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:
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
- Dr. David Lim
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: