“Start Now,” was the advice that Jay Crowley, Senior Advisor, FDA, provided the audience during Clarkston’s What’s Next for UDI webinar on December 5, 2012.
As discussed in the webinar, the estimated mid-May 2014 date for Class III devices may seem like plenty of time to prepare. However, we should consider not only the level of effort, but also the number of functional areas that will be involved in making this happen. The strategy and plan will help identify products affected, roles and responsibilities, training needs, processes for redesign, marketing impacts and end users requiring education. We also need to consider change control, equipment impacts, process control, supplier management, production planning, verification and validation. Last, we would be remiss not mentioning the SOPs that will need to be changed.
And, the ramifications of not being prepared? Companies cannot deliver product, which should be enough to propel us into action today.
If your company is well on your way to implementation, congratulations for getting ahead of the curve. If you plan to execute with internal resources, consider asking a knowledgeable outside partner to help with success checks along the way. These will ensure you are meeting both your internal expectations, as well as complying with regulations.
If you haven’t started yet, now is the time. Consider whether you will design and execute the project with internal or external resources. If you are considering external resources, now is certainly the time to choose your partner and get started.