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A medical device regulatory strategy is your comprehensive plan for achieving FDA clearance or approval. It includes device classification, pathway selection (510(k), De Novo, or PMA), resource planning (team, budget, consultants), timeline mapping, testing strategy, and risk mitigation. Build it during concept phase—before design freeze or testing begins—to avoid expensive mistakes and accelerate market entry. Companies that build regulatory strategy during concept phase mak

To bring a medical device to the U.S. market: (1) Classify your device (Class I, II, or III), (2) select your regulatory pathway (510(k), De Novo, or PMA), (3) complete required testing, (4) prepare and submit your FDA application, and (5) maintain post-clearance QMS compliance. Timeline ranges from 3-6 months for 510(k) to 1-3 years for PMA. This guide provides the complete roadmap from concept to U.S. market launch, with decision frameworks at each stage to help you avoid t

The FDA’s 510(k) Third-Party Review Program (3P510k)  is a voluntary alternative pathway  allowing accredited organizations  to review certain eligible Class I and II medical devices  instead of FDA performing the full review.Third-party reviewers forward their technical recommendation to FDA, which aims to issue a final clearance decision within about 30 calendar days  of receiving the complete review package. By using the 3P510k route, you avoid paying FDA user fees , thoug

Preparing your first FDA submission involves five critical steps: classify your device accurately, determine the appropriate regulatory pathway (510(k), De Novo, or PMA), gather required technical and clinical documentation, consider engaging FDA through a Pre-Submission meeting, and submit through FDA's electronic systems with proper formatting and user fees. This guide provides practical, step-by-step preparation strategies specifically for startup founders navigating their

FDA reviews AI and machine learning medical devices using a regulatory framework designed for adaptive software that learns over time. The approach includes Predetermined Change Control Plans (PCCPs) that allow pre-approved algorithm modifications without additional submissions, Good Machine Learning Practice guidelines, and lifecycle management requirements addressing transparency and bias concerns. This guide covers FDA's AI/ML regulatory framework, submission requirements,

A Design History File (DHF) is a mandatory compilation of records documenting how a medical device was designed and developed according to FDA requirements under 21 CFR Part 820.30. The DHF demonstrates that design controls were followed throughout development and serves as primary evidence during FDA audits and regulatory submissions. This guide covers DHF requirements, contents, creation process, and compliance strategies to help you build audit-ready documentation. What Is