On September 23, 2013, the much anticipated Unique Device Identification System Final Rule was published by the U.S. FDA. It aims to “establish a system to adequately identify devices through distribution and use.” The UDI final rule requires a unique device identifier to be developed in machine readable format and plain text, which is to be a 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 Final Rule will address the four key steps to compliance by device manufacturers and also has provisions to address existing FG inventory, which are not properly labeled.
The Final Rule brings in considerably big changes for medical device manufacturers with far-reaching effects in regulatory compliance, as envisioned by the FDA. It focuses on two core elements and this webinar by expert speaker John E. Lincoln will discuss these two core elements as well as review the implementation schedule of the final rule. John, who has also published an article on UDI/GUDID for an international validation journal, will provide you an in-depth understanding of the Final Rule and what it means for medical device manufacturers.
Who should attend?
- Casper E. Uldriks
John E. Lincoln is the Principal of J. E. Lincoln and Associates LLC, a consulting company; with over 35 years of experience in U.S. FDA-regulated industries, 21 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation...
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