FDA 510(k) Glossary · pathway

De Novo Classification

De Novo classification is the FDA pathway for novel low-to-moderate risk medical devices with no valid predicate device. A successful De Novo grants Class I or Class II authorization and establishes a new device category - which can then serve as a predicate for future 510(k) submissions by other manufacturers.
Dataset Insight - 510k Database (166,200 records, 1980–2025)
De Novo authorizations are separate from 510(k) clearances. Cleared De Novo devices appear as predicates in 510(k) submissions in the dataset.

Definition

The De Novo Classification Request pathway was established by the FDA Modernization Act of 1997 and significantly revised by FDASIA in 2012. It provides a route to market for novel medical devices that are low to moderate risk but lack a valid predicate device. Without De Novo, such devices default to Class III - requiring the far more demanding Premarket Approval (PMA) process.

How De Novo Differs from 510(k)

Feature510(k)De Novo
Predicate requiredYesNo
Device noveltyMust be similar to predicateNovel or first-of-kind
OutcomeClearanceClassification + Authorization
Can serve as future predicateYesYes
Typical review time~129 days (cleared)150-300+ days
New special controls establishedNoYes - by FDA

The De Novo Process

  1. The manufacturer submits a De Novo Classification Request with evidence that the device is low to moderate risk.
  2. The FDA evaluates whether general controls (Class I) or general and special controls (Class II) provide reasonable assurance of safety and effectiveness.
  3. If granted, the FDA issues an authorization order and establishes a new product code and classification regulation.
  4. The De Novo-classified device becomes a valid predicate for future 510(k) submissions in the new category.

Strategic Importance

A successful De Novo not only grants market access but establishes a new regulatory category - giving the originating manufacturer a first-mover advantage. Competitors seeking clearance for similar devices must file 510(k) submissions citing the De Novo as their predicate. The Radiology panel has seen notable De Novo activity for AI imaging software, particularly under product code QIH.

FDA References

Related Terms

Predicate Device - Substantial Equivalence - 510(k) Premarket Notification - PCCP

Frequently Asked Questions

De Novo classification is an FDA pathway for novel medical devices that are low to moderate risk but lack a valid predicate device for a 510(k) submission. Without De Novo, such devices would automatically default to Class III and require Premarket Approval (PMA). De Novo was established in 1997 and significantly revised in 2012.

A 510(k) requires an existing predicate device; De Novo does not. De Novo results in a new device classification with specific special controls established by the FDA, while 510(k) clearance relies on existing classification regulations. De Novo typically takes longer to obtain and requires more comprehensive evidence.

Yes. This is one of the most strategically important aspects of De Novo. A device granted De Novo authorization becomes a valid predicate for future 510(k) submissions, giving the originating manufacturer first-mover advantage as competitors seek clearance in the same device category.

De Novo is appropriate when no valid predicate exists and the device is low to moderate risk. It is commonly used for novel AI/ML devices, first-in-class diagnostics, and innovative digital health tools. Manufacturers should request a Pre-Submission meeting with the FDA to confirm De Novo is the appropriate pathway before filing.