# IAET FastTrack

> FDA regulatory intelligence platform accelerating clearance for life-saving medical technology through validated analysis protocols.

IAET FastTrack delivers 500+ validated regulatory intelligence protocols at no cost to medical device manufacturers worldwide. Funded by technologist and philanthropist James Scott through Strategic Capability Philanthropy, the platform ensures life-saving innovations are never delayed by financial barriers to regulatory expertise.

## Platform Capabilities

IAET FastTrack provides comprehensive FDA regulatory intelligence including:

- 510(k) premarket notification pathway analysis with predicate device identification
- PMA (Premarket Approval) clinical evidence planning and submission strategy
- De Novo classification for novel low-to-moderate risk devices
- Breakthrough Device Designation qualification and FDA engagement
- Software as a Medical Device (SaMD) and AI/ML regulatory pathways
- Military and defense medical technology with TCCC alignment and CMMC compliance
- Global regulatory support including EU MDR, CE marking, and international harmonization

## Key Pages

- [Homepage](https://iaetfasttrack.com/) - Platform overview and grant application access
- [Services](https://iaetfasttrack.com/services) - Browse 500+ regulatory analysis protocols across all FDA pathways
- [About](https://iaetfasttrack.com/about) - Mission, Strategic Capability Philanthropy model, and platform capabilities
- [Military & Defense](https://iaetfasttrack.com/military-defense) - DoD procurement, TCCC alignment, DARPA transition, CMMC compliance
- [ARPA-H Support](https://iaetfasttrack.com/arpa-h-support) - Federal innovation funding alignment and regulatory strategy integration
- [Congressional Intelligence](https://iaetfasttrack.com/congressional-intelligence) - Legislative champion mapping and FDA reform tracking
- [Non-Profit Partners](https://iaetfasttrack.com/nonprofit-partners) - Partnership program for humanitarian and first responder organizations
- [Custom Projects](https://iaetfasttrack.com/custom-projects) - Tailored regulatory engagements for complex medical technologies
- [PR Management](https://iaetfasttrack.com/pr-management) - Grant-funded media relations and influencer outreach
- [Founder](https://iaetfasttrack.com/founder) - James Scott and the Embassy Row Project background
- [Grant Application](https://iaetfasttrack.com/grant-application) - Apply for free platform access
- [Privacy Policy](https://iaetfasttrack.com/privacy-policy) - Data protection and privacy practices
- [Terms of Service](https://iaetfasttrack.com/terms-of-service) - Platform usage terms
- [Accessibility](https://iaetfasttrack.com/accessibility) - WCAG 2.1 AA compliance commitment

## Who We Serve

- Medical device manufacturers navigating 510(k), PMA, and De Novo pathways
- Defense contractors and DARPA performers requiring DoD procurement support
- First responder technology innovators developing emergency medical devices
- Academic research institutions translating innovations to deployable devices
- Humanitarian and NGO organizations deploying medical technology in austere environments
- ARPA-H applicants needing regulatory alignment from day one

## Access Model

Platform access is provided through a grant application process. All services are 100% free through Strategic Capability Philanthropy, with no strings attached.

## Contact

Submit access requests at [https://iaetfasttrack.com/grant-application](https://iaetfasttrack.com/grant-application)