Pricing

One platform. Three tiers.

All plans include a 14-day free trial. No credit card required, cancel anytime.

Startup

$299/mo

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
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Most popular

Professional

$599/mo

For active regulatory strategy

  • Everything in Startup, plus
  • PCCP tracker
  • Competitive intelligence & clearance charts
  • Enforcement & warning letter monitor
  • MAUDE adverse event monitor
  • Real-time alerts (clears, guidance, PCCPs)
  • Regulatory timeline builder
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Enterprise

Custom

For teams, large device companies, and investors

  • Everything in Professional, plus
  • Full API access
  • Custom indication tracking
  • Unlimited team seats
  • Priority support
  • Custom data exports
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Compare Plans

What's in each tier.

CapabilityStartupProfessionalEnterprise
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
AlertsWeekly digestReal-timeReal-time
API access
Custom indication tracking
Team seats15Unlimited
SupportEmailEmailPriority

FAQ

Questions, answered.

What data sources does AIFDA Intel use?+

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.

How current is the data?+

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.

Is this regulatory or legal advice?+

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.

Is this suitable for HIPAA-regulated environments?+

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.

Where is my data stored and is it secure?+

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.

Can I cancel anytime?+

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.

Start your free trial today.

14 days free. No credit card required. Cancel anytime.

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