De Novo Overview & Eligibility
US-unique
The De Novo pathway is a US-specific regulatory route created by the FDA Safety and Innovation Act (FDASIA) 2012 as a standalone pathway. It has no direct equivalent in TGA, CE, Health Canada, or HSA frameworks.
What is De Novo?
The De Novo classification request is a regulatory pathway for novel, low-to-moderate risk devices that have no legally marketed predicate — meaning a traditional 510(k) is not available. A successful De Novo:
- Establishes a new device type (product code) with a corresponding classification (Class I or Class II)
- Establishes special controls for that device type
- Results in a De Novo order that authorises marketing
- Creates a legally marketed reference device that future 510(k) submitters may use as a predicate
When is De Novo used?
De Novo is appropriate when:
- Your device is novel — no valid predicate exists for a 510(k)
- Your device is low-to-moderate risk — not requiring the full PMA standard of valid scientific evidence
- You have received an NSE (Not Substantially Equivalent) determination on a 510(k) and believe the device is not Class III
- You want to establish a new device type with associated special controls
What De Novo produces
A granted De Novo order:
- Classifies the device as Class I or Class II
- Establishes special controls specific to the new device type
- Assigns a new product code
- Is publicly posted on FDA's De Novo database
- Serves as a legally marketed reference for future 510(k) predicates