Live! #12 — Tips and Tricks for a Smooth 510(k) Process


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This is the audio-only version of DEVICE LOVE Live! #12, originally recorded July 2nd, 2020.

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:

  • Content
  • Compilation
  • Format
  • Internal review
  • Communication with FDA
  • Refuse-To-Accept (RTA) issues
  • Fulfilling requests for additional information

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


  • Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at

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