FREE ON DEMAND WEBINAR

What's So Special About The “Special” 510(k)?

Why are fewer s510(k)’s being submitted today?

What is the second most used type of 510(k) in medical device submissions to FDA?  There are multiple types of 510(k)’s, but most people are only familiar with the traditional 510(k) (t510k) which is the most used (~75%).  However, if you are not familiar with all types of 510(k)’s, how can you decide which to use and when, i.e., how can you do your job? 

The “special” 510(k) (s510(k)) is the second most commonly used type of 510(k) (~20%) yet many are not familiar with the s510(k).  Why? Either because they never heard of it OR they’ve chosen to do a Letter-to-File (L2F) instead.  In fact, FDA received 436 s510(k) applications (FY2024), down almost 20% from 525 (FY2023), out of 3241 total 510(k) submissions – why?

This webinar will take a critical approach to the Special 510(k) including:

• What is a special 510(k) and when should it be used?
• Why is a special 510(k) “special?”
• Why are fewer s510(k)’s being submitted today?
• How does the s510(k) compare to other types of 510(k)’s and the L2F?
• What are the criteria for a special 510(k)
• What goes into a special 510(k)?  Do you need a predicate?
• How long does a s510(k) really take and what does it cost?
• What’s “new and exciting” in s510(k)’s and what does the future hold?
  

In this webinar, participants will learn best practices to avoid timely and costly mistakes and creative ways to use special 510(k)’s to their advantage!