Your FDA pathway,
mapped by a
senior consultant.
Not sure if you need a 510(k), De Novo, PMA, or if you’re even regulated? Before you spend time and money on the wrong path, spend two weeks getting a defensible answer from someone who’s done it hundreds of times.
- Fixed fee · from $4,800
- 2-week turnaround
- Credited toward 510(k) service
A documented regulatory strategy. Not a verbal opinion.
Pathway recommendation
510(k) vs. De Novo vs. PMA vs. exempt — with supporting rationale, device class, product code, and 21 CFR citation. Defensible to investors and FDA.
Predicate shortlist
Top 5 clearances identified as potential predicates with similarity scores. Initial SE comparison framework included as a starting point for your submission.
Requirements map
Every testing, documentation, and labeling requirement for your chosen pathway — mapped to eSTAR sections and broken into a prioritized action list.
Risk & gap analysis
Flags the specific areas where your device is most likely to face FDA questions — novel features, biocompatibility, software, combination product status — with suggested mitigations.
Timeline & budget estimate
Realistic timeline from your current state to FDA submission, with key milestones. Budget estimate for testing, user fees, and Complizen service tiers.
Q-Sub recommendation
A clear recommendation on 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.”
- Full strategy report (10–20 pages)
- 1-hour consultant debrief call
- 2 weeks of follow-up Q&A
- 100% credited toward 510(k) service