One platform. Zero noise.

Because regulatory noise is the problem. General platforms like Citeline cover 50,000+ device clearances. AIFDA Intel covers only the ~1,000 AI and ML-enabled devices — the ones that actually matter to you. That means every alert, every predicate, every benchmark is relevant. No filtering required.

All data is sourced from publicly available FDA databases — 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.

Citeline and similar platforms cover all medical devices at $800-2,000/month. AIFDA Intel is purpose-built for AI devices at a fraction of the cost. If you're building an AI medical device, you don't need data on 50,000 orthopedic and wound care clearances — you need deep, connected intelligence on the ~1,000 AI-specific ones.

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. Consult a qualified regulatory affairs professional or attorney for regulatory strategy.

Yes. All plans are monthly. Cancel anytime from your account settings. Your access continues until the end of the current billing period.

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.