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Unique Device Identification

Unique Device Identification (UDI) is a regulatory system established by the U.S. Food and Drug Administration (FDA) that assigns a unique numeric or alphanumeric code to medical devices, facilitating their precise identification from manufacturing through distribution, clinical use, and patient care.^[1] The UDI system was mandated under Section 303 of the [Food and Drug Administration](/page/Food and Drug Administration) Safety and Innovation Act (FDASIA) and finalized in a rule published on September 24, 2013, with an effective date of December 23, 2013.^[2] Its primary purpose is to improve patient safety by enhancing the tracking of medical devices, streamlining product recalls, accelerating adverse event investigations, and reducing medication errors associated with device misidentification.^[2] A UDI comprises two main components: the device identifier (DI), a fixed portion that specifies the labeler and the specific version or model of the device, and the production identifier (PI), a variable portion that may include the lot or batch number, serial number, expiration date, or date of manufacture, depending on the device type.^[1] These identifiers must appear on device labels and packages in both easily readable plain-text format and an automatic identification and data capture (AIDC) technology, such as barcodes or RFID, to enable machine-readable scanning.^[1] For reusable or reprocessed devices, a permanent UDI marking directly on the device itself is also required.^[2] Implementation of the UDI rule occurs in phases based on device risk classification: Class III devices (highest risk) by September 24, 2014; implantable, life-sustaining, or Class III devices by September 24, 2015; Class II devices by September 24, 2016; and Class I devices by September 24, 2018.^[2] Labelers—entities responsible for labeling devices—are required to submit key identification data to the FDA's publicly accessible Global Unique Device Identification Database (GUDID), which supports postmarket surveillance without disclosing proprietary information.^[1] Exceptions apply to certain low-risk devices, custom-made products, investigational devices, and those for export or in the Strategic National Stockpile.^[2] The system relies on FDA-accredited issuing agencies, such as GS1, HIBCC, and ICCBBA, to generate compliant UDIs using standardized formats like GS1-128 barcodes.^[1] By promoting standardized identification, UDI enhances interoperability across the healthcare supply chain and supports global harmonization efforts in medical device regulation.^[1]

Introduction

Definition and Purpose

Unique Device Identification (UDI) is a standardized system that assigns a unique numeric or alphanumeric code to medical devices, required on their labels and packages to identify the specific device and key production details throughout its lifecycle from manufacturing to patient use.^[1]^[3] This code enables unambiguous identification, distinguishing one device from another even if they share similar characteristics, and is mandated by regulatory authorities in major regions such as the United States and the European Union to ensure consistent application across global supply chains.^[4]^[3] The primary purposes of UDI include enhancing patient safety through rapid and precise device identification during adverse events, which allows healthcare providers to quickly access critical information and respond effectively.^[5] It also facilitates post-market surveillance by enabling regulators and manufacturers to track device performance, analyze trends in adverse events, and initiate timely recalls or corrections to mitigate risks.^[5]^[6] Additionally, UDI reduces medical errors by providing clear, standardized labeling that minimizes confusion in clinical settings and supports supply chain efficiency through better inventory management, counterfeiting prevention, and streamlined distribution.^[5]^[3] UDI codes are linked to centralized databases where manufacturers submit device-specific data, allowing real-time access to attributes such as device version or model, manufacturer details, and other static identification information to support ongoing monitoring and decision-making.^[1]^[3] In the United States, this information is stored in the Global Unique Device Identification Database (GUDID), while the European Union maintains an electronic UDI database for similar purposes.^[7]^[6] UDI applies to most medical devices on the market but excludes custom-made devices and investigational devices unless otherwise specified by regulators.^[8]^[3]

Historical Development

The development of Unique Device Identification (UDI) originated in the early 2000s amid growing concerns over medical device safety and traceability, spurred by high-profile recalls and legislative efforts to enhance postmarket surveillance. The Food and Drug Administration Amendments Act (FDAAA) of 2007 marked a pivotal moment by directing the FDA to establish a UDI system to improve device identification throughout the supply chain and facilitate rapid responses to adverse events. This built on earlier frameworks like the Safe Medical Devices Act of 1990, with amendments in the 2000s emphasizing better tracking to prevent incidents such as the 2008 heparin contamination crisis, which involved adulterated raw materials from China and led to over 800 adverse events and at least 81 deaths, underscoring the need for standardized identification to mitigate supply chain risks.^[9]^[10] A key milestone came in 2013 when the FDA issued its final rule establishing the UDI system, requiring devices to bear a unique identifier on labels and packages to enable tracking from manufacturing to patient use.^[2] Compliance began in September 2014 for high-risk (Class III) devices, with phased implementation for lower-risk classes culminating in Class I devices by September 24, 2018, although the FDA later extended enforcement discretion for certain Class I devices beyond that date.^[11] Internationally, the Global Harmonization Task Force (GHTF), predecessor to the International Medical Device Regulators Forum (IMDRF), endorsed UDI principles in 2011 through its guidance on a globally harmonized system for medical device identification, promoting adoption beyond the U.S. to address counterfeit and substandard products.^[12] The European Union's Medical Device Regulation (MDR) in 2017 further advanced UDI by mandating its use for all devices to enhance traceability and market surveillance, aligning with global standards while introducing requirements for registration in the European database on medical devices (EUDAMED). Post-2020, efforts intensified amid the COVID-19 pandemic's supply chain disruptions, with the IMDRF issuing 2019 guidance on UDI application to support harmonized implementation, followed by updates through 2025 focusing on digital integration for real-time tracking.^[13] By 2025, the FDA's Global Unique Device Identification Database (GUDID) contained over 4 million records, contributing to tens of millions of UDIs registered globally and enabling more efficient recall management and safety monitoring.^[14]

UDI System Components

Device Identifier

The Device Identifier (DI), also referred to as the UDI-DI, is the mandatory, fixed portion of the Unique Device Identification (UDI) that specifies the labeler—typically the manufacturer—and the particular version or model of a medical device.^[1]^[2] Manufacturers assign the DI through FDA-accredited issuing agencies, such as GS1, HIBCC, or ICCBBA, ensuring it links directly to regulatory databases containing essential device attributes, including the make, model, and sterile status.^[1]^[15]^[16] The structure of the DI is a numeric or alphanumeric code that varies by issuing agency but is designed for global interoperability.^[2] In GS1 systems, it follows the Global Trade Item Number (GTIN) format, comprising 14 digits: a company prefix (variable length, typically 6-11 digits assigned to the manufacturer), an item reference (specific to the device model), and a check digit for validation.^[15]^[16] For example, a GS1-based DI might appear as "(01)00812345001234", where the 14 digits represent the GTIN (e.g., company prefix "00812345", item reference, and check digit).^[15]^[16] GS1 DIs are numeric and 14 characters long (excluding the application identifier). Other agencies use alphanumeric formats: HIBCC (6-23 characters), ICCBBA (10-16 characters).^[16] The DI plays a critical role in establishing global uniqueness for device models, facilitating database queries—such as to the FDA's Global Unique Device Identification Database (GUDID)—without relying on production-specific details like lot numbers.^[1]^[15] It must appear on all device labels and higher-level packaging in both human-readable plain-text format and machine-readable automatic identification and data capture (AIDC) technology, such as barcodes or RFID.^[2] The full UDI is formed by appending the variable Production Identifier (PI) to the DI.^[1] A key characteristic of the DI is its version-specific nature: a new DI must be issued for any design or manufacturing change that creates a distinct version or model, particularly those impacting safety, performance, or intended use, such as alterations to clinical size, sterility requirements, or critical warnings.^[17]^[2] This ensures precise identification and traceability throughout the device lifecycle.^[17]

Production Identifier

The Production Identifier (PI) is the conditional, variable portion of a Unique Device Identifier (UDI) that identifies one or more dynamic production details, including the lot or batch number, serial number, expiration date, manufacturing date, or a distinct identification code required for human cells, tissues, and cellular and tissue-based products (HCT/P) regulated solely as devices.^[1] This component contrasts with the fixed Device Identifier (DI) by capturing information specific to individual units or batches rather than the device model itself.^[1] In the structure of a full UDI, the PI is appended directly after the DI and follows standardized formats defined by FDA-accredited issuing agencies, such as GS1, HIBCC, or ICCBBA.^[16] For instance, in GS1 format, PI elements are prefixed with application identifiers (AI) enclosed in parentheses, like (17) for expiration date or (10) for lot number, with dates typically formatted as YYMMDD.^[16] A representative example of a complete UDI is (01)51022222233336(17)150707(10)A213B1, where (01)51022222233336 serves as the DI, (17)150707 denotes an expiration date of July 7, 2015, and (10)A213B1 indicates the lot number as a PI element.^[16] The PI facilitates enhanced traceability throughout the device lifecycle by linking specific production instances to the broader device identification, enabling precise recalls, efficient adverse event investigations, and improved post-market surveillance.^[1] It is required on labels only when applicable to the device type and risk class, making it optional for certain low-risk devices where variable production data is unnecessary. GUDID includes flags indicating which PI elements (e.g., lot number, expiration date) are present on the device label, but does not store specific PI values.^[1]^[1] The PI varies per unit or batch, ensuring differentiation even among identical device models produced in sequence.

Global Regulatory Frameworks

United States

The United States Food and Drug Administration (FDA) established the Unique Device Identification (UDI) system through a final rule issued on September 24, 2013, pursuant to Section 614 of the Food and Drug Administration Safety and Innovation Act, which amended Section 519(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This rule mandates that medical device labels and higher-level packages bear a UDI to facilitate identification throughout the device's distribution and use, with phased implementation based on device risk classification to enhance patient safety, improve postmarket surveillance, and support supply chain efficiency. The UDI comprises a static device identifier (DI) portion specifying the version or model and a variable production identifier (PI) portion conveying lot, serial, or expiration details as applicable. Compliance timelines were structured around device classes: Class III (highest risk) devices required UDI labeling by September 24, 2014, and direct marking where applicable by September 24, 2015; Class II devices followed with labeling by September 24, 2016, and direct marking by September 24, 2018; Class I (lowest risk) and unclassified devices had labeling deadlines of September 24, 2020, and direct marking by September 24, 2022. The FDA granted case-by-case extensions, including one-year deferrals for certain Class III and licensed devices upon request, and broader compliance policies for small businesses and low-risk Class I devices, extending some deadlines through December 2022 to accommodate resource constraints. Reusable devices intended for reprocessing must bear a permanent direct mark of the UDI, ensuring traceability across multiple uses. Labelers are required to submit key device attributes—such as the DI, proprietary and public device names, and risk classification—to the FDA's publicly searchable Global Unique Device Identification Database (GUDID) within specified timelines following labeling compliance. In June 2025, the FDA issued draft guidance clarifying UDI application to combination products (e.g., those integrating drug and device constituents), recommending UDIs on device-led co-packages while prohibiting them on single-entity parts to avoid confusion with National Drug Codes, and outlining GUDID submission protocols for such products. The framework adopts a risk-based prioritization, exempting very low-risk devices like bandages, dental floss, and examination gloves from UDI requirements if they present minimal potential for adverse events. The FDA enforces UDI compliance through routine inspections of manufacturing facilities and supply chains, issuing warning letters for deficiencies and escalating to civil penalties, product seizures, injunctions, or criminal prosecution for willful violations under the FD&C Act. As of February 2025, the GUDID held over 3 million device records, reflecting widespread adoption among labelers.

European Union

The Unique Device Identification (UDI) system in the European Union is incorporated into the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), which mandate that manufacturers assign a UDI to each device, including its packaging, prior to placing it on the market to enhance traceability and post-market surveillance.^[3] Under Article 27 of the MDR and Article 24 of the IVDR, the UDI consists of a device identifier (UDI-DI) and production identifier (UDI-PI), with the UDI carrier required in both human-readable interpretation (HRN) and automatic identification and data capture (AIDC) formats on the device label and all higher levels of packaging.^[18]^[19] This harmonized approach ensures consistent identification across the EU single market, facilitating the electronic submission of UDI-related device data to the European database on medical devices (EUDAMED).^[6] Compliance with UDI requirements is implemented in phases based on device risk class. For medical devices under the MDR, UDI assignment and carrier placement became mandatory for implantable devices and Class III devices on 26 May 2021, extended to Class IIa and IIb devices on 26 May 2023, and to Class I devices by 26 May 2025, with full rollout across all classes by 26 May 2027 for direct marking on reusable devices.^[20] Similarly, for in vitro diagnostic devices under the IVDR, which entered into force on 26 May 2022, UDI obligations apply to Class D devices from 26 May 2023, Class C and B from 26 May 2025, and Class A by 26 May 2027.^[20] Manufacturers must submit UDI and associated device information to EUDAMED's UDI/Devices module prior to market placement, with the module available for voluntary use since October 2021. As of November 2025, EUDAMED is in gradual rollout, with full functionality for the UDI/Devices module anticipated by late 2025 and mandatory submissions beginning in early 2026 for initial processes.^[21]^[20] A distinctive feature of the EU UDI system is the Basic UDI-DI (BUDI-DI), which serves as the primary access key in EUDAMED for grouping families of similar devices sharing the same basic design and characteristics, rather than identifying individual models.^[6] This grouping mechanism, referenced in certificates issued by notified bodies and technical documentation, streamlines regulatory oversight and data management.^[6] In 2025, updates to the system include the introduction of a Master UDI-DI for highly individualized devices such as contact lenses and spectacles under Commission Delegated Regulation (EU) 2025/1920, applicable from 1 November 2028, alongside EUDAMED's digital modules enhancing post-market surveillance through integrated electronic reporting and traceability interfaces.^[22]^[23]

Other Jurisdictions

In Australia, the Therapeutic Goods Administration (TGA) introduced a Unique Device Identification (UDI) regulatory framework in 2020, with regulations taking effect in March 2025 and mandatory compliance required for Class III and implantable Class IIb medical devices starting July 1, 2026.^[24] This system aligns with International Medical Device Regulators Forum (IMDRF) guidance, requiring manufacturers to include UDI on labels, packaging, and direct markings where applicable, while sponsors submit UDI data to the Australian Register of Therapeutic Goods (ARTG) database to enhance traceability and post-market surveillance.^[25] Health Canada proposed a UDI system for medical devices in June 2021, building on earlier consultations from 2020, with implementation initially voluntary to allow stakeholder preparation.^[26] As of 2025, the system remains voluntary, but Health Canada has indicated plans for a phased mandatory rollout beginning in 2025 for high-risk Class III and IV devices, followed by lower-risk classes, to improve adverse event reporting and supply chain management without a finalized timeline for full enforcement.^[27] In China, the National Medical Products Administration (NMPA) mandated UDI for all Class III medical devices starting June 1, 2022, following pilot phases in 2021, with requirements extending to select Class II devices via catalogs released in 2022 and ongoing expansions.^[28] The rules stipulate UDI inclusion on labels, instructions, and packaging, with data submission to the NMPA's UDI database, aiming to standardize identification and facilitate recalls.^[29] Brazil's National Health Surveillance Agency (ANVISA) established UDI requirements through Resolution RDC 591/2021, with updates via RDC 884/2024 effective June 2024, initiating a phased approach that mandates UDI labeling for Class IV (high-risk) devices from July 10, 2025, and progressing to lower classes by 2030.^[30] Manufacturers must apply UDI carriers on products and submit data to ANVISA's UDI database, promoting interoperability with global standards while addressing local market needs.^[31] Japan's Pharmaceuticals and Medical Devices Agency (PMDA) implemented mandatory UDI labeling through amendments to the Pharmaceuticals and Medical Devices Act effective in 2019, requiring identification on device labels and packages for most medical devices, with exceptions for low-risk items.^[32] As of 2025, the system emphasizes voluntary data submission to support post-market safety, though full mandatory database integration remains under development to align with IMDRF principles.^[33] The IMDRF's 2013 foundational UDI guidance, supplemented by the 2019 System Application Guide, has influenced over 20 countries and economies, including members like Australia, Brazil, Canada, China, Japan, Singapore, South Korea, and Saudi Arabia, by providing a harmonized framework for UDI structure, carriers, and databases to reduce variations in global adoption.^[13] The World Health Organization (WHO) endorses UDI principles through its support for medical device regulation in low- and middle-income countries, advocating adaptable implementations to improve access and safety in resource-limited settings via technical guidance on essential medicines and technologies. By 2025, more than 15 jurisdictions worldwide, including the United States, European Union, China, South Korea, Saudi Arabia, Australia, and Brazil, have established UDI mandates or phased requirements, yet interoperability challenges persist due to differences in data formats, issuing agencies, and database access, hindering seamless global supply chain integration.^[33]^[34]

Standards and Implementation

Issuing Agencies and Standards

Unique Device Identification (UDI) relies on accredited issuing agencies that operate standardized systems to assign identifiers, ensuring global consistency and interoperability for medical devices. The primary FDA-accredited issuing agencies include GS1, which utilizes Global Trade Item Numbers (GTINs) as the basis for device identifiers and is the most widely adopted for general medical devices; the Health Industry Business Communications Council (HIBCC), specializing in healthcare-specific barcodes for provider and supplier identification; and the International Council for Commonality in Blood Banking Automation (ICCBBA), focused on unique identification for blood products and related devices.^[35]^[16]^[15] These agencies adhere to international standards that define the structure and requirements for UDIs. The ISO/IEC 15459 series provides the foundational framework for unique identification, with ISO/IEC 15459-2 specifying procedural requirements for registration authorities and issuing agencies, ISO/IEC 15459-4 for the content and formatting of unique identifiers for individual items to ensure they are globally unique and non-significant (i.e., not conveying additional product details beyond identification), and ISO/IEC 15459-6 for data structures supporting product groupings. Complementing these, the International Medical Device Regulators Forum (IMDRF) issues guidance to promote harmonization, outlining principles for UDI systems that facilitate regulatory convergence across jurisdictions while aligning with ISO standards.^[36]^[37]^[38]^[39] The issuance process begins with agencies assigning a unique company prefix to manufacturers upon registration, which forms the initial segment of the device identifier (DI) portion of the UDI; manufacturers then append version or model-specific elements to complete the DI, while production identifiers (PIs) are added for variable data like lot or expiration. Manufacturers must register their DIs with the relevant agency to obtain official assignment, ensuring traceability from production to distribution. This structured approach prevents identifier reuse or overlap across agencies.^[4]^[15]^[13] To maintain integrity, issuing agencies are subject to rigorous accreditation criteria, including mechanisms to guarantee non-duplication of identifiers through centralized registries and validation protocols, as well as periodic audits by regulatory bodies like the FDA to verify compliance with standards and processes. These requirements ensure the reliability of UDIs in global supply chains.^[16]

Labeling and Data Submission

Labeling requirements for Unique Device Identification (UDI) mandate that the identifier appear on the device label, packaging, and higher levels of packaging in both human-readable interpretation (HRI) format—typically enclosed in parentheses for clarity—and automatic identification and data capture (AIDC) format, such as linear barcodes or two-dimensional Data Matrix codes. This dual presentation ensures accessibility for manual reading and automated scanning throughout the supply chain. For reusable devices that cannot accommodate labels, direct marking is required directly on the device using durable methods like laser etching, engraving, or chemical etching to achieve permanence, adhering to standards outlined in ISO/IEC 15459-4 for resistance to environmental stresses and cleaning processes. Data submission involves manufacturers providing UDI and associated device attributes to centralized regulatory databases, including the U.S. Food and Drug Administration's (FDA) Global Unique Device Identification Database (GUDID), which is fully operational, and the European Union's European Database on Medical Devices (EUDAMED), which is in phased rollout as of 2025 with full functionality planned for 2027. These submissions encompass key details such as Global Medical Device Nomenclature (GMDN) codes for device classification and any critical warnings or safety information relevant to clinical use. Challenges persist with AIDC scanning, particularly for very small devices due to limited surface area and readability constraints.^[1] The submission process requires manufacturers to use designated portals: the GUDID web interface or Structured Product Labeling (SPL) files for the FDA, and the EUDAMED online system for the EU. In the United States, submissions must occur no later than seven calendar days after the device is first placed on the market, while in the EU, UDI assignment and data entry precede market placement to enable pre-market registration. Accredited issuing agencies, such as GS1 or HIBCC, provide the foundational UDI codes that facilitate these standardized submissions.

Benefits and Challenges

Advantages

Unique Device Identification (UDI) enhances traceability of medical devices throughout the supply chain, from manufacturing to patient use, enabling faster identification and response during recalls. By assigning a standardized identifier to each device, UDI allows regulators and manufacturers to pinpoint affected products with precision, significantly reducing the time required to implement and complete recalls compared to traditional methods reliant on lot numbers or descriptions.^[2] The U.S. Food and Drug Administration (FDA) notes that this rapid identification supports more efficient adverse event reporting and resolution, allowing problems to be addressed more quickly to protect public health.^[5] UDI contributes to patient safety by facilitating quick access to device-specific information, such as instructions for use, compatibility with patient allergies, and authenticity verification to detect counterfeits. Healthcare professionals can scan UDIs to retrieve critical data from databases like the FDA's Global Unique Device Identification Database (GUDID), reducing the risk of errors in device selection and administration.^[5] The European Commission highlights that UDI systems help mitigate medical errors and combat falsified devices, improving overall safety in clinical settings.^[3] In supply chain management, UDI enables automated inventory tracking through barcode or RFID scanning, streamlining logistics, reducing stock discrepancies, and minimizing waste from expired or misplaced devices. Studies indicate that the U.S. healthcare supply chain wastes up to $11 billion annually due to inefficiencies, which adopting standardized identification like UDI could help mitigate.^[40] Broader global standardization efforts, including UDI, could further cut data processing costs by 50-70%, contributing to $1-2 billion in annual efficiencies for U.S. healthcare operations.^[41] UDI strengthens post-market surveillance by providing structured data for risk analysis, enabling regulators to monitor device performance and identify patterns in adverse events more effectively. Integration of UDI into reporting systems improves the accuracy and completeness of incident data, leading to better-informed regulatory actions and a reduction in underreported issues.^[5] Finally, UDI promotes global interoperability by using standardized formats that align with international standards, such as those from GS1, facilitating seamless cross-border trade and emergency responses. This compatibility ensures devices can be tracked consistently across jurisdictions, aiding multinational recalls and supply chain coordination without the need for multiple identification systems.^[42]

Implementation Challenges

The implementation of Unique Device Identification (UDI) systems imposes significant cost burdens on manufacturers, particularly smaller entities with limited resources. According to FDA economic analyses, initial setup costs for small manufacturers (1-4 employees) include planning and administration expenses ranging from $1,455 to $3,982, with additional minimal equipment costs of about $450 for manual lines, though larger small firms (up to 500 employees) may face planning costs up to $183,838 depending on the high-cost implementation scenario.^[43] For implant manufacturers specifically, process redesign costs can reach $25,000 for small operations under proposed rule estimates. Ongoing recurring costs, such as GUDID recordkeeping and incremental labeling materials, total approximately $105.9 million annually across the domestic industry, with small manufacturers bearing a disproportionate share relative to revenue, where 32 small firms (0.6% of total) exceed 1% of revenue impact from direct marking requirements.^[43]^[44] Technical hurdles further complicate UDI adoption, especially for legacy systems and devices with constrained labeling space. Many manufacturers rely on outdated inventory and production systems incompatible with UDI data capture and integration, necessitating costly upgrades or workarounds to handle device identifiers alongside existing legacy codes, as highlighted in IMDRF guidance on foundational UDI adoption.^[13] For small devices, such as certain catheters or implants with diameters under a few millimeters, applying readable UDI labels or direct marks poses physical challenges due to limited surface area, often requiring exceptions or alternative formats like RFID under FDA provisions to avoid compromising device integrity.^[45] Global inconsistencies in UDI standards create additional barriers, as jurisdictions adopt varying requirements despite IMDRF efforts toward harmonization. While core principles like device and production identifiers are aligned in documents such as the IMDRF UDI Application Guide, regional differences in data submission formats, database structures, and compliance timelines—such as the EU's phased EUDAMED rollout versus the US GUDID—result in non-uniform implementation, increasing complexity for multinational manufacturers. As of 2025, the EU's EUDAMED database UDI module is expected to be fully operational by the end of Q2, supporting improved data submission and harmonization.^[33] This lack of full convergence is evident in ongoing IMDRF strategic plans through 2025, which emphasize but have not yet achieved complete regulatory alignment across member countries.^[46] Compliance gaps persist, particularly in low-resource countries where UDI adoption lags due to infrastructural and economic constraints. In regions outside major markets like the US and EU, implementation delays stem from limited access to issuing agencies, database infrastructure, and trained personnel, with countries such as those in parts of Africa and Asia facing extended timelines beyond 2025 for full rollout.^[33] These gaps hinder global traceability, as noted in analyses of regional disparities that underscore the need for capacity-building support to bridge adoption in resource-limited settings.^[47] As of 2025, the FDA does not intend to enforce GUDID submission requirements for most low-risk Class I devices, due to ongoing implementation challenges that strain oversight resources.^[11] Privacy concerns also arise with serial number tracking in UDI production identifiers, as the inclusion of lot, batch, or serial data in public databases like GUDID raises potential risks of unauthorized access to sensitive supply chain information, though FDA safeguards certain elements like listing numbers as confidential to mitigate exposure.^[48]

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[PDF] Amendments to the Pharmaceuticals and Medical Devices Act in ...
Many manufacturers with healthcare business experience in Japan may already be familiar with the PMD Act and current regulatory framework.<|separator|>
[33]
global medical device UDI requirements and timelines - Rimsys
Feb 10, 2025 · This article details the UDI deadlines for the countries which have announced specific programs (draft or implemented) and is current as of the date of this ...
[34]
A surgeon's primer on Unique Device Identifier (UDI) capture
The Unique Device Identifier (UDI) system was developed to improve the identification and tracking of medical devices throughout their lifecycle.
[35]
Contact an FDA-Accredited Issuing Agency
May 16, 2024 · FDA-accredited agencies include GS1 (937-610-4225), HIBCC (602-381-1091 ext. 101), and ICCBBA (909-793-6516). Contact them directly for UDI ...
[36]
ISO/IEC 15459-1:2014 - Unique identification
In stockISO/IEC 15459-1:2014 specifies a unique string of characters for the identification of individual transport units.
[37]
Recognized Consensus Standards: Medical Devices - FDA
Dec 4, 2017 · This part of ISO/IEC 15459 specifies a unique string of characters for the identification of groupings of products, product packages, transport ...
[38]
21 CFR § 830.20 - Requirements for a unique device identifier.
Conform to each of the following international standards: (1) ISO/IEC 15459-2, which is incorporated by reference at § 830.10;. (2) ISO/IEC 15459-4, which is ...<|separator|>
[39]
[PDF] UDI guidance: Unique Device Identification (UDI) of medical devices
Dec 9, 2013 · This document provides UDI guidance for medical devices, clarifying and supplementing previous guidance with non-binding rules for regulation.
[40]
The Origins of UDI | USDM Life Sciences
My 10-year journey to develop and (finally) publish the US Food and Drug Administration (FDA)'s Unique Device Identification (UDI) System regulation.
[41]
[PDF] The promise of global standards in healthcare - GS1
We estimate that the healthcare supply chain could cut data processing costs by 50-70% using global standardization and synchronization, which would save $1-2 ...
[42]
Study: Nearly one-third of device adverse event reports were late or ...
More than 1 million medical device adverse event reports sent to the US Food and Drug Administration@s (FDA) Manufacturer and User Facility Device ...
[43]
[PDF] GS1 Guide on Unique Device Identification (UDI) implementation in ...
The U.S. FDA published its Final Rule on UDI on 24 September 2013. The European. Commission has also developed UDI requirements, that are part of the EU Medical.
[44]
[PDF] ECONOMIC ANALYSIS OF THE FINAL RULE - FDA
The U.S. Food and Drug Administration (FDA) is finalizing a rule requiring unique device identification (UDI) for medical devices to meet ...
[45]
[PDF] Unique Device Identification System; Proposed Rule - FDA
Process redesign costs for implant manufacturers range from $25,000 for small ... Costs of UDI Implementation for All Labelers Under the. Labeling Only ...
[46]
UDI Exceptions and Alternatives - FDA
UDI exceptions/alternatives allow labelers to request exceptions if UDI is not technologically feasible, or if an alternative provides more accurate device ...
[47]
[PDF] IMDRF Strategic Plan 2021 - 2025
Sep 25, 2020 · Promoting harmonized pre-market review requirements will improve transparency and predictability to stakeholders enabling timely access to safe ...
[48]
Third Quarter of 2024: Global Medical Device Regulatory ...
Oct 3, 2024 · This update features regulatory harmonization and a number of global developments revolving around Unique Device Identifiers (UDI).Missing: percentage | Show results with:percentage
[49]
FDA delays UDI database enforcement for low-risk devices
Aug 4, 2022 · However, FDA will maintain its enforcement date for compliance with UDI labeling, date format, and direct-mark requirements for Class I and ...
[50]
UDI Data Security: Why it should be important to you
Nov 14, 2016 · Confidentiality: Not all data you submit to FDA as part of a UDI data record is public. For example, the FDA listing number contained in the ...Missing: enforcement issues concerns