and-drugs/chapter-i-food-and-drug-administration-department-of-health-and-human-services-continued/subchapter-h-medical-devices/part-801-labeling/subpart-b-labeling-requirements-for-unique-device-identification/80130-general-exceptions-from-the-requirement-for-the-label-of-a-device-to-bear-a-unique-device-identifier?ref=AsVVwS!8pGNah
Timestamp: 2019-05-25 09:15:53
Document Index: 553269397

Matched Legal Cases: ['§ 801', '§ 801', '§ 801', '§ 801', 'ART 801', '§ 801', '§ 801', 'art 820', '§ 820', '§ 801', '§ 812', '§ 801', '§ 801', '§ 801', '§ 801', '§ 3', '§ 801', '§ 3', '§ 801', '§ 801']

§ 801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier, 21 C.F.R. § 801.30 | Casetext
21 C.F.R. § 801.30
§ 801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier
PART 801 - LABELING
Subpart B - Labeling Requirements for Unique Device Identification
(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.
(5) A custom device within the meaning of § 812.3(b) of this chapter.
(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.
(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.
§ 801.20 Label to bear a unique device identifier
§ 801.35 Voluntary labeling of a device with a unique device identifier