Description
FDA’s unique device identification system includes unique device identifier (UDI) labeling (21 CFR 801.20) and data submission requirements (21 CFR 830.300). The unique device identification system regulations require that the label and device package of a device must bear a UDI, unless an exception or alternative applies. An exception is provided at 21 CFR 801.30(a)(11) for devices packaged within the immediate container of a convenience kit, if the label of the convenience kit bears a UDI.
Scope & Applicability
Product Classes
5Low risk medical devices
Devices packaged together to facilitate a single surgical or medical procedure
Products 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.
IVD device clinical studies conducted on de-identified specimens
Two or more different medical devices packaged together for the convenience of the user.
Stakeholders
2patient, caregiver, physician, nurse, pharmacist involved in medication use
Person who causes a label to be applied or modified; The entity responsible for submitting information to GUDID.; Entity responsible for identifying device constituent parts
Regulatory Context
Attributes
1Any device or accessory suitable for use or capable of functioning
Related CFR Sections (8)
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part: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 →
- 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 →
- 21CFR801.30§ 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 →
- 21CFR801.55§ 801.55 Request for an exception from or alternative to a unique device identifier requirement.
(a) A labeler may submit a request for an exception from or alternative to the requirement of § 801.20 or any other requirement of this subpart for a specified device or a specified type of device. A written request for an exception or alternative must:Read full regulation →
- 21CFR801.3§ 801.3 Definitions.
As used in this part:Read full regulation →
- 21CFR830.300§ 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).Read full regulation →
- 21CFR801.20§ 801.20 Label to bear a unique device identifier.
(a) In general.Read full regulation →
Related Warning Letters (5)
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 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.
- 2020-07-21
CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded
Centurion Medical Products Corporation
See Also (8)
- Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers (Status: Final)
- Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry (Status: Draft)
- Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff (Status: Draft)
- 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)
- Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: 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)