De Novo Timelines & FDA Interaction
MDUFA VI performance goals
Under MDUFA VI, FDA's target for De Novo requests is:
| Milestone | Goal |
|---|---|
| Acceptance review | 15 business days |
| Total Time to Decision | 150 calendar days |
| Substantive interaction | 100 calendar days |
Pre-submission meetings (Q-Submissions)
For De Novo, a Q-submission (pre-submission meeting) before filing is strongly recommended. FDA can provide feedback on:
- Whether De Novo is the appropriate pathway
- Proposed intended use and indications
- Performance testing requirements
- Clinical study design (if needed)
- Proposed special controls framework
Q-submissions are free and FDA's target response time is 90 days (or 60 days for a meeting request).