Unique Device Identification (UDI): Upcoming FDA rules, requirements and timelines for industry

Why Should You Attend:

Medical device industries (manufacturers), hospitals and providers should plan proactively to prepare systems and processes in order to meet the upcoming UDI requirements and rules. It is critical to get informed on all these guidances for different stakeholders in order to understand better the increasing complexity of the device regulatory process (premarket, postmarket).

This webinar will provide the current and expected policies for Unique Device Identification (UDI) in US regulated by FDA. We will explain the current guidances (Food and Drug Administration Amendments Act of 2007, proposed rules and amendments in 2012), update on upcoming UDI rules and discuss what industry and hospitals should know to conform to UDI rules. This course will explain the requirements for all these roles in industry that need conformance to the regulations and the standard process. The FDA (ISO) codes and standards for UDI data and processes will be described in details at this webinar.

We will also explore relevant UDI and standards in US and we will present the proposed regulations and cases in the field. We will analyze a recent report that FDA published on strengthening the medical device post-market surveillance and UDI plans that will affect the industry in the coming years. Finally we will expand on current similar UDI initiatives and effort at EU and globally and the role of Global Harmonization Task Force (International Medical Device Regulators Forum currently).

Areas Covered in the Webinar:

• Overview and timeline of UDI
• Proposed UDI regulation(FDA, 2012)
• Amendment to the UDI Proposed Rule(2012)
• UDI codes and standards
• Proposed dates for UDI regulations in US
• Benefits of UDI (supply chain, healthcare, industry, public health)
• Post-Market Surveillance & Compliance with UDI
• Lawmakers doubt the release of UDI rule by deadline (2013)
• UDI efforts and recommendations in EU and globally
• Global Harmonization Task Force & International Medical Device Regulators Forum
• Future Of Medical Devices pre- and post-market lifecycle.

Who will Benefit:

• Manufacturers of Medical Devices (Industry)
• User Facilities of Medical Devices(Hospitals, Clinics)
• Importers, Customs & Border professionals
• Medical Device distributors
• Medical Compliance Officers
• Health Information Managers
• Legal Counsel, Regulatory affairs
• Data and Device Standards experts
• Health care distributors
• Group purchasing organizations
• Hospitals and health care providers
• Health care industry professionals
• Healthcare & Devices CIO/CFO/CTO
• Audit/Inspection coordinators, internal auditors
• QA / QC managers, executives and personnel
• Health IT / IS managers and personnel
• Entrepreneurs (Devices, Surveillance, Informatics)
• Consultants and Strategists

Instructor Profile:

Dr. Kosta Makrodimitris, PhD, CF-FDA, CP-EHR, HL7 expert is Biomedical/Health Informatics Advisor, Author & Strategist. He is certified on EHR/PHR, Clinical Trials, Biotech/Drug Development, and trained in US FDA/DHHS laws, regulations (medical devices, foods, drugs, personalized medicine, health IT). He is involved as:

• Advisor and participant (ONC/DHHS for Health IT, Standards & Interoperability Framework, Meaningful Use Stages/EHR, Federal Health Architecture, Health Information Exchanges-HIMSS, Health Level 7/ISO TC215 standards).
• Executive director of Global Bio Health Tech Center and senior policy advisor at CAL2CAL group of companies
• Medical Devices Committee Member, Author at The Food and Drug Law Institute

Dr. Makrodimitris combines a multidisciplinary background and accomplishments in Health IT/Informatics, Policy, Standards and Innovation

- In academia (Johns Hopkins, University of Virginia, EU), he researched concerning biomedical applications and bio-chem-informatics.

- In industry (FannieMae, Sysco/Sentrana, MakronanoKosmos, Cal2Cal) Kosta designed innovative decision systems, managed analytics projects, cofounded eHealth business, consulted business development, provided policy analysis.

- In government (US-FDA/DHHS), Dr. Makrodimitris worked in regulatory science, enterprise architecture, standards, and policy in public health and health IT. He also served as Program Manager, for BIOMaryland Center, Business and Economic Development, MD state.

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