Is your product a medical device — and if so, which FDA pathway applies? This engagement covers device classification under 21 CFR Part 868, intended use analysis, SaMD determination under IMDRF criteria, and a recommended regulatory pathway with rationale. Delivered as a written assessment with next-step recommendations.
Is your product a medical device — and if so, which FDA pathway applies? This engagement covers device classification under 21 CFR Part 868, intended use analysis, SaMD determination under IMDRF criteria, and a recommended regulatory pathway with rationale. Delivered as a written assessment with next-step recommendations.