FDASIA Series: “Benchmarking New Requirements of the FDA Safety & Innovation Act”
Hear directly from FDA’s Jay Crowley on FDA expectations for implementing the newly approved UDI guidance. Understand what your company needs to be doing today as he details the challenges industry must overcome. Don’t miss this opportunity to make sure your company is prepared!
Why you should attend:
- “UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
- The 2012 law called FDASIA extended FDA’s authorities in ways that toughen the bite of inspections, and demand more company “E-paperwork” to keep up with evolution in device technologies. The Universal Device Identifier, like a car’s VIN permanently displayed in the windshield for police who are seeking a stolen car, keeps tabs on the most recall-risky of medical devices. UDI has great logistical challenges and more than a few alternative ways to accomplish the necessary identification steps.
- You will also gain insight from other webinar participants.
Course Format: Webinar
5:00 PM - 6:30 PM
Cost: Industry: $347, Small Companies: $277.60, Consultants: $173.50, Start-Up/Academic: $69.40, Governement Official: Free