Description
Section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and section 614 of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) amended the Federal Food, Drug, and Cosmetic Act to add section 519(f), which directs FDA to publish regulations establishing a unique device identification system for medical devices. On September 24, 2013, FDA published a final rule establishing a unique device identification system (the UDI Rule). While some parts of the rule became effective on October 24, 2013 and some became effective on December 23, 2013, most requirements within the rule have later compliance dates, as will be explained in Section A.2. of this document. In developing the UDI Rule, FDA solicited input from a variety of stakeholders (e.g., manufacturers, global regulatory bodies, the clinical community, patient advocates) to ensure that as many perspectives were incorporated as possible.
Scope & Applicability
Product Classes
9Products subject to the unique device identification system
Medical devices intended to benefit patients in the treatment or diagnosis of diseases affecting not more than 8,000 individuals in the U.S. per year.; Devices intended for diseases occurring in fewer than 8,000 individuals; devices approved under an HDE
Subject to General Controls
Not required to be directly marked with a UDI.
Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
Low risk medical devices
Specific UDI compliance dates and exception restrictions
Reusable life-supporting or life-sustaining devices issued an EUA; Devices like ventilators requiring specific transition steps
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.
Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
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.
Entity responsible for specifying acceptance criteria and risk management; Responsible for specifying essential performance and submitting premarket submissions.; supplied by the device manufacturer to the testing laboratory
A type of entity that may be considered a labeler.
A type of entity that may be considered a labeler.
A type of entity that may be considered a labeler.
Trading partner defined in section 581(16) of the FD&C Act
Entity that receives drug products for relabeling.
Regulatory Context
Attributes
1YYYY-MM-DD format required on labels
Related CFR Sections (11)
- 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 →
- 21CFR801.30§ 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 →
- 21CFR801.40§ 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 →
- 21CFR801.45§ 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 →
- 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 →
- 21CFR801.3§ 801.3 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 →
- 21CFR801.20§ 801.20 Label to bear a unique device identifier.
(a) In general.Read full regulation →
- 21CFR801.15§ 801.15 Medical devices; prominence of required label statements; use of symbols in labeling.
(a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 502(c) of the act by reason, among other reasons, of: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 →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
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.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-30
Medical Device Reporting/Misbranded
Insung Medical Co. Ltd.
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, 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 Identifier Requirements for Combination Products: Draft Guidance for Industry (Status: Draft)
- 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)
- Suggested Format For IDE Progress Report (Status: Final)
- Variance from Manufacturer Report Number Format [MDR letter] (Status: Final)
- Impact-Resistant Lenses: Questions and Answers: Guidance for Industry and FDA Staff (Status: Final)