FDA's New UDI Labeling Requirements

Scheduled On : Wednesday, April 9, 2014 at 1 PM EDT | 10 AM PDT

Duration : 90 Minutes

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Description : 

The U.S. FDA has just published their long-anticipated Unique Device Identification System Final Rule, on September 23, 2013. It's purpose is to "establish a system to adequately identify devices through distribution and use."  It requires the development of a unique device identifier (UDI) in plain text and machine readable formats, to be part of the labeling of every medical device. There is an 4+ year phase in depending upon the risk / class of the device. In addition, the four key steps to compliance by device manufacturers will be addressed. The Final Rule also has provisions to address existing FG inventory, not properly labeled.

The FDA intends for the UDI to facilitate improve device visibility through distribution to patient use, to aid in adverse events reporting, resolution and trending, commonality of nomenclature in clinical information systems, registries, electronic health records, and similar.

This is a major change for medical device manufacturers, with far-reaching effects in regulatory compliance, as envisioned by the FDA.  Our instructor, John E. Lincoln has also just completed an article on UDI to be published in an upcoming journal article.

Areas Covered in the Session :

This Final Rule focuses on two core elements, as will this webinar (in-depth)

• The UDI code, consisting of the DI, device identifier, and the PI, production identifiers (UDI = DI + PI), types of acceptable formats, and its use on device labeling
• The FDA-administered Global Unique Device Identification Database (GUDID)

Who Will Benefit: 

This webinar will provide valuable information to all regulated medical device companies that are or anticipate selling devices in the U.S. Its principles apply to Personnel / Companies primarily in the Medical Devices fields. The employees who will benefit include:

• Senior management
• Middle management
• R&D
• Engineering
• Software
• QA / RA
• Manufacturing
• Operators
• Consultants
• CGMP instructors
• Device Design Team
• Device Development Team
• Device Manufacturing Team
• Verification and/or Validation planning, execution and documentation for devices.

Speaker Profile

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.