§ 801.20 Label to bear a unique device identifier

(a) In general.

(1) The label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of this sub part and part 830 of this chapter .

(2) Every device package shall bear a UDI that meets the requirements of this sub part and part 830 of this chapter .

(b) Exceptions. Exceptions to the general rule of paragraph (a) of this section are provided by §§ 801.30 , 801.45 , and 801.128(f)(2) , and § 801.55 provides a means to request an exception or alternative not provided by those provisions.

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What FDA inspectors cite under § 801.20

Form FDA 483 observations citing this section, fiscal years 2023–2026 (Devices).

• Label to bear a unique device identifier 126

Warning letters citing § 801.20

24 FDA warning letters since 2017 cite this section ; the most recent:

• Peter Schiff Enterprises 26 Aug 2026
• Nipro Renal Solutions USA, Corporation 24 Jul 2026
• Specialty Health Products CO, LLC 7 Jul 2026
• BlephEx, LLC 3 Jun 2026
• Physitemp Instruments, LLC 12 Nov 2025
• Technological Medical Advancements LLC 26 Sept 2025
• The Richline Group, Inc. 25 Aug 2025
• Spectra Therapy, LLC 22 Jul 2025
• O3UV, LLC 7 Jul 2025
• Reset Technology Corporation 9 Jun 2025
• NeuroSync, Inc. 9 May 2025
• EpiCare Acquisitions, LLC 21 Mar 2025

FDA guidance that cites § 801.20

• Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry draft 25 Jun 2025
• Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff draft 7 Jan 2025
• Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency : Guidance for Industry and Food and Drug Administration Staff 5 Sept 2023
• 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 25 Jul 2022
• Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI): Guidance for Industry and Food and Drug Administration Staff 7 Jul 2021
• Unique Device Identification: Convenience Kits : Guidance for Industry and Food and Drug Administration Staff 26 Apr 2019
• Unique Device Identification: Direct Marking of Devices : Guidance for Industry and Food and Drug Administration Staff 17 Nov 2017
• Unique Device Identifier System: Frequently Asked Questions, Vol. 1 : Guidance for Industry and Food and Drug Administration Staff 20 Aug 2014
• Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff 13 Aug 2014

Amendment history

Federal Register documents that created or amended this section.

• 78 FR 58818 24 Sept 2013