Lessons Learned from Class III UDI Implementation
As most are well aware, FDA is establishing a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form. Device labelers must also submit certain information about each device to FDA's Global Unique Device Identification Database (GUDID). The public will be able to search and download information from the GUDID.
The Food and Drug Administration Safety and Innovation Act ("FDASIA") requires all Class II implantable, life-supporting, or life-sustaining devices to bear a UDI within two years of publication of the final rule, which occurred September 24, 2013. As manufacturers prepare for Class II FDASIA implementation, we will discuss lessons learned from the work done by manufacturers of Class III devices to become UDI compliant. And the issues are not what you would expect.........
This Webinar is Free for FMMC and RAPS-Florida Members!
About our Presenter:
Jay Crowley is the Vice President of Unique Device Identification Services and Solutions at USDM Life Sciences.
Jay was most recently Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for FDA’s Unique Device Identification (UDI) system.
At USDM Life Sciences, Jay focuses exclusively on providing business process, technology and compliance solutions for the regulated life science industry.
Jay held a variety of positions over his nearly 27 years at FDA, including work with design control regulations to reduce the chance of human errors with medical devices, patient safety and adverse event reporting. Jay also worked in the Office of the Commissioner of FDA, and the Office of Compliance at FDA.
Webinar Powered by