Modifications to 510(k) Cleared Devices: Assessing the Impact of FDA's New Draft Guidance

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lawyers Danielle Humphrey and Kristin Zielinski Duggan for a complimentary webinar discussing the impact of FDA's new draft guidance documents on the regulatory decision-making process for modifications to 510(k) cleared devices.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  • Overview of FDA's New Draft Guidance Documents: Deciding When to Submit a 510(k) for a Change to an Existing Device and Deciding When to Submit a 510(k) for a Software Change to an Existing Device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  • Has FDA Addressed Industry's Concerns Regarding the Withdrawn 2011 Guidance?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

Listen to the webinar

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