About

A database, not an advisor.

AIFDA Intel organizes what FDA publishes. It does not interpret, advise, or predict — and that boundary is not a limitation. It is the product.

What it is and isn't

Exactly what AIFDA Intel does — and doesn't — do.

✓ IsWhat AIFDA Intel is

  • 01A database tool. Search and filter FDA's public clearance records — 510(k)s, De Novos, PCCPs — by indication, algorithm type, date, and product code.
  • 02A monitoring service. Alert users when new public records appear — a competitor clears, new guidance is published, a PCCP is granted.
  • 03A research aid. Surface relationships between public records: predicate chains, PCCP patterns, enforcement history linked to cleared devices.
  • 04An information aggregator. Compile public FDA documents in one structured interface so you don't have to maintain your own FDA search stack.
  • 05A commercial SaaS product. Subscription access to a private database built from public inputs — in the same category as Bloomberg aggregating SEC filings, or CourtListener aggregating federal court records.

✕ Is notWhat AIFDA Intel is not

  • —A regulatory submission service. We help you understand the landscape. We don't prepare, review, or submit regulatory documents.
  • —A predictor of FDA clearance outcomes. Historical data shows what has cleared. It does not tell you what will clear or how fast.
  • —A source of legal or regulatory advice. Nothing on this platform constitutes regulatory counsel, legal opinion, or a recommendation about your device's regulatory path.
  • —A replacement for a qualified consultant or attorney. For regulatory strategy and legal questions, engage a qualified regulatory affairs professional or licensed attorney.
  • —An FDA-affiliated or FDA-endorsed tool. AIFDA Intel is an independent commercial platform with no connection to the U.S. Food and Drug Administration.
  • —A guarantor of data completeness or accuracy. All data is sourced from FDA's public databases and subject to FDA's own publication timelines. Verify directly at FDA.gov for consequential decisions.

Positioning statement

In plain language.

AIFDA Intel is an independent commercial research platform that aggregates, organizes, and presents publicly available records published by the U.S. Food and Drug Administration, including 510(k) clearance records, De Novo decisions, guidance documents, warning letters, and adverse event reports.

The platform is designed to assist researchers, regulatory professionals, and business analysts in efficiently accessing and analyzing public regulatory information. AIFDA Intel does not provide regulatory advice, legal counsel, or predictions regarding FDA clearance outcomes.

All data presented is sourced from FDA's public databases and is subject to FDA's own publication timelines and accuracy. As with any regulatory research, we recommend verifying critical decisions against primary sources.

The company

Lumenthis Labs LLC.

Operated by

Lumenthis Labs LLC
An independent commercial software company.

Contact

hello@aifdaintel.com
privacy@aifdaintel.com

Data & infrastructure

All regulatory data sourced from FDA's public databases. Platform infrastructure hosted on Supabase (SOC 2 Type II) and Vercel.

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