Description
FDA published a final rule establishing a unique device identification system (UDI Rule) on September 24, 2013. It requires the labels and device packages of medical devices distributed in the United States include a unique device identifier, unless we grant an exception or alternative to UDI label requirements. The UDI Rule also requires specified product information be submitted to FDA’s Global Unique Device Identification Database (GUDID). This guidance document provides the FDA's recommendations on the information necessary for labelers submitting data to GUDID. FDA has updated this document to reflect changes to the Global Medical Device Nomenclature (GMDN) field in GUDID. The option to use FDA Preferred Terms (FDA PT) Codes will be removed because FDA PT codes are no longer necessary since GMDN Terms are now available without a paid membership.
Scope & Applicability
Product Classes
4Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
IVDs requiring UDI on labels
Human cells, tissues, and cellular and tissue-based products regulated as devices; Human cells, tissues, and cellular and tissue-based products regulated as medical devices; Human Cell, Tissue or Cellular or Tissue-Based Product
Device category that may be exempt from certain UDI requirements if GMP exempt.
Stakeholders
9Person who causes a label to be applied to a device for commercial distribution; Entity required to enter DI and attribute information into GUDID; Entity responsible for GUDID account and device information; Responsible for ensuring DI record information is accurate and up-to-date.; Entity identified by a GUDID account; Entity responsible for GUDID data and recordkeeping.
Organization accredited by FDA to operate UDI issuance system
Entities submitting device information on behalf of labelers.
User role for Labeler Data Entry; Labeler Data Entry user responsible for record management; Labeler Data Entry user role.; Individual responsible for day to day entry into GUDID
User role responsible for managing GUDID account and LDE users; Role that creates LDE users; Responsible for management of the GUDID account
Individual serving as the point of contact to FDA on device identification matters; User role in GUDID account
User role responsible for managing GUDID account and LDE users
User responsible for data entry and management of device identification information
Company or individual authorized to submit GUDID information on behalf of the labeler
Regulatory Context
Attributes
8Information that should match premarket submissions
Attributes that require a new DI if changed
Attributes that require a new DI if changed after grace period
Determines when a record moves to the Published state; Attribute determining when a DI record is public.
A 7-calendar day period after publication where most attributes can be edited.; 7-day window after publication for editing attributes; Timeframe during which DI record attributes are editable.
Indicates if a package is In Commercial Distribution or Not In Commercial Distribution.; State of the package in commercial distribution
Date a particular package configuration is discontinued
Attribute determining if a device is no longer offered for sale; Determines the Commercial Distribution Status of a device.
Related CFR Sections (16)
- 21CFR830.60§ 830.60 Relabeling of a device that is required to bear a unique device identifier.
If you relabel a device that is required to bear a unique device identifier (UDI), you must:Read full regulation →
- 21CFR807.28§ 807.28 Updating device listing information.
(a) Updating of device listing information is required if an additional establishment begins to engage in any of the activities described in § 807.3(d) with respect to a listed device, such as manufacturing, developing specifications, repackaging, relabeling, or otherwise processing the device. UpdaRead full regulation →
- 21CFR830.3§ 830.3 Definitions.
As used in this part:Read full regulation →
- 21CFR801.30§ 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):Read full regulation →
- 21CFR830.360§ 830.360 Records to be maintained by the labeler.
(a) Each labeler shall retain, and submit to FDA upon specific request, records showing all unique device identifiers (UDIs) used to identify devices that must bear a UDI on their label, and the particular version or model associated with each device identifier. These records must be retained for 3 Read full regulation →
- 21CFR830.330§ 830.330 Times for submission of unique device identification information.
(a) The labeler shall submit to FDA the information required by § 830.310 no later than the date the label of the device must bear a unique device identifier under § 801.20 of this chapter .Read full regulation →
- 21CFR830.50§ 830.50 Changes that require use of a new device identifier.
(a) Whenever you make a change to a device that is required to bear a unique device identifier (UDI) on its label, and the change results in a new version or model, you must assign a new device identifier to the new version or model.Read full regulation →
- 21CFR830.310§ 830.310 Information required for unique device identification.
The contact for device identification designated under § 830.320(a) shall provide FDA with the following information concerning each version or model of a device required to bear a unique device identifier (UDI) on its label:Read full regulation →
- 21CFR801.20§ 801.20 Label to bear a unique device identifier.
(a) In general.Read full regulation →
- 21CFR1271.290§ 1271.290 Tracking.
(a) General. If you perform any step in the manufacture of an HCT/P in which you handle the HCT/P, you must track each such HCT/P in accordance with this section, to facilitate the investigation of actual or suspected transmission of communicable disease and take appropriate and timely corrective acRead full regulation →
- 21CFR801.40§ 801.40 Form of a unique device identifier.
(a) Every unique device identifier (UDI) must meet the technical requirements of § 830.20 of this chapter . The UDI must be presented in two forms:Read full regulation →
- 21CFR830.320§ 830.320 Submission of unique device identification information.
(a) Designation of contact for device identification. Each labeler must designate an individual to serve as the point of contact with FDA on matters relating to the identification of medical devices marketed by the labeler. The contact for device information is responsible for ensuring FDA is providRead full regulation →
- 21CFR830.40§ 830.40 Use and discontinuation of a device identifier.
(a) Only one device identifier from any particular system for the issuance of unique device identifiers (UDIs) may be used to identify a particular version or model of a device. A particular version or model may be identified by UDIs from two or more systems for the issuance of UDIs.Read full regulation →
- 21CFR801.45§ 801.45 Devices that must be directly marked with a unique device identifier.
(a) In general. A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.Read full regulation →
- 21CFR801.3§ 801.3 Definitions.
As used in this part:Read full regulation →
- 21CFR807.3§ 807.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act.Read full regulation →
Related Warning Letters (5)
- 2025-05-20
CGMP/QSR/Medical Devices/Adulterated
NeuroSync, Inc.
- 2024-10-29
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Argon Medical Productions & Vertrieb Gesellschaft MBH & CO
- 2023-11-14
CGMP/QSR/Medical Devices/Misbranded
Wello Inc.
- 2022-06-28
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Fagron Group B.V.
- 2020-05-05
CGMP/Dietary Supplement/Adulterated/Misbranded
Hawaii Pharm LLC
See Also (8)
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI): Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Draft: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Unique Device Identifier System: Frequently Asked Questions, Vol. 1 : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Unique Device Identification: Direct Marking of Devices : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Unique Device Identification: Convenience Kits : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff (Status: Draft)