Unique Device Identification (UDI): Upcoming FDA Rules, Requirements And Timelines For Industry

Event Information
Product Format
Prerecorded Event
Presenter(s)
Dr. Kosta Makrodimitris, PhD, CF-FDA, CP-EHR
Length
60 Minutes
Product Description

Are You Ready To Meet The Upcoming UDI Requirements And Rules? Discover the Finer Points of FDA Rules with Dr. Kosta Makrodimitris

The UDI System will assign a unique identifier to medical devices and it was signed into law in 2007, as part of the Food and Drug Administration Amendments Act. FDA proposed rules in 2012 and they plan to release final regulations in 2013.

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).

In this informative session, our expert speaker Dr. Kosta Makrodimitris, PhD, CF-FDA, CP-HER, will explain the current scenario (Food and Drug Administration Amendments Act of 2007, proposed rules and amendments in 2012), provide update on upcoming UDI rules, and discuss about what industry and hospitals should know to conform to UDI rules. He’ll 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. Moreover, our speaker will update you about the relevant UDI and standards in the US and will present the proposed regulations and cases in the field.

In this 60 minute audio conference, he’ll 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, Kosta will also expand on similar UDI initiatives and effort at EU and globally, and the role of Global Harmonization Task Force (International Medical Device Regulators Forum currently).

Here are the tools you will walk away with:

  • Reference documents
  • Policies and Guidances
  • UDI timeline

Session Highlights:

  • Overview and timeline of UDI
  • Proposed UDI regulation(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
  • International Medical Device Regulators Forum
  • Future Of Medical Devices pre- and post- market lifecycle

Who should attend? Manufacturers of Medical Devices (Industry), User Facilities of Medical, Devices(Hospitals, Clinics), Importers, Customs & Border professionals, Medical Device distributors, Medical Compliance Officers, Policy Analysts, Health Information Managers, Legal Counsel,Regulatory affairs, Data and Device Standards experts, Health care distributors, 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

 

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1-866-458-2965

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About Our Speaker

Dr. Kosta Makrodimitris

Dr. Kosta Makrodimitris, PhD, CF-FDA, CP-EHR, 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...   More Info
    More Events By The Speaker

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