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FREE ON-DEMAND WEBINAR
10 Steps to Preparing Your 510(k) Submission (And How to Avoid the Common Pitfalls)
This webinar will focus on the key steps when preparing your 510(k) Premarket Notification and some of the common pitfalls that can occur during this process.
A 510(k) submission allows a medical device manufacturer to claim that their device is substantially equivalent to a device that is already commercially available, also known as a predicate device. It includes many components such as the device description, performance testing, and a discussion about substantial equivalence.
Choosing an appropriate predicate device, knowing how to interact with your FDA review team, and deciding what to include (and not include!) in your file are crucial components to ensure the success of your device.
During this free 60-minute webinar hosted by Allison Komiyama, Owner and Principal Consultant of AcKnowledge Regulatory Strategies, LLC, you will learn how to approach a 510(k) Premarket Notification, with considerations for potential predicates, FDA timelines, and how to avoid delaying submission review.
Watch the webinar
Specifically, this webinar will cover:
- 510(k) Premarket Notification process and components
- Timeline for 510(k) submissions
- Requirements for a 510(k) submission
- Common pitfalls that occur and how to avoid them
- Q&A Session
Who Should Attend?
- Medical Device Industry Executives
- Quality Professionals and Management
- Regulatory Professionals and Management
- Clinical Affairs Professionals and Management
- R&D Engineers and Management
