Freyr UDI Services


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On September 24, 2013, the U.S. Food and Drug Administration announced the new requirement to identify medical devices that affect its safe and effective use through the use of UDI. Explore on how Freyr can help medical device companies achieve UDI compliance.

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Freyr UDI Services

  1. 1. Global Regulatory Solutions & Services FDA Unique Device Identification Mandate for Medical Devices The FDA UDI Regulation will enact a single device identification system that is uniform, univocal, standardized, and globally coordinated. All Medical Device companies will be required to comply with the new UDI approach. While manufacturers stick to the UDI regulations, they will also have to exploit on the advantages of streamlining procedures through uniquely identifying and improving patient safety, attributions and procedures. ISSUING AGENCIES FDA recognizes three agencies (GS1, HIBCC and ICCBBA). Manufactures have to obtain the UDI from one of these agencies. Also Labelers have option to choose the type of AIDC (Automatic identification and data capture) technology. Agencies accept ISO 15459 series of standards. The European Commission (EC) has announced the release of its recommendation on a framework for a unique device identification (UDI) system for medical devices marketed in the European Union1 FDA – UDI Mandate On September 24, 2013, the Food and Drug Administration (FDA) issued the Unique Device Identification (UDI) System Final Rule2, which establishes a system for adequately tracking and identifying medical device adverse events and safety issues through distribution and use within United States. Medical devices that are presumed critical are subject to this mandate, starting with the most critical (Class III) and ending with least critical (Class I) devices. 1 See European Commission, common framework for UDI for medical devices for more information 2 See U.S. Food and Drug Administration (FDA), Unique Device Identification (UDI) final rule at Federal Register for more information. CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | CONSULTING
  2. 2. Global Regulatory Solutions & Services What is UDI ? The UDI is a unique combination of numeric or alphanumeric codes —in both a human-readable form and a machine-readable form, that includes a device identifier (DI) which is specific to a device model, and production identifier (PI), which includes the current production information for that particular device, such as the lot or batch number, the serial number, expiration date, device make and model, etc. A unique UDI must be applied to the “base package” and higher levels of packaging. Product data for all medical devices must be submitted and kept up to date in an FDA-managed Global Unique Device Identification Database (GUDID). Benefits of UDI  Increase in patient safety through reporting of adverse events, hereby reducing medical errors.  Imparting a standardized identifier that will assist manufacturers, distributors and health authorities to manage device recalls more efficiently.  Improvising Post-Market Surveillance system for continued safety and effectiveness.  Increase in efficiency of Supply Chain process through proper addressing of fraudulent medical devices.  Implementation of a centralized repository of medical devices, accessible to consumers leading to a globally recognized medical device identification system. UDI Implementation Timelines? The implementation timelines for UDI are based on the level of risk the medical device has, starting from Class III to Class I. However, many low-risk medical devices will be exempt from some or all of the requirements of the Final Rule3. 3 See U.S. Food and Drug Administration (FDA), Unique Device Identification (UDI) final rule at Federal Register for more information. CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | CONSULTING
  3. 3. Global Regulatory Solutions & Services Are you Ready for the Challenge ? Enforcing UDI for medical devices is not an ordinary challenge. Now that the mandate has been passed, medical device manufacturers have to meet the final UDI guideline and ensure the following activities are carried out effectively: Collection, Conversion and Submission of UDI data to GUDID.  Timely review and approval of all UDI data through auditing internal processes.  Create new submissions for all product versions and variants.  Update submissions for changed products.  Track FDA responses, including approvals, rejections, product recalls, etc.  Developing recordkeeping and reporting policies and procedures.  Comply with similar global UDI regulations coming soon from various regional markets. Freyr Roadmap to UDI Compliance Keeping the timelines in mind, Freyr’s roadmap to help medical device companies to UDI Compliance consists of a 3-Step Process. This process signifies Freyr’s dedication to assist and support medical device companies to attain industry compliance. UDI READINESS ASSESSMENT UDI Awareness GAP Analysis Recommendations Integrate Project Planning DATA MANAGEMENT DATA SUBMISSION UDI Data Conversion Gateway setup HL7 SPL Compliance CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | CONSULTING Submission to GUDID Life Cycle Management
  4. 4. Global Regulatory Solutions & Services Freyr Leverage  2 - 4 Week UDI Readiness Assessment  Complete GAP Analysis to meet project’s objectives  Developing an effective roadmap for UDI implementation  Adept Data Management (collection, collation, validation and conversion)  Preparation and UDI Submission Status Reports  Support for current and future submissions with 360° lifecycle maintenance  Centralized repository for audit requests and regulatory submissions  Creating validated HL7 SPL Submission Packages, 21 CFR Part 11 compliant If perfectly brought into play, the UDI data generated will be useful in analytics and research studies across various industries, academics, and health authorities, providing a better understanding of device use and achieved patient outcomes. Freyr Facts Freyr is a Progressive, Fast-growing, Global Regulatory Solutions & Services company, focusing exclusively on the entire Regulatory value-chain of Life Sciences companies. Headquartered in New Jersey, USA with Regulatory Operations and Data Centre in Cranbury, NJ, USA. Global Regulatory Operations & Development Centre in Hyderabad, India, Asia's leading BioTech Hub. Rapidly growing strong 200+ team of regulatory, scientific, technology and consulting workforce. Multi-year, successful engagements with Top 10, Fortune 50 Pharma/Consumer and SmallMedium Life Sciences companies providing bestin-class Regulatory Consulting, Technology and high-value/low-cost Offshore Outsourcing Services Management team with a rich background and global experience in regulatory, life sciences, business operations, and information technology, driving global vision and innovation All systems and processes are 21 CFR Part 11 Compliant. Quality Management System – ISO 9001 certified. State-of-the-art Infrastructure with ISO 27001 certified information security management, and robust BCP & DR site. Management focus to embrace and seriously contribute to going Green in Social Responsibility initiatives; well integrated and part of company's DNA. CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | CONSULTING
  5. 5. Global Regulatory Solutions & Services US 103 Carnegie Centre, Suite 300, Princeton, NJ – 08540 North America Operations Center 1 Farr View Dr, STE 5E , Cranbury Township, NJ 08512 Phone +1 908 345 5984 Fax +1 866 486 6883 UK 1 Bell Street, Maidenhead, Berkshire, SL6 1BU Phone +44 1133 508632 India Global Operations Center Lanco Hills Technology Park, Manikonda, Hyderabad, India Phone +91 40 4848 0999 Email Copyrights © 2013 Freyr Inc. All Rights Reserved.