FDA’s New Guidance’s Deciding When to Submit a 510(k) for Device and Software Changes 2018
21 Sep 2018
Webinar
Description
Topics
Key elements of the U.S. FDA’s new Guidance on Deciding When to Submit a 510(k) for a Software Change to an Existing Device
Key elements of U.S. FDA’s new Guidance on Deciding When to Submit a 510(k) for a Change to an Existing Device
How might these guidance documents affect current device change decisions and 510(k) submissions
Impact on now replaced U.S. FDA 510(k) Memorandum K97-1 on Deciding When to Submit a 510(k) for a Change to an Existing Device
What approaches can companies use at present, and the Agency’s expectations
Who should Attend
Quality Departments
Research and Development Departments
Manufacturing Departments
Regulatory Affairs Departments
Software Engineers
Engineering Departments
All others tasked with device change analysis and device submissions to the U.S. FDA
Senior management in Devices and Combination products
Past Events
FDA’s New Guidance’s Deciding When to Submit a 510(k) for Device and Software Changes 2018 - 21 Sep 2018, Webinar (78347)
Important
Please, check "FDA’s New Guidance’s Deciding When to Submit a 510(k) for Device and Software Changes" official website for possible changes, before making any traveling arrangements
