Mastering your 510(k) submission process (On-Demand)

1.0 RAC Credits Member: $0 | Nonmember: $25
Mastering your 510(k) submission process (On-Demand)

This is an On-Demand webcast from November 2022.

Bringing a Class II medical device to the American market? You’ll need to go through the 510(k) process, your gateway to FDA clearance. Yet many businesses are getting it wrong: successful applications are falling, and 30% of 2021 applications weren’t even accepted for initial review.

A robust 510(k) plan is crucial for a smooth and speedy route to market. This webinar gives you everything you need to know to become a 510(k) master.

Learning Objectives

  • Understand the optimal pathway to follow for right-first-time, stress-free 510(k) clearance.
  • Learn the most common mistakes the FDA sees in applications, and how to avoid them.
  • Unpick the key ingredients of a 510(k) submission, from predicate devices and substantial equivalence to typical timelines.

Who Should Attend?

Regulatory Affairs Professionals


Kyle Rose

Kyle Rose, Rock Quality Systems


Contact the RAPS Support Center: 

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

Add to Cart

Discover more of what matters to you

Audit/FDA Inspection Biotechnology Combination Products Compliance Medical Devices North America Pharmaceuticals Research, Design and Development

News »