Decoding FDA Medical Device Pathways

Medical Device Global Market Access · Jun 18, 2025 · 3m

This episode provides a comprehensive overview of the U.S. FDA's medical device approval process. We break down the three device risk classifications, detail the primary regulatory pathways including Premarket Notification (510(k)), Premarket Approval (PMA), De Novo, and Humanitarian Device Exemption (HDE). Listeners will also learn about the general steps from device conception to market, typical timelines for each class, and key considerations for manufacturers seeking FDA clearance or approval. Key Questions: • What are the FDA's risk classifications for medical devices? • How does the…