FDA Regulatory Intelligence

The FDA Intelligence Layer for AI Medical Devices.

Track every clearance, predicate, guidance update, and enforcement action — before your competitors do.

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Live Clearance Feed LIVE
✓510(k) K243821 cleared — Viz.ai stroke detection AI2 min ago
✓De Novo DEN220043 — new product code QMF created1 hr ago
⚠Warning letter — [Company redacted] AI diagnostic system3 hrs ago
✓New PCCP approved — algorithm retrain without new 510(k)Yesterday

ⓘ AIFDA Intel is an independent commercial platform and is not affiliated with, endorsed by, or connected to the U.S. Food and Drug Administration.

950+
AI/ML devices cleared by FDA
47
De Novo decisions creating new AI product codes
12
FDA guidance documents on AI regulation
3×
YoY growth in AI device submissions

The Problem

The FDA data exists. Finding it is the problem.

01

The list isn't a database

FDA publishes a static spreadsheet of AI-cleared devices. No filters, no predicates, no context, no alerts. You're doing this manually.

02

Guidance is scattered across dozens of PDFs

FDA's AI regulation framework spans action plans, draft guidances, discussion papers, and docket submissions going back to 2019. No one has connected them to device-level data.

03

Your competitors' clearances are public. Most companies miss them.

Every 510(k) summary is a public document. AIFDA Intel turns that into competitive intelligence — who's getting cleared, how fast, on what predicate.

Who It's For

Built for everyone who can't afford to miss an FDA move.

AI Medical Device Startups

  • Know which AI predicates are available for your indication
  • Track PCCP patterns before you design your ML pipeline
  • Get alerted the moment a competitor clears

Regulatory Consultants

  • Brief clients with current competitive context, not static spreadsheets
  • Track FDA's enforcement posture on AI devices
  • Monitor guidance changes across all your client indications at once

Investors & Due Diligence Teams

  • Assess regulatory risk before term sheets
  • Understand market positioning — first mover vs crowded indication
  • Historical clearance velocity data by device category

In-House RA Teams at Large Device Cos

  • Monitor the full AI device landscape without manual FDA searches
  • Early warning on enforcement trends
  • Regulatory timeline estimates based on similar cleared devices

The Platform

Everything FDA publishes, connected and current.

AI/ML Clearance Database

950+ cleared devices, fully tagged. Filter by indication, device class, algorithm type, and clearance date.

Predicate Intelligence

Find which AI devices are being used as predicates and how often. Built on the same infrastructure as Predicase.

PCCP Tracker

The only tool tracking Predetermined Change Control Plans. Know what algorithm changes FDA accepts without a new 510(k).

Competitive Intelligence

See who dominates each AI indication. First-mover analysis, clearance velocity, investor-grade charts.

FDA Guidance Monitor

Every AI-related FDA guidance, draft, and action plan in one place. Plain-English summaries included.

Smart Alerts

Get notified when a competitor clears, when FDA publishes new guidance for your product code, or when a PCCP is approved in your space.

See all 10 features →

FDA published 3 new AI device clearances this week. Did you know?

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