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 510(k) pathway differ from Premarket Approval (PMA)? • What is the typical timeline for a Class II device to get FDA clearance? • When is the De Novo pathway appropriate for a novel medical device? • How does the Humanitarian Device Exemption support devices for rare conditions? • What are the essential stages in the FDA medical device approval journey? • How long can manufacturers expect the FDA review process to take for different device classes? • Why is early communication with the FDA beneficial for medical device companies? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.