Please join Hogan Lovells' Medical Device lawyers Danielle Humphrey and Kristin Zielinski Duggan for a complimentary webinar discussing the impact of FDA's new draft guidance documents on the regulatory decision-making process for modifications to 510(k) cleared devices.
Topics covered during this webinar will include:
- Overview of FDA's New Draft Guidance Documents: Deciding When to Submit a 510(k) for a Change to an Existing Device and Deciding When to Submit a 510(k) for a Software Change to an Existing Device
- What’s Changed since FDA's 1997 Guidance (K97-1)?
- Has FDA Addressed Industry's Concerns Regarding the Withdrawn 2011 Guidance?
- Will More 510(k)s be Required?
- Regulatory Standard and Guiding Principles for Assessments of Device Modifications
- Assessing Software Changes: Which Guidance Applies?
- Key Considerations for Labeling Changes; Technology, Engineering, and Performance Changes; Material Changes; and Software Changes
- Using FDA's New Flowcharts
- Risk Assessments for Modified Devices
- How to Handle Manufacturing Changes
- Documentation of "No-File" Decisions