FDA Fast Track Institute
AI-powered regulatory intelligence to accelerate medical device submissions and transform complexity into predictable, defensible clearance pathways
FDA Fast Track Institute is a specialized advisory organization powered by ARCS Scientific's advanced AI technology. The platform is engineered to accelerate the entire lifecycle of medical device regulatory submissions to the U.S. Food and Drug Administration. By leveraging a proprietary engine that analyzes millions of regulatory documents, the Institute helps medical technology companies navigate complex compliance pathways for 510(k), PMA, De Novo, and Breakthrough Device designations, significantly reducing submission times and increasing the likelihood of first-pass acceptance.
The core of the Institute's methodology is its AI-powered predictive compliance, which identifies and remediates potential submission gaps before they are reviewed by the FDA. This data-driven approach transforms regulatory complexity into a predictable and defensible process, offering automated documentation, intelligent predicate device matching, clinical trial design optimization, and post-market surveillance - all secured with military-grade data isolation to ensure intellectual property protection.
Available at No Cost to Synergistic NGOs, Think Tanks, Institutes & Nonprofits
FDA Fast Track Institute is provided entirely free of charge to synergistic NGOs, think tanks, research institutes, and other mission-driven nonprofits. All services across the Embassy Row Project ecosystem are personally funded by James Scott - no fees, no subscriptions, no hidden costs.
Access is managed through the Embassy Row Project's grant program, which exists to remove financial barriers so qualifying organizations can deploy institutional-grade capabilities and redirect their resources toward advancing their core mission.
Service Categories
Premarket Submissions
- 510(k) Premarket Notification
- PMA Premarket Approval
- De Novo Classification
Advanced Designations
- Breakthrough Device Designation
- AI/ML Medical Device Compliance
Post-Market & Quality
- Post-Market Surveillance
- Global Harmonization
- Quality Management Systems
Key Features
Sectors Served
Access This Platform
All platform services are fully grant-funded. Apply for access to start leveraging institutional-grade intelligence for your organization.
Apply for Grant Access