Your FDA pathway, AI-built.
Expert-reviewed.
Complizen’s AI builds your regulatory strategy — pathway, predicate shortlist, requirements map, risk gaps — and a senior FDA expert reviews every section, refines it, and walks you through it on a 1-hour call.
- Fixed fee
- One-week turnaround
- FDA expert debrief
- Credited toward 510(k) service
A regulatory strategy you can defend — AI-built, expert-reviewed.
AI does the analysis at speed. A senior FDA expert reviews and refines every piece before it lands in your inbox.
Pathway recommendation
510(k), De Novo, PMA, or exempt — with rationale, device class, product code, and 21 CFR citation. Defensible to investors and FDA.
Predicate shortlist
Top 5 clearances ranked by similarity, with an initial SE comparison framework to anchor your submission.
Requirements map
Every testing, documentation, and labeling requirement for your pathway — mapped to eSTAR sections and prioritized.
Risk & gap analysis
Where your device is most likely to face FDA questions — novel features, biocompatibility, software, combination products — with suggested mitigations.
Timeline & budget
Realistic timeline to FDA submission with key milestones. Budget estimate for testing, user fees, and Complizen tiers.
Q-Sub recommendation
Whether a Pre-Submission meeting is worth pursuing for your device — and if so, what questions to bring to FDA.
Which pathway is right for your device?
| Pathway | Device class | Typical timeline | User fee (FY2025) | When to use |
|---|---|---|---|---|
| Traditional 510(k)Most common | Class II | 6–12 months | $24,320 | Substantially equivalent to a cleared predicate |
| Special 510(k) | Class II | 3–6 months | $24,320 | Design changes to your own cleared device |
| De Novo | Class II (novel) | 12–24 months | $37,000 | Novel device with no cleared predicate — creates a new product code |
| PMA | Class III | 2–4 years | $456,000+ | High-risk device — life-sustaining or implanted |
| Exempt | Class I / some II | No review | $0 | Low-risk device meeting specific exemption criteria |
User fees as of FY2025. Timelines based on current CDRH performance data — subject to change.
“The regulatory strategy review pointed us at the right pathway from day one — with citations. We knew we weren't missing something critical, and that confidence is hard to put a price on.”
Fixed fee. One week. Full report.
- Full regulatory strategy report
- 1-hour FDA expert debrief call
- 2 weeks of follow-up Q&A
- 100% credited toward 510(k) service
Build the same strategy with AI alone.
With a Complizen Starter plan, you can build your regulatory strategy on the platform — same AI, same Superagent, no expert session or 1-hour call.