Kosta Makrodimitris
Instructor Kosta Makrodimitris
Product Id 600999
Duration 90 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Unique Device Identification (UDI): Upcoming FDA Rules, Requirements and Timelines for Industry and Hospitals


US-FDA has released a proposed rule (2012) that most medical devices distributed in the United States carry a unique device identifier (UDI). Congress passed legislation in 2007(FDAAA) directing the FDA to develop regulations establishing a UDI system for medical devices.

A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help to identify product problems more quickly, better target recalls and improve patient safety.
A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date.

The UDI is expected to improve patient safety

  • by helping to identify counterfeit products a
  • by improving the ability distinguish between devices
  • improving the recall process,
  • creating efficiencies within the medical system

Areas Covered in the Session:
  • 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:
  • Medical Compliance Officers
  • 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

Speaker Profile
Kosta Makrodimitris, PhD, CF-FDA, CP-EHR, is Biomedical/Health Informatics Advisor, Author & Strategist.

Dr. Makrodimitris is the principal for K Makrodimitris that specializes in Health IT & BIO business development, eHealth education, Health Information policy.

He is certified on EHR/PHR, Clinical Trials, Biotech/Drug Development, and trained in US FDA/DHHS laws, regulations (devices, foods, drugs, personalized health). He is involved as, Medical Devices Committee Member, Writer at The Food and Drug Law Institute, Consultant (Health Informatics/Policies/Standards) at DHHS/ONC, Standards & Interoperability Health Information Management Systems Society, Health Level 7(EHR, Genomics, mHealth) , small businesses, Nifty-Fifty Nominee nationwide, Speaker, Volunteer at USA Science Festival

His multifaceted area of work is in health technology, architecture, policy and decision making.

In academia (Johns Hopkins, University of Virginia), Kosta researched and published articles in archival journals concerning biomedical and chemical informatics, In industry (FannieMae, Sysco, MAKROnanoKosmos), Kosta designed systems, managed analytics projects, cofounded eHealth business contributing to solutions (foods, health, finance).

In government (US-FDA/DHHS Commissioner's Fellow), he worked in regulatory science, enterprise architecture, standards & policy in public health. In MD State he was program manager for BIO-economic development.

Sign Up for Our Newsletter