Clinical Data in Support of US FDA 510(k) Submissions

Download white paper - US Clinical Data in Support of US FDA 510(k) Submissions

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Did the FDA request prospective human clinical data for your 510(k) submission? If so, it’s time to read up on regulatory requirements for quality assurance in human clinical studies. Failure to understand these requirements could lead to the FDA rejecting your clinical results, serious compliance actions, and a substantial waste of time and resources.

This white paper provides insight into these requirements and breaks down the key elements of an effective, compliant clinical study. We’ll answer your biggest questions about quality assurance measures for one of the most significant (and expensive) endeavors you can undertake on the road to FDA clearance.

What you will learn in this 5-page white paper:

  • How to develop an outline for the clinical research protocol?
    • How to develop the research question?
    • How to determine the sample size for the study?
    • How to implement clinical data management?
  • How to define statistical evaluation of data and regulatory requirements?
  • What are the quality requirements for clinical studies?
  • How to compile and analyze data?

Get answers to all of these questions and more in this white paper.

About the Author

Robert Seiple, RAC (US): 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.