FDA s New Guidance s Deciding When to Submit a 510(k) for Device and Software Changes 2018 is a webinar that covers topics such as:
- 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
FDA s New Guidance s Deciding When to Submit a 510(k) for Device and Software Changes 2018 is intended for:
- 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
