Key Performance Metrics

• +60% Submission Velocity - Faster FDA clearance timelines through AI-automated documentation and intelligent predicate analysis
• 89% First-Pass Acceptance - Industry-leading success rate achieved through predictive deficiency analysis trained on 50,000+ FDA decisions
• -40% Cost Optimization - Lower than traditional consultants through automated compliance checking and documentation generation
• 2.4 Million Documents Analyzed - Real-time monitoring of FDA guidance, warning letters, and regulatory updates
• 500+ Regulatory Protocols - Comprehensive service catalog covering all FDA submission pathways

FDA Regulatory Services

Our comprehensive regulatory services span the entire medical device lifecycle, from initial concept through post-market surveillance.

• 510(k) Premarket Notification - AI-accelerated substantial equivalence submissions with automated predicate device matching and gap analysis. Our system identifies optimal predicate devices from the FDA database and generates comparison matrices that highlight equivalence pathways.
• PMA Premarket Approval - Class III high-risk device pathway optimization with clinical data strategy, module preparation, and FDA meeting support. We guide manufacturers through the rigorous PMA process with data-driven insights.
• De Novo Classification - Novel device pathway strategy for devices without predicates, including risk-based classification determination and special controls development.
• Breakthrough Device Designation - Expedited review for life-threatening conditions with strategic designation requests and enhanced FDA interaction protocols.
• AI/ML Medical Device Compliance - Software as a Medical Device (SaMD) and algorithm submission expertise, including predetermined change control plans and continuous learning algorithm documentation.
• Post-Market Surveillance - Real-world evidence collection, adverse event monitoring, and lifecycle compliance management for marketed devices.
• Global Harmonization - EU MDR, MDSAP, and international market access with multi-jurisdictional submission coordination.
• Pre-Submission Meetings - FDA Pre-Sub preparation with question strategy, briefing document development, and mock Q&A sessions.
• Clinical Trial Design - Regulatory-aligned protocol development, endpoint optimization, and IDE submission support.
• Quality Management Systems - 21 CFR Part 820 compliance, QMSR implementation, and ISO 13485 integration.

ARCS Scientific Technology Platform

Our proprietary technology stack represents the most advanced regulatory intelligence system available. Six interconnected analytical frameworks process regulatory data in real-time to deliver predictive insights and automated compliance.

• ARCS - Adaptive Regulatory Compliance System provides real-time FDA guidance monitoring and automated compliance gap detection. The system continuously scans FDA databases, guidance documents, and warning letters to identify relevant regulatory changes.
• OmniSynth - Multi-Domain Intelligence Fusion synthesizes data from clinical trials, regulatory databases, and market intelligence to provide comprehensive submission context and competitive positioning.
• V-Framework - Probabilistic Outcome Modeling trained on 50,000+ FDA decisions predicts approval likelihood, identifies risk factors, and recommends mitigation strategies with 94% accuracy.
• HPAS - High-Performance Analytical System for deficiency prediction analyzes historical FDA responses to identify common deficiency patterns and preemptively address potential issues.
• ARCF - Adaptive Regulatory Compliance Framework generates audit-ready documentation with automated 21 CFR Part 11 compliance, electronic signatures, and complete audit trails.
• ECIA-7 - Enhanced Competitive Intelligence Architecture provides market positioning analysis, competitor submission tracking, and strategic pathway recommendations.

Who We Serve

FDA Fast Track Institute serves organizations across the medical technology ecosystem, from innovative startups to Fortune 500 manufacturers.

• Medical Device Manufacturers - End-to-end regulatory pathway optimization for companies seeking FDA clearance or approval. We support Class I, II, and III devices across all therapeutic areas.
• MedTech Startups - Accelerated time-to-market for innovative devices with capital-efficient regulatory strategies and investor-ready documentation.
• Clinical Research Organizations - Trial design optimization, regulatory strategy alignment, and submission support for contract research organizations.
• Law Firms - White-label regulatory intelligence for MedTech-focused legal practices, including due diligence support and expert witness services.
• Investment Firms - Regulatory due diligence for portfolio companies, acquisition targets, and investment opportunities in the medical device sector.
• Pharmaceutical Companies - Combination product submissions, drug-device interface management, and cross-center coordination strategies.

Client Success Stories

Our clients consistently achieve faster approvals and higher success rates than industry averages.

• Fortune 500 Medical Device Company reduced 510(k) submission timeline from 18 months to 7 months using our AI-driven approach, achieving first-pass FDA acceptance.
• Series B MedTech Startup achieved first-pass FDA acceptance on De Novo submission after our predictive compliance modeling identified and resolved potential deficiencies.
• Multinational Diagnostics Manufacturer enabled simultaneous FDA and EU MDR submissions through our global harmonization expertise, cutting market entry time by 40%.

Frequently Asked Questions

How much does FDA Fast Track support cost?

Costs vary by device complexity, but ARCS Scientific's AI-driven approach typically reduces consultancy fees by 40-60% compared to traditional firms by automating documentation and predicate analysis. Contact us for a customized quote based on your specific device and regulatory pathway.

What is the timeline for 510(k) approval?

Traditional 510(k) review takes 90 days from FDA receipt, but preparation often takes 6-9 months. ARCS reduces preparation time to 2-3 months via automated documentation, intelligent predicate matching, and predictive gap analysis.

How does ARCS Scientific improve approval odds?

ARCS utilizes a proprietary Deficiency Predictor engine that analyzes over 50,000 past FDA rejections to identify and fix potential issues in your submission before the FDA ever sees them. This predictive approach significantly raises first-pass acceptance rates to 89%.

What is the difference between 510(k) and PMA?

510(k) is a premarket notification demonstrating a device is substantially equivalent to a legally marketed predicate device. PMA (Premarket Approval) is a more rigorous process for high-risk Class III devices requiring independent clinical data demonstrating safety and effectiveness. ARCS supports both pathways.

Can ARCS help with international submissions?

Yes, our global harmonization services support EU MDR compliance, MDSAP certification, and market access in over 50 countries. We coordinate multi-jurisdictional submissions to minimize redundant work and accelerate global market entry.

What types of medical devices do you support?

We support all medical device types including diagnostic devices, therapeutic devices, surgical instruments, implantables, wearables, digital health solutions, AI/ML-enabled devices, combination products, and in-vitro diagnostics across all FDA device classifications.

Knowledge Base Resources

Access our comprehensive library of regulatory intelligence resources, guidance documents, and methodology papers.

• FDA QMSR Requirements Guide - Comprehensive analysis of Quality Management System Regulation changes, implementation timeline, and compliance requirements for medical device manufacturers transitioning from 21 CFR 820.
• AI/ML Medical Device Submission Guide - Best practices for incorporating artificial intelligence and machine learning components in FDA regulatory submissions following the latest FDA guidance.
• Breakthrough Device Designation Strategy - Step-by-step approach to securing and maximizing Breakthrough Device Designation benefits for innovative medical technologies.
• Post-Market Surveillance in Digital Health - Leveraging real-world data and digital health tools for enhanced post-market monitoring and FDA compliance.
• FDA Regulatory Guides Library - Comprehensive pathway documentation and submission requirements for 510(k), PMA, De Novo, and expedited review programs.
• ARCS Methodology Papers - Technical documentation on our proprietary ARCS, ARCF, OmniSynth, V-Framework, HPAS, and ECIA-7 analytical frameworks.

21 CFR Part 11 Compliance

All ARCS Scientific systems are fully compliant with 21 CFR Part 11 requirements for electronic records and electronic signatures. Our platform provides complete audit trails, user authentication, data integrity controls, and system validation documentation required for FDA-regulated environments.

Regulatory Disclaimer

FDA Fast Track Institute is an independent advisory organization operating under ARCS Scientific. We maintain no affiliation, endorsement, or formal association with the U.S. Food and Drug Administration or any federal regulatory agency. Our services provide regulatory strategy and documentation support; final approval decisions rest solely with the FDA.