Preparing a US FDA Medical Device 510(k) Submission

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Are you ready to sell your medical devices in the United States? Before you enter the US market, you need clearance from the US Food and Drug Administration, which means you probably need to submit a 510(k).

510(k) submissions, also known as Pre-Market Notifications, are required by the FDA for a range of medical device types and classifications. 510(k)s have unique content and format requirements – they are not identical to a European Technical File. And, the FDA's recent changes to 510(k) requirements make the submission process more rigid than ever. In this white paper, we will address your biggest questions about submitting a 510(k) in today’s market. What you will learn in this 10-page white paper:

  • What kinds of devices require a 510(k)?
  • How do I classify my device per the FDA predicate system?
  • How long does the 510(k) review process take?
  • What mistakes can slow or even stop the review process?
  • What happens if I get a Refuse-to-Accept (RTA) or Additional Information Required (AI) letter?
  • The FDA cleared my device – now what?

We answer all of these questions and many more in this whitepaper.

About the Author

Robert Seiple, RAC (US): Robert Seiple is Senior Regulatory Consultant at Emergo. He has over 35 years of experience with quality assurance and regulatory affairs in regulated industries, including medical devices, pharmaceuticals, and clinical research. His areas of expertise include 510(k) submissions, CE Marking, quality system implementation, training, and auditing.