Startup
For teams entering the AI device market
- AI/ML clearance database (950+ devices)
- Predicate search for AI devices
- De Novo monitor
- FDA guidance tracker with summaries
- Basic alert: weekly digest email
Pricing
All plans include a 14-day free trial. No credit card required, cancel anytime.
For teams entering the AI device market
For active regulatory strategy
For teams, large device companies, and investors
Compare Plans
| Capability | Startup | Professional | Enterprise |
|---|---|---|---|
| AI/ML clearance database | ✓ | ✓ | ✓ |
| Predicate search | ✓ | ✓ | ✓ |
| De Novo monitor | ✓ | ✓ | ✓ |
| Guidance tracker + summaries | ✓ | ✓ | ✓ |
| PCCP tracker | — | ✓ | ✓ |
| Competitive intelligence & charts | — | ✓ | ✓ |
| Enforcement & warning letter monitor | — | ✓ | ✓ |
| MAUDE adverse event monitor | — | ✓ | ✓ |
| Regulatory timeline builder | — | ✓ | ✓ |
| Alerts | Weekly digest | Real-time | Real-time |
| API access | — | — | ✓ |
| Custom indication tracking | — | — | ✓ |
| Team seats | 1 | 5 | Unlimited |
| Support | Priority |
FAQ
All data is sourced from publicly available FDA databases, including the 510(k) clearance database, De Novo decisions, guidance document repository, warning letter database, and MAUDE adverse event reports. AIFDA Intel does not use licensed, proprietary, or non-public data sources.
Data is synced daily from FDA's public databases. Each data page displays a "last synced" timestamp. FDA's own publication timelines mean some records may not appear immediately after FDA action. Always verify directly at FDA.gov for time-sensitive regulatory decisions.
No. AIFDA Intel is a research and intelligence tool. It summarizes and organizes public FDA records. Nothing on this platform constitutes regulatory advice, legal counsel, or a prediction of FDA clearance outcomes. For regulatory strategy or legal questions, consult a qualified regulatory affairs professional or attorney.
Yes. AIFDA Intel does not store, process, or display patient health information. All data is device-level and company-level public regulatory records. No Business Associate Agreement (BAA) is required.
All account and application data is stored on SOC 2 Type II certified infrastructure. Data is encrypted at rest and in transit. We do not store payment card details — all billing is processed by Stripe. Full details are in our Privacy Policy.
Yes. All plans are monthly. Cancel anytime from your account settings. Your access continues until the end of the current billing period.
AIFDA Intel provides access to publicly available FDA records for research and informational purposes. It does not constitute regulatory or legal advice, and is not a substitute for a qualified regulatory affairs consultant or attorney.
14 days free. No credit card required. Cancel anytime.
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