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 to be Covered:
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:
QA / RA
Device Design Team
Device Development Team
Device Manufacturing Team
Verification and/or Validation planning, execution and documentation for devices