REGINT.IO
FDA Regulatory Intelligence Platform
End-to-End FDA Submission Platform
From device profiling to submission-ready export. AI-powered workflow that guides regulatory teams through every step of 510(k), De Novo, and PMA submissions.
How It Works
Each project follows a structured 6-step workflow — from initial device description to a validated, export-ready submission package.
Device Profile
Define your device, intended use, and technical characteristics.
Classification
AI-powered product code identification and regulatory pathway selection.
Predicate Analysis
Find and compare predicate devices for substantial equivalence.
Risk & Safety
MAUDE adverse events, recall history, and risk profile assessment.
Testing Strategy
Performance testing plan aligned with recognized standards.
Submission Report
Generate, review, and export final submission documents.
AI Regulatory Agent
A conversational AI assistant with deep access to FDA databases, regulatory logic, and your project context.
- Multi-turn conversations with tool use — searches FDA data, analyzes predicates, reviews risk profiles in real time
- Project-scoped context — the agent understands your device, classification, and workflow progress
- Every answer backed by citations to official FDA sources
- Conversation history — pick up where you left off
FDA Intelligence Search
Hybrid AI + keyword search across the full FDA regulatory landscape — in a single interface.
Product Codes
AI-powered device classification with confidence scoring and candidate ranking.
510(k) Clearances
Search cleared devices by keyword, product code, device class, and date range.
PMA Approvals
Find approved PMA devices with faceted filtering.
De Novo Decisions
Search decision summaries, special controls, and intended use statements.
AI Document Generation
Generate regulatory documents from templates, with AI drafting, compliance checking, and version control.
- 14+ regulatory templates — 510(k) Summary, Device Description, Indications for Use, Risk Analysis, and more
- Three drafting modes: template generation, assisted editing with AI suggestions, and conversational drafting
- Built-in compliance checker flags issues before submission
- Evidence traceability — every claim linked to FDA sources with citations
- Version history and diff view for collaborative editing
- Export to PDF, DOCX, or Markdown
Analytics & Monitoring
Product code intelligence, regulatory trends, and post-market surveillance — in one dashboard.
- Product code analytics — clearance statistics, review times, trend visualization
- Advisory intelligence — gap analysis, regulatory strategy, submission comments
- Post-market surveillance dashboard with risk alerts
- Product code monitoring subscriptions with notifications
- Recall timelines and adverse event tracking via MAUDE integration
Submission Readiness & Export
Know exactly where your submission stands — and export a validated package when you are ready.
- Readiness assessment — each required document tracked as ready, draft, or missing
- Pre-export validation catches gaps before you submit
- One-click export of the complete submission package
- Full audit trail — every action logged for compliance
- Cloud drive per project for supporting files and evidence
Team Collaboration
Built for regulatory teams — with role-based access, organizations, and shared workspaces.
- Organizations with role-based access — Owner, Admin, Regulatory Lead, Reviewer, Client
- Guided and Professional modes — choose the interface that fits your experience level
- Project-level audit log for compliance and accountability
- Bookmark and organize resources across the platform
Built on Official FDA Sources
All data sourced directly from official regulatory databases. Updated regularly.
openFDA API
510(k) clearances, PMA approvals, adverse events, recalls, and product codes.
FDA AccessData
Device classification, De Novo decisions, guidance documents.
eCFR
21 CFR Subchapter H — Code of Federal Regulations for medical devices.
Who Uses RegInt
Medical Device Manufacturers
Manage the full 510(k), De Novo, or PMA submission lifecycle in one platform.
Regulatory Consultants
Accelerate client work with AI-powered search, classification, and document generation.
Cross-Border Product Teams
Centralize regulatory intelligence for teams preparing submissions across markets.
Compliance & QA Organizations
Monitor post-market signals, track adverse events, and maintain audit-ready records.
Partnership Program
Three integration models for regulatory consultants, medtech platforms, and RA/QA teams.
OEM / White-Label
Co-branded or white-label modules for medtech and workflow platform vendors.
Embedded
Embed regulatory intelligence in existing products via API and guided UI.
Direct Pilot
Run direct pilot programs for RA/QA teams with clear qualification milestones.
Get Started
Create a free account to explore the platform, or contact us for a demo.