FDA and Industry Facilitators


Thank You to Our Sponsors!

A special thank you to these sponsors for their continued support of Xavier Health through the COVID-19 crisis.


Content Covered

  • History of 510(k)s as well as touching on the other approval pathways to put 510(k) into context

  • Risk Management and Design Controls

  • IDE and clinical data for 510(k)

  • Modifications Document

  • Pre-Subs

  • Who to engage across the TPLC to ensure al the studies, data and information are set for filing – how to mobilize an effective process in your company

The vast majority of medical devices on the market in the United States have successfully navigated the FDA 510(k) process. This strong 510(k) review process is critical to FDA’s mission of protecting and advancing public health. Expert facilitators will engage you in discussion during this hands-on, practical workshop, to provide you with firm insight on when the 510(k) process is right for your company, how to effectively support your product development with data, when to engage FDA in your 510(k) strategy, and when to notify FDA of changes to your product.


How Will This Work?

  • Highly interactive, through the use of virtual breakout rooms, chat box Q&A, and live polling technology.

  • Two concentrated sprints to minimize time away from business matters:

    • July 22, 2020, 12:00pm-3:40pm EDT

    • July 23, 2020, 12:00pm–3:40pm EDT

  • Recordings of each session will be available to you for two weeks after the workshop.

  • You will be emailed your log-in/connection details the week before the workshop starts.


Workshop Outcome

This deep-dive workshop on the 510(k) premarket notification process will arm you with:

  1.  Understanding of when the 510(k) pathway is the right process for your product

  2. Risk Management examples and tools you can apply right away to your design control process

  3. Awareness of when you need clinical trial data and how to manage the IDE (Investigation Device Exemption) process

  4. Understanding when and if to engage FDA through the Pre-Sub meeting process – pros, cons and how to effectively prepare

  5. Insight on the intricacies of the FDA Modifications Guidance – “Deciding When to Submit a 510(k) for a Change to an Existing Device”

  6. Successful strategies for optimizing your product success by engaging your cross-functional peers throughout the total product lifecycle.  


Workshop Facilitators