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Code of Federal Regulations Title 21. Food and Drugs § 21.830.300 Devices subject to device identification data submission requirements

Current as of October 02, 2022 | Updated by FindLaw Staff

(a) In general. The labeler of a device must provide the information required by this subpart for each version or model required to bear a unique device identifier (UDI).

(b) Voluntary submission of information. If a labeler voluntarily includes a UDI on the label of a device under § 801.40, the labeler may also voluntarily submit information concerning that device under this part.

(c) Exclusions. FDA may reject or remove any device identification data where:

(1) The device identifier submitted does not conform to § 830.20;

(2) The information concerns a device that is neither manufactured in the United States nor in interstate commerce in the United States,

(3) The information concerns a product that FDA determines is not a device or a combination product that includes a device constituent part,

(4) The information concerns a device or a combination product that requires, but does not have, FDA premarket approval, licensure, or clearance;

(5) A device that FDA has banned under section 516 of the Federal Food, Drug, and Cosmetic Act;  or

(6) FDA has suspended the accreditation of the issuing agency that operates the system used by the labeler.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.830.300 Devices subject to device identification data submission requirements - last updated October 02, 2022 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-830-300/

Read this complete Code of Federal Regulations Title 21. Food and Drugs § 21.830.300 Devices subject to device identification data submission requirements on Westlaw

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