At the Medical Device and Manufacturing (MD&M) East Conference last Tuesday, I had the pleasure of speaking about the new technology solutions that Ross PPD is offering for electronic instructions for use (eIFU) and unique device identification (UDI). I, as well as multiple other industry thought leaders, had the opportunity to present my views on the forthcoming FDA regulations mandating UDI compliance.
The consensus among all of the speakers was that the deadline for the final rule, which happened to be the next day, June 19, would be missed and in fact it was. Other speakers included Judy Bunch of QAConsulting, Jackie Elkins of Medtronic, Jeffrey Secunda of AdvaMed, Dennis Black of BD, John Roberts of GS1 Healthcare US, and Philip Lamory of Clarkston Consulting. They alternatively explained what to expect from UDI regulations and how to address compliance.
The primary reason for UDI from an FDA perspective was identified as improved post-market surveillance. Various other benefits were discussed as well. While the FDA’s goal of improved post-market surveillance is clear, Ross PPD has another perspective how to best embrace UDI compliance and integrate it with eIFU. To us, UDI is about improved communication, which is also one component of eIFU. Our approach assigns unique URLs (unique websites) to each individual medical device and is aimed at ultimately optimizing end user accessibility and understandability.
The consensus among all of the speakers was that the deadline for the final rule, which happened to be the next day, June 19, would be missed and in fact it was. Other speakers included Judy Bunch of QAConsulting, Jackie Elkins of Medtronic, Jeffrey Secunda of AdvaMed, Dennis Black of BD, John Roberts of GS1 Healthcare US, and Philip Lamory of Clarkston Consulting. They alternatively explained what to expect from UDI regulations and how to address compliance.
The primary reason for UDI from an FDA perspective was identified as improved post-market surveillance. Various other benefits were discussed as well. While the FDA’s goal of improved post-market surveillance is clear, Ross PPD has another perspective how to best embrace UDI compliance and integrate it with eIFU. To us, UDI is about improved communication, which is also one component of eIFU. Our approach assigns unique URLs (unique websites) to each individual medical device and is aimed at ultimately optimizing end user accessibility and understandability.
For more information about Ross’ approach or to request a whitepaper please visit www.mddtrack.com. For more information on the MD&M East 2013 conference, visit www.mdmeast.com.
