Empowering Innovators: AI-Powered FDA 510(k) and PMA Guide

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Regal Intel delivers exceptional FDA 510(k) and PMA Submission Services designed to accelerate your medical device's journey from concept to patient access. Our comprehensive expertise leverages AI to streamline submission preparation, generate real-world evidence (RWE), and provide guidance on novel regulatory pathways for innovative devices, diagnostics, and Software as a Medical Device (SaMD).

Our AI-powered approach encompasses thorough regulatory strategy development, predicate device analysis, and submission pathway optimization. We provide expert guidance on classification determinations, substantial equivalence demonstrations for 510(k)s, and comprehensive support for the more complex De Novo and PMA submissions. Our services include:

• AI-Driven RWE Generation: We use AI to transform real-world data (RWD) into compelling RWE to support your submission and address FDA reviewer concerns. The FDA is increasingly encouraging the use of RWE to demonstrate clinical validity, which is a major point of focus for AI-enabled devices.
• AI-Powered Documentation: We leverage AI to streamline the submission process by assisting with the compilation of documentation, and ensuring that all components are meticulously prepared and organized for seamless electronic submission. This can significantly reduce human error and time spent on administrative tasks.
• Novel AI Regulatory Pathways: We stay current with specialized FDA policies and guidances for AI/ML-based SaMD, including the use of Predetermined Change Control Plans (PCCP) and other lifecycle management frameworks. We ensure your submission meets all criteria for transparency, bias mitigation, and performance testing.

Choosing Regal Intel for your FDA submission needs means partnering with a non-profit dedicated to accelerating patient access.

• Integrated Solutions: We provide integrated solutions from initial consultation to post-market compliance, combining deep regulatory expertise with AI-powered quality systems guidance. The FDA is already using AI to streamline its own review processes, so a modern submission strategy must align with this trend.
• Non-Profit Mission: Our non-profit status allows us to provide cost-effective services while maintaining deep expertise in rare disease medical device pathways and specialized regulatory requirements. We offer mission-aligned consulting services focused on accelerating patient access rather than profit maximization.
• FDA-AI Alignment: The FDA has issued draft guidance on how to regulate AI-enabled medical devices, emphasizing a Total Product Life Cycle (TPLC) approach. Our approach is designed to align with these recommendations, from development and validation to post-market monitoring, which can help manufacturers accelerate AI technology deployment in healthcare.