Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 830.300: Devices subject to device identification data submission requirements.

(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.

Where this section sits in the code

Title 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H—MEDICAL DEVICES
PART 830—UNIQUE DEVICE IDENTIFICATION
Subpart E—Global Unique Device Identification Database

(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.

(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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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