Unique Device Identification: Direct Marking of Devices : Guidance for Industry and Food and Drug Administration Staff

Description

This documentwill assist industry, particularly labelers, as defined under 21 CFR 801.3, and FDA staff in understanding FDA’s requirements for direct marking of devices for unique device identification purposes. Under 21 CFR 801.45, "[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." This guidance defines some terms used in the Agency’s regulations pertaining to the UDI direct marking requirements, including how FDA interprets the term "intended to be reprocessed" as used in 21 CFR 801.45. For additional background on the UDI system, see the Unique Device Identification System Final Rule, published on September 24, 2013 (78 FR 58786) (the UDI Rule -https://www.gpo.gov/fdsys/pkg/FR-2013-09-24/pdf/2013-23059.pdf).

Scope & Applicability

Regulatory Context

• 21CFR801.3§ 801.3 Definitions.

  As used in this part: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 →

• 21CFR801.45§ 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 →

• 21CFR801.40§ 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 →

• 21CFR801.30§ 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 →

• 21CFR801.20§ 801.20 Label to bear a unique device identifier.

  (a) In general.Read 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 →

• 21CFR807.81§ 807.81 When a premarket notification submission is required.

  (a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →

• 21CFR814.39§ 814.39 PMA supplements.

  (a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which FDA, under paragraph (e) of thRead full regulation →

• 21CFR601.12§ 601.12 Changes to an approved application.

  (a) General.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 →

• 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 →

• 21CFR830.20§ 830.20 Requirements for a unique device identifier.

  A unique device identifier (UDI) must: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 →

• CGMP/QSR/Medical Devices/Adulterated

  DFI Co., Ltd.

  2025-06-03

• CGMP/QSR/Medical Devices/Adulterated

  NeuroSync, Inc.

  2025-05-20

• CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded

  ICU Medical

  2025-04-22

• CGMP/QSR/Medical Devices/Adulterated

  EpiCare Acquisitions, LLC

  2025-04-08

• CGMP/QSR/Medical Devices/Adulterated

  Owens & Minor, Inc. dba American Contract Systems, Inc.

  2024-11-12

• CGMP/QSR/Medical Devices/Adulterated

  Rolence Ent. Inc.

  2024-11-08

• CGMP/QSR/Medical Devices/Adulterated/Misbranded

  Argon Medical Productions & Vertrieb Gesellschaft MBH & CO

  2024-10-29

• CGMP/QSR/Medical Devices/Adulterated

  Wissner-Bosserhoff GmbH

  2024-09-03

• CGMP/QSR/Medical Devices/Adulterated

  Jiangsu Shenli Medical Production Co., Ltd.

  2024-07-18

• CGMP/QSR/Medical Devices/Adulterated/Misbranded

  Techlem Medical Corporation

  2024-06-04

• Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
• Unique Device Identifier System: Frequently Asked Questions, Vol. 1 : 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 System: Form and Content of the Unique Device Identifier (UDI): 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)
• Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry (Status: Draft)
• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)