FAQs
FDA Submission and Regulatory Pathway

Q2: What is the difference between a 510(k) and De Novo submission for an IVD?

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A 510(k) submission is the most common FDA pathway for IVD market authorization. This requires proof that the new device is substantially equivalent to a product already legally cleared for the market. This pre-existing device is known as the predicate device. It must have similar intended use and technological characteristics. If analytical and clinical performance data support an equivalence claim relative to a legally marketed, valid predicate device, the FDA typically clears a 510(k) without requiring formal clinical trials.

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The De Novo pathway applies to novel, low- to moderate-risk devices when no predicate exists. This means there is currently no device on the market with the same intended use and technology. De Novo submissions must establish a new device classification as a novel IVD. The FDA will evaluate whether this new device is safe and effective for its intended use based on general controls and special controls. If it is approved, it creates a new regulatory classification that can serve as a predicate for future 510 (k) submissions. De Novo requires a more significant body of clinical and analytical evidence than a typical 510 (k), and this, in turn, leads to a longer duration for review and completion. 

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Determining whether to pursue a 510(k) or De Novo approval is a key decision milestone that influences the entire course of IVD development. That’s why it is essential to get expert regulatory input early on, prior to formulating analytical and clinical study designs.

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The Landrich Group assisted clients with clearance for meningitis and encephalitis rapid tests by managing usability, analytical, and clinical studies, and preparing a 510(k) pre-market submission.  The Landrich Group is highly experienced in interacting with the FDA on pre-submission, 510(k), De Novo 510(k), and Breakthrough Device Designation regulatory submissions.