Proxima & Medrio partnered on a guide on how to navigate FDA De Novo Clinical Trials.
Proxima & Medrio partnered on a guide on how to navigate FDA De Novo Clinical Trials.
Contributing experts: Ellie Reynolds, Director of Regulatory Affairs & Quality Assurance at Proxima CRO, and Tina Caruana, Director of eClinical Solutions at Medrio
Some sponsors choose the FDA De Novo pathway to bring new, low-to-moderate-risk medical devices to market. Often, De Novo submissions require clinical data, and these trials come with different rules, risks, and opportunities than 510(k) or Premarket Approval (PMA) routes.
This guide breaks down the FDA’s De Novo pathway so you can move forward with clarity and confidence.
In this blog post, you’ll learn:
- What qualifies as a De Novo clinical trial?
- How does De Novo differ from 510(k) and PMA?
- What are common misconceptions about De Novo?
- What are the advantages of De Novo classification?
- How can you design a De Novo study for FDA clearance?
- What technology should you consider?
- What technology vendor attributes are important to look for?
.png)
