Description
This document is intended to assist labelers and FDA-accredited issuing agencies in complying with unique device identifier (UDI) labeling requirements, including by clarifying FDA’s interpretation of certain requirements under 21 CFR 801.40. Specifically, this guidance describes the requirements for and FDA’s recommendations regarding the form and content of the UDI to help ensure that the UDIs developed under systems for the issuance of UDIs meet the objectives of the Unique Device Identification System Final Rule, 78 FR 58786 (September 24, 2013) (UDI Rule).
Scope & Applicability
Product Classes
4Device category that may be exempt from certain UDI requirements if GMP exempt.
Device classification mentioned regarding novel sterilization methods
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
Software not part of a hardware medical device, subject to specific UDI labeling.
Stakeholders
2Person 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 a UDI issuance system; Entity that operates a system for UDI assignment; Organizations that provide guidelines for including non-UDI elements.
Regulatory Context
Attributes
4UDI provided on the device itself
Required label element for outsourcing facilities
Non-UDI element that may be included in the UDI carrier but is not part of the UDI.
Included in the definition of lot or batch for stand-alone software.
Related CFR Sections (9)
- 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 →
- 21CFR801.20§ 801.20 Label to bear a unique device identifier.
(a) In general.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 →
- 21CFR801.50§ 801.50 Labeling requirements for stand-alone software.
(a) Stand-alone software that is not distributed in packaged form (e.g., when downloaded from a Web site) is deemed to meet the UDI labeling requirements of this subpart if it complies with the requirements of paragraph (b) of this section and conveys the version number in its production identifier.Read full regulation →
- 21CFR830.20§ 830.20 Requirements for a unique device identifier.
A unique device identifier (UDI) must:Read full regulation →
- 21CFR801.3§ 801.3 Definitions.
As used in this part:Read full regulation →
- 21CFR830.3§ 830.3 Definitions.
As used in this part: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 →
- 21CFR801.18§ 801.18 Format of dates provided on a medical device label.
(a) In general. Whenever the label of a medical device includes a printed expiration date, date of manufacture, or any other date intended to be brought to the attention of the user of the device, the date must be presented in the following format: The year, using four digits; followed by the month,Read full regulation →
Related Warning Letters (4)
- 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
- 2024-07-09
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
AG Essence, Inc.
- 2023-11-14
CGMP/QSR/Medical Devices/Misbranded
Wello Inc.
See Also (8)
- Unique Device Identification System: Small Entity Compliance Guide: 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)
- Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry (Status: Draft)
- Unique Device Identifier System: Frequently Asked Questions, Vol. 1 : Guidance for Industry and Food and Drug Administration Staff (Status: Final)