FDA Regulatory Consultant for Class II Medical Device Compliance

Project Overview A global leader in high power light therapy is seeking a specialized FDA Regulatory Consultant to conduct a comprehensive audit of its compliance framework. The organization manufactures infrared therapeutic heating lamps currently classified under FDA product code ILY as Class II medical devices. The objective is to evaluate regulatory standing in light of significant power output increases to ensure sustained market access and risk mitigation. Scope of Work Claims Review: Perform a critical audit of marketing collateral, instructions for use, and digital content to ensure therapeutic claims—including those for inflammation, circulation, and muscle recovery—adhere to Class II over-the-counter (OTC) regulations. Safety & Reporting Evaluation: Review procedures for monitoring and addressing risks such as unwanted photoaging or high-intensity near-infrared (NIR) exposure. Registration & Listing Verification: Confirm the accuracy of FDA Establishment Registrations for domestic and international facilities. Quality System Compliance: Advise on 21 CFR Part 820 requirements specifically for devices incorporating multiple LED bands and pulsing functionality. Required Qualifications Extensive experience with FDA Class II medical devices, specifically within the infrared therapeutic heating lamp category. Demonstrated expertise in 510(k) exemptions and the ILY product code. Experience auditing high-performance technical specifications, including spectral radiant flux and irradiance values. Ability to reconcile professional-grade performance marketing with strict regulatory constraints. Strategic Objective The consultant must ensure that technological advancements—specifically individual arenaflex control and a 50% increase in power output—do not inadvertently trigger a higher risk classification that would require full 510(k) clearance or PMA. We require an objective strategist to challenge assumptions regarding market positioning versus regulatory safety thresholdsApply Now

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