De Novo Request Requirements & Process
Required content
A De Novo request must include:
| Section | Description |
|---|---|
| Device description | Intended use, device description, components, variants |
| Classification proposed | Class I or II with proposed special controls |
| Risk-benefit analysis | Comprehensive risk analysis (ISO 14971) |
| Performance data | Bench testing, biocompatibility, software validation as applicable |
| Proposed special controls | Draft guidance recommendations or performance standards that mitigate identified risks |
| Labelling | Draft label and IFU |
| Clinical data | If non-clinical data insufficient to establish reasonable assurance |
| eSTAR format | All De Novo requests must use the eSTAR De Novo template |
Proposed special controls
A key component of a De Novo request is the submitter's proposed special controls — specific requirements (such as and performance standards, post-market surveillance, patient registries, labelling requirements) that, together with general controls, provide reasonable assurance of safety and effectiveness.
FDA may accept, modify, or reject the proposed special controls. The final special controls become part of the De Novo order and apply to all future devices of that type.
FDA review process
- Acceptance review — 15 business days (same as 510(k))
- Substantive review — FDA evaluates risk-benefit profile and proposed special controls
- Interactive review / AI requests — FDA may request additional information
- Decision — Grant or decline; MDUFA VI goal is 150 calendar days
After a De Novo grant
- FDA publishes the De Novo order and associated special controls
- A new product code is established
- The granted De Novo device is listed in the De Novo database
- Future manufacturers may use the De Novo device as a 510(k) predicate
Official resources
De Novo Classification Decision
Upon review, FDA will:
• Grant the De Novo request — the device receives authorization to market and is classified as Class I or II with associated special controls • Decline the De Novo request — FDA determines the device does not meet criteria for De Novo classification (typically because it is deemed Class III and requires PMA)
If declined, the applicant may:
• Resubmit as a PMA if the device is determined to be Class III • Request a meeting to discuss alternative pathways • Appeal FDA's classification decision through the Device Classification Appeal Process