The De Novo Pathway: When to Use It and How It Works

The De Novo pathway was created in 1997 and significantly expanded by the 21st Century Cures Act in 2016. It provides a route to market for novel, low-to-moderate risk devices that have no valid predicate — devices that would otherwise be automatically classified as Class III simply because they don't fit an existing category.

Understanding De Novo matters even if you're pursuing a 510(k): the cleared De Novo devices that exist today are often the best predicates for follow-on 510(k)s in emerging device categories. And if your device is genuinely novel, De Novo may be your only realistic path to Class II classification.

What De Novo actually does

A De Novo request asks FDA to create a new device classification. When FDA grants a De Novo, it:

• Assigns your device to Class I or Class II (not Class III)
• Creates a new product code specific to your device type
• Establishes special controls appropriate for that device type
• Makes your cleared device a legally valid predicate for future 510(k)s in the same category

When De Novo is appropriate

1. Your device is novel — no legally marketed device with the same intended use and technological characteristics exists
2. The device presents low to moderate risk
3. General controls alone, or general and special controls together, are sufficient to provide reasonable assurance of safety and effectiveness

De Novo is not appropriate as a workaround when a valid predicate exists but the substantial equivalence argument is difficult. Before committing to De Novo, search thoroughly across all product codes — regulatory consultants regularly find valid predicates under codes that weren't the first candidate.

The two routes to De Novo

Direct De Novo — submit a De Novo request directly without first filing a 510(k). Faster if you're confident no predicate exists.

Post-NSE De Novo — file a 510(k), receive a Not Substantially Equivalent determination, then submit a De Novo request within 30 days. This path confirms through FDA's own review that no predicate exists — which strengthens the De Novo rationale.

What a De Novo request must contain

• Classification proposal — your proposed device class and rationale for why general controls (with or without special controls) are sufficient
• Proposed special controls — a specific, enforceable set of controls for this device type
• Performance data — bench, animal, and clinical data demonstrating safety and effectiveness
• No valid predicate argument — documentation that you've searched the 510(k) database thoroughly

De Novo timeline and FDA fees

FDA's goal for De Novo review is 150 days from acceptance. In practice, total time typically runs 12-24 months. De Novo user fees are significantly higher than 510(k) fees — over $500,000 for large companies in 2026, with reductions for small businesses and potential waivers for first-time applicants.

De Novo clearances as 510(k) predicates

This is where De Novo is directly relevant to Predicase users: once a De Novo is granted, the cleared device becomes a legally valid predicate. Many emerging device categories — AI diagnostics, wearable monitors, digital therapeutics — have their first regulatory anchor in a De Novo clearance. If you're filing a 510(k) in one of these categories, the cleared De Novo device is likely your best predicate.

Search for De Novo-originated clearances in your product code by looking for K-numbers associated with devices that were themselves cleared via De Novo, or by checking the clearance type field on recent clearances in your category.