Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry | Guideline Explorer

Description

This document is intended to assist industry and FDA staff in understanding how FDA’s unique device identifier (UDI) requirements at 21 CFR part 801 subpart B and part 830 subpart E apply to combination products with device constituent parts. This guidance outlines the requirements, recommendations, and best practices for UDI labeling and for submission of information to the Global Unique Device Identification Database (GUDID) for such combination products. This guidance also provides hypothetical examples to illustrate how UDI requirements can be met for these combination products.

Scope & Applicability

Product Classes

8

Combination Product

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.

Class I device

Device category that may be exempt from certain UDI requirements if GMP exempt.

Drug-led combination product

Products that properly bear an NDC and are not required to bear a UDI.

Device-led combination product

Products that must bear a UDI and should not bear an NDC.

Single-Entity Combination Product

Physically or chemically combined components like prefilled syringes; Required to bear UDI unless it bears an NDC.; A combination product where components are physically or chemically combined

Co-Packaged Combination Product

Separate products packaged together in a single unit; Compliance options include UDI on the product or NDC plus UDI on device parts.; A combination product where components are packaged together

Cross-Labeled Combination Product

Separately packaged products intended for use only with each other; Constituent parts are separately distributed; device parts require UDI.; A combination product where components are packaged separately but labeled for use together

Device Convenience Kit

Two or more different medical devices packaged together.; Mentioned in recommendations for co-packaged products

Stakeholders

1

Labeler

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

3

Lot or batch

Production identifier element

Serial number

Production identifier element

Expiration date

should be based on appropriate supportive stability data

Related CFR Sections (10)

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 →
21CFR880.6430§ 880.6430 Liquid medication dispenser.
(a) Identification. A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication.Read full regulation →
21CFR801.20§ 801.20 Label to bear a unique device identifier.
(a) In general.Read full regulation →
21CFR801.3§ 801.3 Definitions.
As used in this part:Read full regulation →
21CFR830.20§ 830.20 Requirements for a unique device identifier.
A unique device identifier (UDI) must: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 →
21CFR801.55§ 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 →
21CFR4.2§ 4.2 How does FDA define key terms and phrases in this subpart?
The terms listed in this section have the following meanings for purposes of this subpart:Read 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 →
21CFR830.300§ 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 →

Related Warning Letters (10)

CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
2025-10-28
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
2025-10-21
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
2025-10-07
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
2025-09-23
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
2025-09-16
CGMP/QSR/Medical Devices/Adulterated
Miach Orthopaedics
2025-08-26