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Strategies for meeting FDA's UDI Rule


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If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule.

UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings.

UL offers a full suite of services to support compliance with FDA's UDI Rule.

For more information, please contact us and request a sell sheet at, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434

Published in: Government & Nonprofit
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Strategies for meeting FDA's UDI Rule

  1. 1. Unique Device Identifier (UDI) Linda Chatwin, Esq. RAC Business Manager Medical Regulatory Advisory Services
  2. 2. AGENDA Background of the rule Regulations affected by the rule Reason for the rule Requirements for the unique device identifier Requirements for the Global Unique Device Identifier Database Timelines and types of devices for compliance Specifics about the rule Question and Answer 2
  3. 3. Background – Report Commissioned by FDA Issued March, 2006 In 2004, the United States Food and Drug Administration (U.S. FDA) promulgated a regulation to require bar code identification on pharmaceutical labeling FDA asked for public comment on whether such a regulation should be extended to medical devices FDA chose not to include medical devices in the bar code rule, noting a lack of standard and unique identifying system comparable to the National Drug Code system Product identification scenarios – 10 types with varying methods to address problems. Benefits of traceability examined 3
  4. 4. Report Conclusion POTENTIAL ROLE FOR GOVERNMENT Thus, the Federal government might be able to generate net social benefits by providing organizing principals for a UDI system. This is a traditional role for government, i.e., organizing socially beneficial efforts that the private sector will not organize itself. Further, as a leading healthcare provider, the Federal government would capture the supply chain savings from implementation of UDI. Prepared by: Eastern Research Group, Inc. 110 Hartwell Avenue Lexington, MA 02421 4
  5. 5. Background - FDA In response to growing calls for the development of a standardized medical device identification system, Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA mandated the U.S. Food and Drug Administration (FDA) to create a unique device identification system that would enable tracking and identification of medical devices across the medical device lifecycle (i.e., from production through use in clinical practice). In response to this mandate, on July 10, 2012, the FDA published its Proposed Rule for a Unique Device Identification System in the Federal Register 5
  6. 6. FDA Pilot Activities On November 30, 2010, FDA published the result of Pilot Activities conducted over the previous 2 years Focused UDI pilot activity gathered information on the business processes for those stakeholders interested in regulation, manufacture and use of medical devices Identified issues and answered questions about populating and using the UDI database to improve the identification of device information and ultimately to improve their safe and effective use Resolved many issues which lead to release of the proposed UDI rule on July 3, 2012 Final rule issued September 24, 2013 on/ucm235962.htm 6
  8. 8. UDI Reasons for Rule The Unique Device Identification (UDI) is a unique number pertaining to a medical device that enables - Traceability of devices more efficiently - Enhances capture of correct information about devices and reduce medical errors - Enhances effective adverse event reporting - Allow easier recall of devices - Fights against counterfeiting - Lead to a global device identification system
  9. 9. Unique Device Identifier System • UDI = Device Identifier (DI) + Production Identifier (PI) Source: FDA website
  10. 10. UDI - Device Identifier (DI) mandatory, fixed portion of a UDI, that identifies - Labeler - Specific version or Model of a Device
  11. 11. UDI – Production Identifier (PI) a conditional, variable portion that identifies - LOT or batch number - Serial number - Expiration date - Date a specific device was manufactured - Distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.
  12. 12. Unique Device Identifier System Both formats: Human readable (alphanumeric) and Automatic Identification and Data Capture (AIDC) in compliance with globally accepted standards - Series of ISO/IEC 15459-2, ISO/IEC 15459-4 and ISO 15459-6: Information technology -- Unique identifiers - ISO/IEC 16022 :2006 Information technology – Automatic identification and data capture techniques – Data Matrix bar code symbology specification; - ISO/IEC 18004:2006 IT AIDC techniques QR Code 2005 bar code symbology specification; - ISO/IEC 15417:2007 IT AIDC techniques – Code 128 bar code symbology specification.
  13. 13. US FDA Final Rule -Compliance Dates for the UDI Compliance Date Requirement 1 year after publication of the final rule (September 24, 2014) Class III device– Labels and packages bear UDI Data submitted to GUDID Class III stand-alone software must provide its UDI 2 years after publication of the final rule (September 24, 2015) The labels and packages of implantable, life-supporting, and life-sustaining, used more than once, reprocessed, stand- alone software devices must bear a UDI. (Permanent if reused) Data submitted to GUDID 3 years after publication of the final rule (September 24, 2016) Class II device– Labels and packages bear UDI Class III permanently marked Data submitted to GUDID Class II stand-alone software must provide its UDI 5 years after publication of the final rule (September 24, 2018) Class I device– Labels and packages bear UDI Class II reprocessed permanently marked Data submitted to GUDID Class I stand-alone software must provide its UDI 7 years after publication of the final rule (September 24, 2020) All Device – (Class I devices, and devices that have not been classified into class I, class II, or class III) that are required to be labeled with a UDI, must a bear UDI Source:
  14. 14. US FDA - Final Rule Source: - Class I Devices do not need to include Production Identifier (PI) - UDI Exemption: Individual Single-Use Devices, distributed in the same device package and not intended for individual distribution - UDI Exemption:GMP-exempt class I devices as defined in 21 CFR Parts 862-892 (Code of Federal Regulations)
  15. 15. GUDID (Global Unique Device Identification Database) Part of the UDI system, will include a standard set of basic identifying elements Most information will be made available to the public so that users of a medical device can easily look up information about the device The FDA has issued draft guidance is designed to help labelers prepare to submit information to the GUDID Describes key GUDID concepts such as accounts, user roles, the device identifier record life cycle, package configurations, data attributes
  16. 16. Guidance – Global UDI Database (GUDID) - Global Unique Device Identification Database (GUDID) (draft guidance, dated September 24, 2013) - Appendix B: GUDID Data Elements Reference Table (May 7, 2014) - Appendix C: UDI Formats by FDA-Accredited Issuing Agency (May 7, 2014) - GUDID User Manual (Version 1, dated May 2014) UDI will be built by one of the accredited standard organizations according to ISO 15459 (GS1; HIBCC; ICCBBA). Manufacturer chooses to work with one or more of these issuing agencies. DID/ucm20038750.htm#guidance
  17. 17. Exceptions General exceptions from the requirement for the label of a device to bear a unique device identifier (§ 801.30) The UDI rule provides exceptions from the requirements of § 801.20 for certain categories of devices. A labeler of a device identified in § 801.30 is not required to request an exception from FDA. Request for an exception from or alternative to a UDI requirement (§ 801.55) A labeler may submit a request for an exception from or alternative to the requirement for the label of a device to bear a unique device identifier (§ 801.204) or other UDI requirement under 21 CFR 801 Subpart B (Labeling Requirements for Unique Device Identification) for a specified device or a specified type of device Time extension for a class III medical device or a device licensed under the Public Health Service Act A labeler may submit a request for a 1-year extension of the compliance dates for a class III medical device or a device licensed under the Public Health Service Act. Such a request must be submitted no later than June 23, 2014. eptionsAlternativesandTimeExtensions/default.htm?source=govdelivery&utm_medium=email&utm _source=govdelivery
  18. 18. Europe Recommendation issued April, 2013 Reason: Current regulation does not include specific provisions on traceability, which is essential in patient safety by facilitating vigilance, market surveillance and transparency. Action: EU commission recommends member states to integrate unique device identification (UDI) system which is compatible in each member state. Expectation: Avoid the risk of incompatible and divergent systems frustrating the objectives of the internal market. Source:
  19. 19. Europe - UDI - Effective with the upcoming EU Medical Device Regulation - Covering medical devices, active implantable medical devices and in vitro diagnostic (IVD) devices - Fed into the EUDAMED database
  20. 20. IMDRF UDI Guidance Dec. 2013 Source: IMDRF
  21. 21. Examples – UDI GS1
  22. 22. Examples – UDI - HIBCC
  23. 23. Examples – UDI ICCBBA
  24. 24. THANK YOU. Questions? Linda Chatwin, Esq, RAC UL Medical Regulatory Advisory Services T: 1-360-815-5556 E: or W: or