We use cookies to deliver our online services. Details of the cookies we use and instructions on how to disable them are set out in our Cookies Policy. By using this website you agree to our use of cookies. To close this message click close.

Modifications to 510(k) Cleared Devices: Assessing the Impact of FDA's New Draft Guidance

16 September 201611:00 AM (EST)

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lawyers Danielle Humphrey and Kristin Zielinski Duggan for a complimentary webinar discussing the impact of FDA's new draft guidance documents on the regulatory decision-making process for modifications to 510(k) cleared devices.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  • Overview of FDA's New Draft Guidance Documents: Deciding When to Submit a 510(k) for a Change to an Existing Device and Deciding When to Submit a 510(k) for a Software Change to an Existing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  • Has FDA Addressed Industry's Concerns Regarding the Withdrawn 2011 Guidance?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

From Hogan Lovells

Loading data