Tips and Tricks for a Smooth 510(k) Process
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Whether you're on your first 510(k) submission at a startup or your 50th at a large company, you likely have some anxiety over the unpredictability of the process. Let our submission experts will help ease your mind! The panel includes recent CDRH staff who will discuss their tips and tricks for a smooth 510(k) submission process.
We'll cover best practices in all aspects of 510(k) submissions:
Communication with FDA
Refuse-To-Accept (RTA) issues
Fulfilling requests for additional information
Please bring your questions!
Here's the panel:
Nancy Morrison — Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q
- Kevin Go — Senior Engineer (former FDA CDRH Lead Reviewer)
- Bryan Pinder — Project Engineer (former FDA CDRH Lead Reviewer)
- Michael Wolford —Senior Principal Specialist, R&Q