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An Expert Guide to FDA 510(k) Submissions

Best Practices for Successfully Navigating the Premarket Notification Process

Ever struggle with the complexities of the 510(k) submission process? Want to avoid costly and time-consuming mistakes in your premarket notification? This white paper provides clear, expert-informed guidance on 510(k) submissions.

In it, we cover:

  • The often-overlooked aspects of the 510(k) process
  • Demonstrating substantial equivalence effectively
  • Providing sufficient documentation to the FDA
  • Proactively addressing FDA questions and concerns
  • Writing clear and concise content for FDA reviewers
  • Understanding the review timeline

About the Contributor

Trey Thorsen, MS, RAC

Trey-modifiedTrey is an experienced regulatory affairs consultant who has helped numerous startups and mid-size medical device companies clear their Class I, II, and III devices for the U.S. market.

Download the white paper and get his personal 510(k) playbook.👇

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